Systems and methods for aggregating pharmaceutical testing supply orders

Abstract

Embodiments of the present disclosure include a system and method for confidentially generating shipping orders for clinical trials. The method includes receiving a plurality of supply orders associated with one or more clinical trials and determining clinical trial studies, site locations, and treatment types. The first plurality of supply orders are assigned to packaging sites based on the site locations. The method further includes associating a first subgroup of the first plurality of supply orders with a first assembly procedure, associating a second subgroup of the first plurality of supply orders with a second assembly procedure, and creating a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first subgroup and the second subgroup. The method further includes confidentially generating shipping orders for the first plurality of clinical trials based on the plurality of blinded kits.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 411,333, filed September 29, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to systems and methods for generating shipping orders for clinical trials, and more particularly to systems and methods for confidentially generating shipping orders for blinded clinical trial studies. [Background technology]

[0003] Companies engaged in clinical trial research, particularly pharmaceutical clinical trials, are required to comply with government-regulated clinical packaging and labeling standards. For example, various national agencies, such as the Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA), provide regulatory frameworks for clinical packaging. Therefore, each clinical packaging operation, whether primary packaging (e.g., placing bulk drug into bottles, blisters, or vials) or secondary packaging (e.g., applying clinical labels to primary bottles, placing them in boxes, and labeling boxes to create patient kits), must be a controllable, repeatable action and follow appropriate regulatory guidelines. Furthermore, packaging should be done in a way that does not reveal which kits are associated with which treatment type (e.g., a participant or another individual involved in the clinical trial could discover whether a kit is an active treatment or a placebo, thereby unblinding the clinical trial).

[0004] Traditionally, packaging methods for clinical trial studies may be implemented to prepare large quantities of kits containing drugs for clinical trial studies. The kits may include primary packaging containers (e.g., a bottle, blister pack, or vial containing the drug) and secondary packaging containers (e.g., a box containing the primary packaging container and instructions). These kits are stored at the facility and packaged for shipment upon receiving a request for the kit to a specific clinical trial site location. Recently, there has been a shift from pre-packaging and storing large quantities of kits to providing just-in-time packaging, in which kits are packaged at or around the time a request is received. Just-in-time packaging can reduce waste by packaging only what is requested. For example, this can be achieved when a drug is in limited supply, when a clinical trial study is not progressing in a particular country, or when the expected level of patient enrollment is not achieved.

[0005] Just-in-time packaging can be inefficient. Clinical trial studies often include one or more active agents or treatment types and a control or placebo treatment. During the packaging process, each active and control treatment type is prepared and packaged in a separate packaging run. Each packaging run can be associated with packaging room setup, packaging room cleaning, and separate review and release of packaged product for each treatment type. For just-in-time packaging with relatively small kit quantities, the time and cost can be substantial. Additionally, packaging should be done in a manner that does not reveal which kit is associated with which treatment type (e.g., a participant or another individual involved in the study could discover whether the kit is an active treatment or a placebo, thereby unblinding the study). Therefore, kits for clinical trial studies must be packaged confidentially and efficiently. Summary of the Invention [Means for solving the problem]

[0006] Embodiments of the present disclosure may provide a computing system and method for efficiently aggregating supply orders. Each supply order may be associated with a destination site associated with a site location that may distribute one or more products or kits to participants in a clinical trial study. In one or more examples, multiple supply orders may be aggregated to create one or more larger assembly orders, each associated with a particular treatment type (e.g., an active treatment type or a control treatment type). Each assembly order may correspond to a packaging run to prepare kits for one or more clinical trial site locations. Embodiments of the present disclosure may further disassemble kits produced in a packaging run to generate shipping orders based on the original supply order.

[0007] In one or more examples, embodiments of the present disclosure can improve the efficiency of just-in-time packaging processes, where clients may place supply orders in real time for immediate needs at a site location. As a result, each supply order may correspond to a relatively small packaging run (e.g., less than 100 kits) and not to long-term demand (more than 100 kits). In some examples, supply orders may include quantities of less than five kits. Packaging supply orders to meet real-time demand can be time-consuming and costly, as each packaging run may be associated with room setup, room cleaning, and individual review and release of the packaged product. Aggregation of supply orders according to embodiments of the present disclosure can lead to increased efficiency by reducing the time and costs associated with multiple supply runs for a single supply order.

[0008] Additionally, embodiments of the present disclosure may lead to improved confidentiality when generating shipping orders for blinded studies. Often, for a clinical trial to be successful, both participants and clinical trial administrators should not know which dosing kits correspond to active or control treatment types. Often, a randomization list is used to map kits (e.g., kit identifiers) to treatment types (e.g., active or control). Embodiments of the present disclosure provide an improved method of maintaining the confidentiality of the randomization list by restricting access to the randomization list. In one or more examples, this is achieved by maintaining the randomization list on a computer system associated with a packaging facility (e.g., the facility that packages the kits). In one or more examples, other parts of the system may not have access to the randomization list.

[0009]

[0006] Embodiments of the present disclosure provide a method for covertly generating shipping orders for clinical trials. In one or more examples, the method includes receiving, at a first computer system including one or more processors and one or more memories, a plurality of supply orders associated with one or more clinical trials; determining a clinical trial study, a site location, and a treatment type for each of the plurality of supply orders; and allocating the first plurality of supply orders associated with the first clinical trial study to a packaging site based on the site location. In one or more examples, the method further includes associating a first subgroup of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order, and associating a second subgroup of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order. In one or more examples, the method further includes receiving, at a second computer system including a second one or more processors and a second one or more memories, the first assembly order and the second assembly order, and creating a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order. In one or more examples, the method further includes secretly generating, at the first computer system, shipping orders for the first plurality of clinical trials based on the plurality of blinded kits.

[0010] In one or more examples, embodiments of the present disclosure include an electronic system including one or more processors, a memory, and one or more programs, the one or more programs stored in the memory and configured to be executed by the one or more processors. In one or more examples, the one or more programs further include instructions, at a first computer system including the one or more processors and the one or more memories, for receiving a plurality of supply orders associated with one or more clinical trials, determining a clinical trial study, a site location, and a therapy type for each of the plurality of supply orders, and allocating the first plurality of supply orders associated with the first clinical trial study to packaging sites based on the site location. In one or more examples, the one or more programs further include instructions for associating a first subgroup of the first plurality of supply orders with a first assembly procedure based on the therapy type to create a first assembly order, and associating a second subgroup of the first plurality of supply orders with a second assembly procedure based on the therapy type to create a second assembly order. In one or more examples, the one or more programs include instructions, at a second computer system including a second one or more processors and a second one or more memories, for receiving the first assembly order and the second assembly order and creating a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order. In one or more examples, the one or more programs include instructions, at the first computer system, for covertly generating shipping orders for the first plurality of clinical trials based on the plurality of blinded kits.

[0011] In one or more examples, embodiments of the present disclosure further include a non-transitory computer-readable storage medium storing one or more programs, the one or more programs including instructions that, when executed by one or more processors of one or more electronic devices having a display, cause the one or more electronic devices to: receive, at a first computer system including one or more processors and one or more memories, a plurality of supply orders associated with one or more clinical trials; determine, for each of the plurality of supply orders, a clinical trial study, a site location, and a treatment type; and assign the first plurality of supply orders associated with the first clinical trial study to packaging sites based on the site location. In one or more examples, the one or more electronic devices are further caused to associate a first subgroup of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order, and to associate a second subgroup of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order. In one or more examples, the one or more electronic devices are further caused to receive, at a second computer system including a second one or more processors and a second one or more memories, the first assembly order and the second assembly order, and to create a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order. In one or more examples, the one or more electronic devices are further caused to confidentially generate, at the first computer system, shipping orders for the first plurality of clinical trials based on the plurality of blinded kits. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 illustrates an exemplary process for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 2]FIG. 1 illustrates an exemplary assembly order, according to some embodiments of the present disclosure. [Figure 3A] FIG. 1 illustrates an exemplary process for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 3B] FIG. 1 illustrates an exemplary process for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 3C] FIG. 1 illustrates an exemplary process for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 3D] FIG. 1 illustrates an exemplary process for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 3E] FIG. 1 illustrates an exemplary process for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4A] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4B] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4C] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4D] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4E] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4F] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4G]FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4H] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4I] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 4J] FIG. 10 illustrates an exemplary user interface for confidentially generating a shipping order, according to some embodiments of the present disclosure. [Figure 5] FIG. 1 illustrates an exemplary electronic device according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] Embodiments of the present disclosure may provide systems and methods for efficiently aggregating supply orders. Each supply order may be associated with a destination site associated with a site location that may distribute one or more products or kits to participants in a clinical trial study. In one or more examples, the supply orders may be aggregated to create one or more assembly orders, each associated with a particular treatment type (e.g., an active treatment type or a control treatment type). Each assembly order may correspond to a packaging run to prepare kits for one or more clinical trial site locations. Embodiments of the present disclosure may further disassemble kits produced in the packaging run to generate shipping orders based on the supply orders.

[0014] In one or more examples, embodiments of the present disclosure can improve the efficiency of just-in-time packaging processes, where clients may place supply orders in real time for immediate needs at a site location. In just-in-time packaging processes, each supply order may correspond to a relatively small packaging run (e.g., including fewer than 100 kits). In some examples, a supply order may include quantities of fewer than five kits. Packaging supply orders to meet real-time demand can be time-consuming and costly, as each packaging run may be associated with room setup, room cleaning, and individual review and release of the packaged product. Aggregation of supply orders according to embodiments of the present disclosure can lead to increased efficiency by reducing the time and costs associated with multiple supply runs for a single supply order.

[0015] Additionally, embodiments of the present disclosure may lead to improved confidentiality when generating shipping orders for blinded studies. Often, for a clinical trial to be successful, both participants and clinical trial administrators should not know which dosing kits correspond to active or control treatment types. Often, a randomization list is used to map kits (e.g., kit identifiers) to treatment types (e.g., active or control), regardless of whether the randomization is performed by the entity running the clinical trial or by a vendor or service provider associated with that entity. Embodiments of the present disclosure provide an improved method of maintaining the confidentiality of the randomization list by restricting access to the randomization list. In one or more examples, this is achieved by maintaining the randomization list on a computer system associated with the packaging facility (e.g., the facility that packages the kits). In one or more examples, other parts of the system may not have access to the randomization list.

[0016] The following description is presented to enable those skilled in the art to make and use various embodiments. Descriptions of specific devices, techniques, and applications are provided only as examples. Various modifications to the examples described herein will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other examples and applications without departing from the spirit and scope of the various embodiments. Accordingly, the various embodiments are not intended to be limited to the examples described and shown herein, but are to be accorded the scope consistent with the claims.

[0017] In the following description, terms such as "first" and "second" are used to describe various elements, but these elements should not be limited by these terms. These terms are merely used to distinguish one element from another. For example, a first graphical representation may be referred to as a second graphical representation, and similarly, a second graphical representation may be referred to as a first graphical representation, without departing from the spirit of the described embodiment. The first graphical representation and the second graphical representation are both graphical representations, but are not the same graphical representation.

[0018] The terminology used in the description of the various embodiments set forth herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present invention. As used in the description of the various embodiments set forth herein and in the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Additionally, the term "and / or," as used herein, will be understood to refer to and encompass any and all possible combinations of one or more of the associated listed items. It will be further understood that the terms "includes," "including," "comprises," and / or "comprising," as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0019] The word "if" is optionally interpreted to mean "when," "upon," or "in response to determining," or "in response to detecting," depending on the context. Similarly, the phrases "if it is determined" or "if [a stated condition or event] is detected" are optionally interpreted to mean "upon determining" or "in response to determining," or "upon detecting [the stated condition or event]" or "in response to detecting [the stated condition or event]," depending on the context.

[0020] FIG. 1 illustrates an exemplary process 100 for confidentially generating a shipping order for one or more clinical trial studies, the shipping order including one or more blinding kits. Process 100 may be performed, for example, using one or more electronic devices implementing a software platform. In some examples, process 100 is performed using a client-server system, with the blocks of process 100 being divided in any manner between a server and a client device. In other examples, the blocks of process 100 are divided between a server and multiple client devices. In other examples, process 100 is performed using only a client device or multiple client devices. In process 100, some blocks are optionally combined, some blocks are optionally reordered, and some blocks are optionally omitted. In some examples, additional steps may be performed in combination with process 100. Accordingly, the operations illustrated (and described in more detail below) are exemplary in nature and, therefore, should not be considered limiting.

[0021] 1, the system may receive, at a first computer system, a plurality of supply orders associated with one or more clinical trials. The plurality of supply orders may be related to a particular clinical trial study associated with a client.

[0022] In one or more examples, the system may receive multiple supply orders from clients via direct communication, such as email, telephone, letter, etc. In one or more examples, the system may receive multiple supply orders via an external system or application. In one or more examples, the external system may be integrated with the system via an application programming interface (API). For example, the external system may be configured to communicate with the system upon receiving multiple supply orders via the API.

[0023] 1, the system can determine clinical trial study and site locations for the plurality of supply orders at a first computer system. In one or more examples, the system can determine additional information associated with the plurality of supply orders.

[0024]

[0013] Figure 2 illustrates exemplary data that may be associated with a supply order. As shown, a supply order may include client data, clinical trial study data, site location data, packaging type, quantity of each packaging type, blinding type, and shipping type. The types of information illustrated in Figure 2 are exemplary, and more or less information may be associated with a supply order without departing from the scope of this disclosure.

[0025] In one or more examples, the client data may indicate the identity of the client that requested the supply order. In one or more examples, the clinical trial study may associate the supply order with a specific clinical trial study. In one or more examples, the clinical trial study may be identified by a number corresponding to the specific clinical trial study. In one or more examples, the site location may correspond to a specific location associated with the clinical trial study that should receive the product requested via the supply order. In one or more examples, the packaging type may indicate a type of material (e.g., drug, drug dose, bottle, syringe, label, etc.). For example, a first packaging type associated with a clinical study may correspond to a first dose of a specific medication provided in a bottle with the first type of label, a second packaging type associated with the same clinical study may correspond to a placebo provided in a bottle with the first type of label, and a third packaging type associated with the clinical study may correspond to a second dose of a specific medication provided in a bottle with the first type of label. One skilled in the art will understand that the number of packaging types, medications, and prescribed dosages will vary based on the parameters of the clinical trial study. In one or more examples, the quantity of kits of each packaging type may indicate how many kits of each packaging type have been ordered. In one or more examples, the blinding type may indicate whether the study is blinded. In one or more examples, the shipping type may refer to pack-to-order shipping or pack-to-stock shipping.

[0026] As an example, a client may be planning a clinical trial to test a particular drug and evaluate the effectiveness and side effects associated with the drug. In such an example, the system may receive multiple supply orders associated with the same clinical trial. The multiple supply orders may be associated with multiple clinical trial site locations where the drug will be distributed to participants in the clinical trial study. In one or more examples, each clinical trial site location may be associated with a different number of kits. For example, a clinical trial study may be associated with locations in Philadelphia, Pennsylvania, and Urbana, Illinois. The Philadelphia location may have a different quantity of kits because the Philadelphia location is expected to have more participants.

[0027] FIG. 3A illustrates an example process 300A associated with blocks 102 and 104. In block 302, the system can receive a supply order 320A, for example, by invoking a supply order web service. In one or more examples, the supply order web service can include an API associated with an external system. As shown in the figure, supply order 320A can include three supply orders, which may be associated with three medication types across the order. For example, a first supply order may be associated with three products of a first packaging type (SO1=PT1x3) and three products of a second packaging type (SO1=PT2x3), a second supply order may be associated with five products of a first packaging type (SO2=PT1x5), and a third supply order may be associated with two products of a first packaging type (SO3=PT1x2) and two products of a second packaging type (SO3=PT3x2). As used herein, a product may refer to a packaged kit intended for distribution to participants in a clinical trial study. An article of manufacture or kit may include a predetermined amount of a particular medication packaged in a predetermined container (e.g., a bottle, a blister pack, a syringe, etc.) with a predetermined label. In one or more examples, a first packaging type may correspond to a first dosage type in a first dosage amount, a second packaging type may correspond to a placebo, and a third packaging type may correspond to the first dosage type in a second dosage amount. For example, the first packaging type may correspond to a 100 mg dose of aspirin, the second packaging type may correspond to a placebo, and the third packaging type may correspond to a 50 mg dose of aspirin. One of ordinary skill in the art will recognize that these medications and dosage amounts are exemplary and that any medications and dosage amounts may be used without departing from the scope of the present disclosure.

[0028] In block 304A, the system may check for errors associated with the received supply order 320A. If an error is detected, the system may communicate with an external system to resolve the error. If no error is detected, the system may determine whether the received supply order 320A is quantity-driven or kit-driven in block 306A. Each kit may be associated with a unique serial identification number. In one or more examples, a quantity-driven order may refer to a supply order in which the client specifies a specific kit quantity and is unconcerned with the unique serial identification number associated with the kit. In one or more examples, a kit-driven supply order may refer to a supply order in which the client specifies a specific serial identification number. If the system determines that the supply order is kit-driven, the system proceeds to block 308A, where the system may match the kit number to a known inventory number. The system may determine whether the kit number is invalid in block 310A. If the number is invalid, the system may flag an error. If the kit number can be matched to a known inventory number, the system may create an aggregated supply order in block 312A. If the system determines that the supply order is quantity driven, the system may proceed to create an aggregated supply order at block 312A.

[0029] Returning to FIG. 1 , at block 106, the system may allocate, at the first computer system, a first plurality of supply orders associated with a first clinical trial study to packaging sites based on site locations. In one or more examples, the first plurality of supply orders may correspond to supply orders associated with multiple site locations within the same country. For example, different countries may have different rules and regulations regarding the provision and packaging of drugs for use in clinical trials. Thus, the first plurality of supply orders for site locations within the same country may be subject to the same packaging requirements. For example, the system may receive multiple supply orders for site locations for a clinical trial study in the United States, Canada, and Japan. In such an example, the first plurality of supply orders may be associated with a clinical trial study located in the United States, the second plurality of supply orders may be associated with a clinical trial study located in Canada, and the third plurality of supply orders may be associated with a clinical trial study located in Japan. In one or more examples, the multiple supply orders may be associated with one or more countries, as permitted by the clinical trial study design.

[0030] In one or more examples, the system may automatically assign a packaging site to the first plurality of supply orders based on the clinical trial site location. In one or more examples, the packaging site may be predetermined based on the country in which the site location is located. In one or more examples, the packaging site may be based on whether the site locations are in the same country. In one or more examples, the packaging site may be based on whether the site locations are in the same region. In one or more examples, the packaging locations may be pre-configured such that a packaging site is automatically assigned when a request from a particular site location is received.

[0031] In one or more examples, supply orders assigned to a packaging site may be placed in an aggregator queue (e.g., as shown in FIG. 4E). In one or more examples, each packaging site may be associated with a different queue. In one or more examples, an operator may manually input into the system which supply orders should be aggregated from the queue. In one or more examples, the system may automatically determine which supply orders should be aggregated from the queue. In one or more examples, a user associated with the system may determine which supply orders should be aggregated from the queue. For example, the system may display a preview of the expected aggregation of assembly and shipping orders (e.g., as shown in FIG. 4F).

[0032] In one or more examples, blocks 108 and 110 are associated with a process for aggregating supply orders in accordance with embodiments of the present disclosure. As described above, traditionally, each supply order is prepared separately. A supply order that includes multiple packaging types may be prepared in multiple packaging runs. For example, each packaging type may be associated with specific packaging, materials, protocols, and requirements; thus, products with different packaging types may be produced in separate packaging runs. When there are multiple supply orders that include multiple packaging types, packaging the supply orders using these methods may be inefficient, costly, and time-consuming. For example, each packaging run may be associated with a separate room setup, room cleaning, and review and release of the packaged product. Thus, a single supply order may be associated with multiple room setups, room cleanings, and review and release of the packaged product.

[0033] 1 , the system may associate a first subgroup of the first plurality of supply orders with a first assembly procedure at a first computer system. In one or more examples, the first subgroup of the first plurality of supply orders may correspond to supply orders that correspond to the same packaging type. For example, with reference to supply order 320A described above with respect to process 300A, the first subgroup of the first plurality of supply orders may correspond to a first packaging type. With reference to supply order 320A, the first subgroup may correspond to three products of packaging type 1 (SO1=PTx3) from the first supply order, five products of packaging type 1 (SO2=PTx5) from the second supply order, and two products of packaging type 1 (SO3=PTx2) from the third supply order.

[0034] 1 , the system may associate, at the first computer system, a second subgroup of the first plurality of supply orders with a second assembly procedure. For example, with reference to supply order 320A, the second subgroup of the first plurality of supply orders may correspond to a second packaging type. According to this example, the second subgroup may correspond to three products of packaging type 3 of the first supply order.

[0035] To the extent that process 100 includes generating first and second assembly orders, those skilled in the art will understand that the number of assembly orders generated is not intended to limit the scope of the present disclosure. More or fewer assembly orders may be generated based on the parameters of a particular clinical trial study. For example, with reference to supply order 320A, the method may further include associating a third subgroup of the first plurality of supply orders with a third assembly procedure.

[0036] For example, referring to supply order 320A, packaging three supply orders according to this method results in five separate packaging runs: two packaging runs associated with the first supply order, e.g., a first packaging run for the first packaging type (SO1 = PT1x3) and a second packaging run for the second packaging type (SO1 = PT2x3); one packaging run for the second supply order associated with the first packaging type (SO2 = PT1x5); and two additional packaging runs for the third supply order, e.g., a first packaging run for two orders of the first packaging type (SO3 = PT1x2) and a second packaging run for two orders of the second packaging type (SO3 = PT3x2). Each packaging run may be associated with a separate room setup, separate room set cleanup, separate review of the packaged products, and separate release of the packaged products. The time associated with performing these separate tasks can increase costs and time burdens and lead to increased inefficiencies.

[0037] FIG. 3B illustrates an exemplary aggregated order 300B according to an embodiment of the present disclosure. As shown, aggregated order 300B may include one or more supply orders 322B, one or more assembly orders 324B, and one or more shipping orders 326B. In one or more examples, FIG. 3B may be associated with blocks 108 and 110. As shown, embodiments of the present disclosure may reduce the number of packaging runs by aggregating orders associated with the same packaging type. For example, orders with the same packaging type may be associated with kits containing the same type of drug, the same amount of drug, and similar packaging. Accordingly, these orders with the same packaging type may be associated with the same protocol (e.g., because at least the packaging type is for the same study within the same country). Aggregating orders in this manner may improve packaging efficiency by reducing the number of packaging runs and associated overhead (e.g., individual batch record creation, room setup, room cleaning, review, and release, etc.).

[0038] Aggregate order 300B may correspond to an exemplary order aggregation of supply order 320A. For example, supply order 322B may correspond to supply order 320A, and the supply orders may be associated with different site locations and one or more packaging types. The site locations may be in the same country. For example, a first supply order may be associated with three products of a first packaging type (SO1=PT1x3) and three products of a second packaging type (SO1=PT2x3), a second supply order may be associated with five products of the first packaging type (SO2=PT1x5), and a third supply order may be associated with two products of the first packaging type (SO3=PT1x2) and two products of the second packaging type (SO3=PT3x2).

[0039] Assembly order 324B in FIG. 3B illustrates the aggregation of supply orders based on packaging type. For example, as shown, packaging type 1 is associated with assembly order 1, packaging type 2 is associated with assembly order 2, and packaging type 3 is associated with assembly order 3. Accordingly, embodiments of the present disclosure can reduce the number of packaging runs associated with these three supply orders from five separate runs associated with traditional packaging methods to three runs. Those skilled in the art will appreciate that these efficiency gains become even more pronounced as the number of supply orders increases.

[0040] The number of supply orders 322B is the same as the number of assembly orders 324B, although one skilled in the art would understand that the number of supply orders may differ from the number of assembly orders based on the packaging types included in the supply orders selected for aggregation.

[0041] Shipping orders 326B in Figure 3B illustrate how the system breaks down assembly orders into shipping orders based on supply orders. For example, once packaged, products may be allocated based on the original supply order 320A. As shown in the figure, Shipping Order 1 may correspond to Supply Order 1, with the same quantity of products in various packaging types. For example, Shipping Order 1 and Supply Order 1 may include three products in a first packaging type and three products in a second packaging type. As shown in the figure, Shipping Order 2 may correspond to Supply Order 2, and Shipping Order 3 may correspond to Supply Order 3.

[0042] 3C illustrates an example process 300C associated with blocks 108 and 110. In block 302C, the system can create assembly orders based on packaging types. In block 304C, the system can create shipping orders based on supply orders, with one shipping order associated with each site location that submitted a supply order. Blocks 302C and 304C can be associated with aggregate order 300B described above.

[0043] In one or more examples, the system can display the aggregate preview based on blocks 302C and 304C. In one or more examples, the system can confirm or receive the aggregate preview. Once confirmed, the system can aggregate the supply orders to generate assembly orders and shipping orders. As part of each new aggregated order, the system can generate three ID types: a single aggregate order ID assigned to the aggregation, an assembly order ID for each assembly order grouped by packaging type, and a shipping order ID for each shipping order grouped by site and shipping group.

[0044] Once the assembly and shipping orders are created, the system may change the aggregator order status to new in block 306C. This status change may indicate to the system that the assembly order is ready for review before sending to the packaging site. For example, the system may check the availability of packaging materials (e.g., medications, bottles, blister packs, labels, etc.) at the packaging site. In block 308C, the system may input a labeled lot number and expiration date. In one or more examples, the labeled lot number may be received from an external system via an API.

[0045] In block 310C, the system may verify or modify the labeled lot number and expiration date of the aggregate order. In one or more examples, after the lot number and expiration date are assigned, the system may then mark the aggregate order as planned.

[0046] In block 312C, the system may determine whether the labeled lot number and expiration date are approved. If the labeled lot number and expiration date are not approved, the system may modify the assembly order by waiting for approval or deleting one or more supply orders associated with the assembly order in block 314C. If the labeled lot number and expiration date are approved, the system may display the material quantity for the approved labeled lot number from the external integration system in block 316C. In block 318C, the system may check to determine whether materials for packaging the assembly order are available. In one or more examples, the system may verify the availability of packaging materials (e.g., medications, bottles, blister packs, labels, etc.) at the packaging site. The system may then mark the aggregate order as planned in block 320C.

[0047] FIG. 3D illustrates an exemplary process 300D executed by a first computer system and associated with creating an aggregate order (e.g., an aggregator system). Process 300D is a continuation of process 300C. When the aggregate order status is sent to planned, the system may first assign a lot identifier and an expiration date in block 304D and save the order in block 306D. In one or more examples, the system may send a notification to a second computer system associated with the packaging site that the newly created aggregate order has been assigned to the packaging site. In such an example, one or more users associated with the second computer system at the packaging site may review the aggregate order, verify the availability of packaging materials at the packaging site, plan the packaging execution, and assign each assembly order to the packaging relative to the originally assigned lot identifier and expiration date. In one or more examples, the lot identifier may be updated based on client preferences; for example, the client may specify a preferred lot identifier. Once all assembly orders have been assigned, the aggregate order is marked as committed in block 308D.

[0048] In one or more examples, the committed aggregate order can initiate an external process that creates a work order and an actionable batch record, which is then used by a quality assurance operator user to review each assembly order and mark it as approved for packaging in block 314D. In one or more examples, the quality assurance operator can ensure that the lot identifiers correspond to the client-specified lot identifiers.

[0049] Once the assembly order is approved in block 310D, the aggregate order is marked as approved for packaging.

[0050] In one or more examples, a quality assurance operator can approve or reject each assembly order and perform lot release in block 312D. As part of lot release, the system can verify the medication identifier, each serialized assembly order, and the usage sequence printed on the shipping order from an external system. After all assembly orders are packaged / rejected, the system can receive an indication as to whether the aggregate order was packaged or rejected. In one or more examples, rejected aggregate orders can be handled via a manual process separate from the system.

[0051] 1, the system may receive the first assembly order and the second assembly order at a second computer system. In one or more examples, the second computer system may be associated with a packaging facility for packaging the assembly orders. In this manner, a first plurality of supply orders associated with the same clinical trial and site location within the same country may be packaged at the same packaging facility.

[0052] At block 114 of FIG. 1 , the system can randomly assign multiple kit identifiers to the first assembly order and the second assembly order at a second computer system, thereby creating multiple blinded kits. In one or more embodiments, randomly assigning the multiple kit identifiers can include assigning a selected range of pre-randomized kit identifiers. In such embodiments, numbers corresponding to the pre-randomized kit identifiers can be selected without knowing the drug type represented by the kit identifier. The assembly orders can be packaged based on this randomization. In one or more examples, a second computer system associated with the packaging site can access a randomization list to determine which kits are associated with an active drug or a placebo, while the first computer system may not have access to this randomization list. In this way, the system can package the original supply order in a covert manner and suppress access to the randomization information from a first computer system (e.g., associated with aggregating the supply orders), thereby reducing the likelihood that the study will be unblinded.

[0053] In one or more examples, the kit identifiers may be designated by a customer, e.g., an individual associated with a clinical trial study. For example, the system may receive input at a first computer system from a customer associated with the first clinical trial study, the input including updated kit identifiers for one or more of the first plurality of supply orders. The system may then update the plurality of kit identifiers associated with the first plurality of supply orders. This kit identifier update may be completed before assigning the plurality of kit identifiers to the first assembly order and the second assembly order in block 114.

[0054] FIG. 3E illustrates an example process 300E associated with block 114. The blocks associated with process 300E may be performed on a second computer system associated with the packaging site. In block 302E, the second computer system may randomize the kit identifiers based on packaging type, for example, by associating the kit identifiers with an active packaging type or a control (e.g., placebo) packaging type. In one or more examples, the active packaging type may be associated with a first packaging type, and the control packaging type may be associated with a second, different packaging type. In one or more examples, the kit identifiers may be obtained from the first computer system. In one or more examples, the randomization list associating the kit identifiers with active or placebo packaging types may be maintained on the second computer system and not shared with the first computer system. In one or more examples, the second computer system may be external to the first computer system.

[0055] At block 304E, the system may execute the scan assembly order. In one or more examples, the scan assembly order may be executed by an external scan assembly system. The scan assembly system may be configured to validate the selected kit IDs and provide control and traceability of the movement of the kits. In some examples, the scan assembly system may communicate with a first computer system (e.g., an aggregator system). At block 306E, the system may create a master packout. In one or more examples, data associated with the assembly order at the first computer system is communicated to the scan assembly system to create the master packout. In one or more examples, at block 308E, the system may associate packaging operations (e.g., corresponding to the assembly order) with the master packout operation. For example, the scan assembly system may receive reference labels and individual kit IDs from the first computer system, and the scan assembly system may manage the packaging of the shipments so that the kit IDs are matched to the correct shipments. In one or more examples, at block 310E, the system may create child packout operations. A child packout operation may refer to the packaging of each medication type; for example, as described above, one medication may be present in the packaging room at a time. For a child packout operation, the system may determine whether the supply order is quantity-driven or kit-driven in block 312E. If the supply order is quantity-driven, the system may determine the quantity of the material type from the assembly operation in block 314E. If the supply order is kit-driven, the system may obtain aggregate order details including material identifiers from the first computer system. In block 318E, the system may execute the packout operation.

[0056] In block 116 of FIG. 1 , the system can covertly generate shipping orders for a first plurality of clinical trials at a first computer system based on the plurality of blinded kits. For example, the system can decompose assembly orders into shipping orders 326B based on received supply orders 322B, as described above with respect to aggregated order 300B. For example, each shipping order may be associated with a single site location and include kits packaged based on one or more assembly orders. Because randomization information is maintained at a second computer system, as previously described, shipping orders can be generated covertly to prevent, for example, unblinding of the study. In this manner, embodiments of the present disclosure provide improved security in preparing supply orders for clinical trial studies in addition to the improved packaging efficiency provided by aggregating supply orders.

[0057] In one or more examples, the system may receive an indication that a packout operation has been performed and the assembly order has been packaged. In one or more examples, the second system may communicate to the first system that the assembly order has been packaged. In one or more examples, the system may first perform a quality assurance check of the packaged assembly order. If the assembly order does not pass the quality assurance check, the assembly order may be flagged for manual review and / or a shipping process. After the quality assurance check, lot release may occur. Lot release may verify material identifiers, usage sequences printed on each assembly order, and usage sequences for shipping orders from an external system or application.

[0058] Embodiments of the present disclosure further provide the flexibility to implement both pack-to-order and pack-to-stock shipment types. Pack-to-order, as used herein, may refer to a supply order that is received by the system and then to be shipped to a designated site location associated with a clinical trial. Pack-to-stock, as used herein, may refer to a supply order that is received by the system and then to be stored at a facility (e.g., a packaging facility or designated warehouse) and shipped to a site location at a later date. In one or more examples, the site location associated with a pack-to-stock shipment type may be unknown at the time the supply order is placed.

[0059] In one or more examples, the system can determine, in a first computer system, a shipping type for a first supply order from a first plurality of supply orders. If the supply order is associated with a pack-to-order shipping type, the first system can generate the shipping order as described above. For example, the first shipping order can be generated confidentially based on the plurality of blinded kits. The packaged kits associated with the first shipping order are then shipped to the appropriate clinical trial site location.

[0060] If the supply order is associated with a pack-to-stock shipment type, the first computer system can generate instructions for storing the kits generated based on the supply order. The kits can be stored at a packaging facility or a warehouse facility. Later, the first computer system may receive a request for the materials associated with the supply order from the first clinical trial site. In such an example, the system can generate a shipping order for the supply order based on the request from the clinical trial site location. In this way, the customer can keep a certain amount of packaged material in reserve. This allows the customer more flexibility to reach additional participants in the clinical trial study by utilizing pre-packaged materials without having to go through a new packaging run.

[0061] In one or more examples, embodiments of the present disclosure may provide systems and methods for aggregating supply orders associated with clinical trial site locations into assembly orders based on one or more treatment types (e.g., packaging types). Kits generated via assembly orders may be split into one or more shipping orders based on the supply orders. In one or more examples, the aggregation process may include at least a planning phase, a post-production phase, and a shipping phase. These phases may be associated with one or more blocks described above with respect to process 100.

[0062] In one or more examples, as part of the planning stage, the system may receive multiple supply orders from an external system or application, for example, when the external system discovers site demand or when the system receives a direct request from a site location associated with a client. In one or more examples, the system may automatically assign packaging locations to these supply orders based on the destination location. In one or more examples, the packaging locations may be based on whether the site locations are in the same country. In one or more examples, the packaging locations may be based on whether the site locations are in the same region. In one or more examples, the packaging locations may be pre-configured such that a packaging location is automatically assigned when a request from a particular site location is received.

[0063] In one or more examples, supply orders assigned to a packaging site may be placed in an aggregator queue (e.g., as shown in FIG. 4E). In one or more examples, each packaging site may be associated with a different queue. In one or more examples, the system may automatically determine which supply orders should be aggregated from the queue. In one or more examples, a user associated with the system may determine which supply orders should be aggregated from the queue. For example, the system may display a preview of the expected aggregation of assembly and shipping orders (e.g., as shown in FIG. 4F).

[0064] The system can confirm or receive the aggregate preview. Once confirmed, the system can aggregate the supply orders to generate assembly and shipping orders. As part of each new aggregated order, the system can generate three types of IDs: a single aggregate order ID assigned to the aggregate, an assembly order ID for each assembly order grouped by packaging type, and a shipping order ID for each shipping order grouped by site and shipping group.

[0065] In one or more examples, the system can verify the availability of packaging materials (e.g., medications, bottles, blister packs, labels, etc.) at the packaging site. The system can also initially assign a lot identifier and an expiration date. The system can then mark the aggregate order as planned. Once planned, the system can send a notification to a second computer system associated with the packaging site that the newly created aggregate order has been assigned to the packaging site. In such an example, one or more users associated with the second computer system at the packaging site can review the aggregate order, verify the availability of packaging materials at the packaging site, plan the packaging execution, and assign each assembly order to the packaging against the originally assigned lot ID and expiration date. In one or more examples, the lot identifiers can be updated based on client preferences; for example, the client can specify a preferred lot identifier. Once all assembly orders are assigned, the aggregate order is marked as committed.

[0066] In one or more examples, the committed aggregate order can initiate an external process that creates a work order and an actionable batch record, which is then used by a quality assurance operator user to review each assembly order and mark it as approved for packaging. In one or more examples, the quality assurance operator can ensure that the lot identifier corresponds to a client-specified lot identifier. Once the assembly order is approved, the aggregate order is marked as approved for packaging. In one or more examples, the aggregate order may contain only accessories. In such an example, the aggregate order would proceed directly to post-production without any planning activities.

[0067] In one or more examples, as part of the post-manufacturing phase, a quality assurance operator can approve or reject each assembly order and perform lot release. As part of lot release, the system can verify the medication identifier, each serialized assembly order, and the usage sequence printed on the shipping order from an external system. After all assembly orders are packaged / rejected, the system can receive an indication as to whether the aggregate order was packaged or rejected. In one or more examples, rejected aggregate orders can be handled via a manual process separate from the system.

[0068] In one or more examples, the system may receive an indication of whether a sublot is part of an aggregate order. In one or more examples, a sublot may refer to a non-manufactured purchased item (e.g., syringes, alcohol-based wipes) included in an order. These sublots may be considered generic and non-unique.

[0069] In one or more examples, once the assembly order is packaged and supporting information is entered, the shipping order may be ready for pre-distribution. In one or more examples, as part of the shipping stage, the system may mark the aggregated order as approved for shipment and generate a shipping plan for each shipping order in the aggregate that has a shipping type of pack-to-order (PTO). No shipping plan is created for pack-to-stock (PTS) shipping types. PTS orders are packaged and stored in a packaging facility or warehouse.

[0070] In one or more examples, the system can receive a shipping order message from an external system at a second computer system associated with the packaging site. The system can initiate a shipping process and update the status of the shipping order associated with the aggregated order to a sent status. If an error occurs in the shipping process, the system may flag the shipment for manual review before notifying the external system. The system can receive verification from one or more external systems that the product shipment has been shipped or delivered and update the aggregated order status accordingly.

[0071] 4A-4J illustrate exemplary user interfaces according to embodiments of the present disclosure.

[0072] 4A shows an exemplary user interface 400A corresponding to a login screen of a first computer system. In one or more examples, a user associated with the first computer system may be prompted to log in to the first computer system via user interface 400A. As shown in the figure, user interface 400A may include one or more user affordances for receiving a username and password from the user. The user interface may further include a user affordance (e.g., a login button) for the user to log in to the first computer system by providing a username and password.

[0073] 4B illustrates an exemplary user interface 400B corresponding to a landing page of a first computer system. For example, the exemplary user interface 400B may be presented to a user upon successful login. The user interface 400B may include multiple user affordances for navigating to different sections of the first computer system. For example, the user interface 400B includes an affordance for an aggregator user, an affordance for an administrator user, and an affordance for a scan assembly user. The user interface 400B may further include a summary of past login attempts by the user. This may be provided as a security measure to ensure that the user's account has not recently been accessed unauthorizedly.

[0074] 4C shows an example user interface 400C corresponding to an administration page of the first computer system. As shown, the administration page may include a navigation bar that allows navigation to one or more user interfaces associated with users, external systems and programs, projects, and audit trails.

[0075] FIG. 4D illustrates an exemplary user interface 400D corresponding to an exemplary aggregator page of a first computer system. As illustrated, the aggregator page 400D may be associated with a queue section. The queue section may be adapted to display one or more queued supply orders. For example, queued supply orders may be displayed based on selected criteria, including client, project (e.g., clinical trial study), destination country, order type (e.g., initial, regular, urgent), and / or text search. An initial order, as used herein, may refer to a first order for a site. A regular order, as used herein, may refer to a standard order for a site that may be fulfilled with a standard lead time. An urgent order, as used herein, may correspond to an order that requires response and completion more quickly than the standard lead time. Each of these items may be selected based on a drop-down menu, or in the case of a text search, the system may receive text via a user affordance. Based on the selected information, queued supply orders may be displayed on the aggregator page 400D.

[0076] In one or more examples, the user interface may be adapted to display information related to queued supply orders, such as a supply order identifier, material type (e.g., drug and dosage, packaging material, label material, etc.), when the supply order was received, destination site (e.g., where the supply order is to be shipped), and requested delivery date. In one or more examples, the information displayed in the queued order list may be based on selected criteria. For example, if a destination country is selected, the destination country may be omitted from the displayed information in the queued order list (e.g., the column corresponding to the destination country may be omitted). This may avoid displaying redundant information, reducing clutter in the user interface and improving visibility.

[0077] 4E illustrates an example user interface 400E corresponding to an example aggregator page of a first computer system. As shown, the aggregator page 400E may be associated with a queue section, where the system is receiving information related to a selected client, project (e.g., clinical trial study), destination country, and order type (e.g., initial, regular, urgent). As shown, the system can display orders with multiple queue states based on the received information. As shown, multiple supply orders may be associated with the same destination site and / or material type.

[0078] For example, supply order ID 01-0079 placed on June 4, 2022, might be associated with material type 3 and correspond to a requested quantity of 32 to be shipped to destination site 16; supply order ID 01-0074 placed on June 4, 2022, might be associated with material type 3 and correspond to a requested quantity of 13 to be shipped to destination site 6; supply order ID 01-0073 placed on June 4, 2022, might be associated with material type 3 and correspond to a requested quantity of 19 to be shipped to destination site 5; supply order ID 01-0072 placed on June 4, 2022, might be associated with material type 3 and correspond to a requested quantity of 9 to be shipped to destination site 4; supply order ID 01-0072 placed on May 26, 2022, might be associated with material type 3 and correspond to a requested quantity of 25 to be shipped to destination site 6; supply order ID 01-0074 placed on June 4, 2022, might be associated with material type 3 and correspond to a requested quantity of 13 to be shipped to destination site 6; supply order ID 01-0073 placed on June 4, 2022, might be associated with material type 3 and correspond to a requested quantity of 19 to be shipped to destination site 5; supply order ID 01-0072 placed on May 26, 2022, might be associated with material type 3 and correspond to a requested quantity of 25 to be shipped to destination site 6; Supply order ID 01-0066 placed on May 25, 2022 may correspond to a requested quantity of 13 associated with the same material type 3 and to be shipped to destination site 5; supply order ID 01-0068 placed on May 25, 2022 may correspond to a requested quantity of 9 associated with the same material type 3 and to be shipped to destination site 4; and supply order ID 01-0066 placed on May 24, 2022 may correspond to a requested quantity of 13 associated with the same material type 3 and to be shipped to destination site 4. According to embodiments of the present disclosure, because these supply orders listed above correspond to the same material type (e.g., packaging type), same client, same clinical trial study, and same destination country, the system can aggregate these orders for packaging, whereas previous systems may have generated separate packaging runs for each order.

[0079] Although the client, project, destination country, and order type fields are selected in user interface 400E, in one or more examples, more or fewer fields may be utilized to display the list of queued supply orders. For example, the system may display queued supply orders based on client and project.

[0080] FIG. 4F illustrates an exemplary user interface 400F corresponding to an exemplary aggregator page of a first computer system. As shown in the figure, the aggregator page 400F may be associated with an aggregate preview. The aggregate preview may include an assembly order section displaying lists corresponding to different assembly orders and a shipping order section displaying lists corresponding to different shipping orders. In one or more examples, the system can receive a selection of one or more supply orders listed in the queue shown in user interface 400E. For example, user interface 400F may be based on a selection of supply order IDs 01-0081 and 01-0079 shown in user interface 400E. As shown in the figure, the user interface may provide user affordances for confirming or canceling the displayed aggregate preview. Confirming the aggregate preview can remove the corresponding supply orders from the queue.

[0081] Referring to user interface 400F, the assembly order section may include information regarding the type of study (e.g., blinded or unblinded), material type (e.g., packaging type), material description (e.g., drug and dosage), and kit identifier. As shown, the assembly order associated with material type 3 is shown as a blinded study, although unblinding information may not be displayed or accessible to the user via user interface 400F.

[0082] The shipping order section may include information regarding the destination site, replenishment type (e.g., pack-to-order or pack-to-ship), shipping group, finished product quantity, and kit identifier. In one or more examples, the shipping order information may be based on the supply order information.

[0083] FIG. 4G illustrates an exemplary user interface 400G corresponding to an exemplary aggregator page of a first computer system. User interface 400G may be associated with a supply order page. As shown in the figure, user interface 400G may display a list of supply orders. The list of supply orders may be displayed based on a selected client, project (e.g., clinical trial study), destination country, order type (e.g., initial, regular, urgent), order status (e.g., queued, new, planned), and / or text input received from a user. The supply order list may be displayed based on one or more of these parameters. For each supply order included in the list, user interface 400G may display, but is not limited to, a supply order identifier, an order status, an aggregated order identifier, the date the supply order was received, the client's name, the project (e.g., clinical trial study), the source (e.g., whether the order was received through an application or through direct communication with the customer), the requested delivery date, the destination site, and the destination country. As shown in user interface 400G, the supply order list corresponds to a selection of an order type and an order status. In one or more examples, the information displayed in the queued orders list may be based on the selected criteria. For example, if a destination country is not selected, the displayed information may include the destination country in the queued orders list (e.g., the column corresponding to the destination country may be omitted), as shown in user interface 400G. This may reduce clutter in the user interface and improve visibility.

[0084] 4H shows an exemplary user interface 400H corresponding to an exemplary aggregator page of the first computer system. User interface 400H may correspond to a supply order details page associated with selection of a particular supply order (e.g., supply order identifier: 01-0033) from a supply order page (e.g., user interface 400G). As shown in user interface 400H, the supply order details page may display information associated with the supply order, including, but not limited to, order status, date the supply order was received, client name, project (e.g., clinical trial study), source (e.g., whether the order was received through an application or through direct communication with the customer), client protocol identifier, packaging hub location including country and city (e.g., where the supply order will be packaged), requested delivery date, destination site, and destination country. User interface 400H may also display shipping details, including a shipping address and shipping instructions. User interface 400H may also display finished product information, including, but not limited to, study type (e.g., blinded or unblinded), replenishment type (e.g., pack-to-order and pack-to-stock), material type, material description, quantity, assembly order ID, and shipping order ID. User interface 400H may also include information regarding ancillary supplies associated with the supply order. Those skilled in the art will appreciate that these user interfaces are exemplary and may include more or less information without departing from the scope of the present disclosure.

[0085] FIG. 4I illustrates an exemplary user interface 400I corresponding to an exemplary aggregated orders page of a first computer system. The user interface 400I can display a list of aggregated orders based on one or more selection criteria. As shown, the one or more selection criteria may include client, project, destination country, order status, or text search. The aggregated orders may correspond to one or more aggregated orders described above with respect to blocks 108 and 110 and FIGS. 3B and 3C. The information displayed for each aggregated order includes, but is not limited to, an aggregated order identifier, order status, aggregation date, client, project (e.g., clinical trial study), destination country, one or more supply orders comprising the aggregated order, and requested delivery date. In one or more examples, the information displayed in the queued order list may be based on the selected criteria. For example, if no destination country is selected, the displayed information may include the destination country in the queued order list (e.g., the column corresponding to the destination country may be omitted), as shown in user interface 400I.

[0086] FIG. 4J illustrates an exemplary user interface 400J corresponding to an exemplary aggregate order page of the first computer system. The user interface 400J corresponds to a detail page associated with a particular aggregate order, e.g., aggregate order AG-218. As shown in the figure, the aggregate order detail page may include general information related to the aggregate order, including, but not limited to, the client, order status (e.g., packaged, planned, queued, new, shipped), aggregation date, project (e.g., clinical trial study), requested delivery date, client protocol number, destination country, and packaging hub (including city and country). The user interface 400J may further include details about the shipping order. In one or more examples, the shipping order may correspond to the shipping order described above with respect to blocks 116 and 326B. For example, the shipping order may correspond to a disassembled assembly order. The user interface 400J may display information including, but not limited to, a shipping order identifier, a destination site, a replenishment type, a shipping group, a finished product quantity, a kit identifier, an auxiliary product quantity, a supply order number, and an order status. The user interface 400J may further include one or more comments, which may identify the user who posted the comment, the date corresponding to when the comment was posted, in addition to the comment itself.

[0087] Those skilled in the art will appreciate that these user interfaces are exemplary and may include more or less information without departing from the scope of the present disclosure. Additionally, different display configurations may be used without departing from the scope of the present disclosure.

[0088] The operations described above with reference to the preceding figures are optionally implemented by the components shown in Figure 5. It will be apparent to those skilled in the art how other processes may be implemented based on the components shown in Figure 5.

[0089] FIG. 5 illustrates an example of a computing device, according to one embodiment. Device 500 may be a host computer connected to a network. Device 500 may be a client computer or a server. As illustrated in FIG. 5, device 500 may be any suitable type of microprocessor-based device, such as a personal computer, a workstation, a server, or a handheld computing device (portable electronic device) such as a phone or tablet. The device may include, for example, one or more of a processor 510, an input device 520, an output device 530, storage 540, and a communication device 560. Input device 520 and output device 530 may generally correspond to those described above and may be connectable to or integrated into the computer.

[0090] The input device 520 may be any suitable device that provides input, such as a touchscreen, a keyboard or keypad, a mouse, or a voice recognition device. The output device 530 may be any suitable device that provides output, such as a touchscreen, a haptic device, a speaker, etc.

[0091] Storage 540 may be any suitable device providing storage, such as RAM, cache, electrical, magnetic, or optical memory, including a hard drive or removable storage disk. Communication device 560 may include any suitable device capable of sending and receiving signals over a network, such as a network interface chip or device. The components of a computer may be connected in any suitable manner, such as via a physical bus or wirelessly.

[0092] Software 550 that may be stored in storage 540 and executed by processor 510 may include, for example, programming that embodies functions of the present disclosure (e.g., as embodied in a device such as those described above).

[0093] The software 550 may also be stored and / or carried in any non-transitory computer-readable storage medium from which instructions associated with the software can be fetched and executed for use by or in connection with an instruction execution system, apparatus, or device, such as those described above. In the context of this specification, a computer-readable storage medium may be any medium, such as storage 540, that contains or can store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0094] The software 550 may be propagated in any transport medium capable of fetching instructions associated with the software from and executing the instructions for use by or in connection with an instruction execution system, apparatus, or device such as those described above. In the context of this specification, a transport medium may be any medium capable of communicating, propagating, or transporting a program for use by or in connection with an instruction execution system, apparatus, or device. Transport media may include, but are not limited to, electronic, magnetic, optical, electromagnetic, and infrared wired or wireless propagation media.

[0095] The device 500 may be connected to a network, which may be any suitable type of interconnected communication system. The network may implement any suitable communication protocol and may be protected by any suitable security protocol. The network may include any suitable arrangement of network links capable of transmitting and receiving network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, telephone lines, etc.

[0096] Device 500 may implement any operating system suitable for operating on a network. Software 550 may be written in any suitable programming language, such as C, C++, Java, or Python. In various embodiments, application software embodying functionality of the present disclosure may be deployed in a variety of configurations, such as, for example, in a client / server configuration or as a web-based application or web service via a web browser.

[0097]

[0006] Embodiments of the present disclosure provide a method for covertly generating shipping orders for clinical trials. In one or more examples, the method includes receiving, at a first computer system including one or more processors and one or more memories, a plurality of supply orders associated with one or more clinical trials; determining a clinical trial study, a site location, and a treatment type for each of the plurality of supply orders; and allocating the first plurality of supply orders associated with the first clinical trial study to a packaging site based on the site location. In one or more examples, the method further includes associating a first subgroup of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order, and associating a second subgroup of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order. In one or more examples, the method further includes receiving, at a second computer system including a second one or more processors and a second one or more memories, the first assembly order and the second assembly order, and creating a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order. In one or more examples, the method further includes secretly generating, at the first computer system, shipping orders for the first plurality of clinical trials based on the plurality of blinded kits.

[0098] In some embodiments, the first treatment type corresponds to an active group and the second treatment type corresponds to a control group. In some embodiments, the method further includes, at a first computer system, determining a shipment type for a first plurality of supply orders; generating a shipment order for one or more supply orders associated with the first shipment type in accordance with determining that one or more supply orders are associated with the first shipment type; and generating instructions for storing one or more supply orders associated with the second shipment type in accordance with determining that one or more supply orders are associated with the second shipment type. In some embodiments, the first shipment type corresponds to a request for pack-to-order and the second shipment type corresponds to a request for pack-to-stock. In some embodiments, the method further includes receiving a request from a first clinical trial site associated with the first supply order for one or more supply orders associated with the second shipment type; and generating a shipment order for the first supply order based on the request from the first clinical trial site.

[0099] In some embodiments, the determined site locations of the first plurality of supply orders are associated with the same country. In some embodiments, the plurality of supply orders are received via communication with a customer or an application programming interface associated with a client.

[0100] In some embodiments, the method further includes receiving, at the first computer system, input from a client associated with the first clinical trial study corresponding to updated kit identifiers for one or more of the first plurality of supply orders, and updating the plurality of kit identifiers associated with the first plurality of supply orders. In some embodiments, the updating of the plurality of kit identifiers is performed before assigning the plurality of kit identifiers to the first assembly order and the second assembly order.

[0101] In some embodiments, the method further includes receiving, at the first computer system, a rejection of the first assembly order, the second assembly order, or a combination thereof from a user associated with the first computer system, and flagging the rejected assembly order for a manual shipping process.

[0102] In one or more examples, embodiments of the present disclosure include an electronic system including one or more processors, a memory, and one or more programs, the one or more programs stored in the memory and configured to be executed by the one or more processors. In one or more examples, the one or more programs further include instructions, at a first computer system including the one or more processors and the one or more memories, for receiving a plurality of supply orders associated with one or more clinical trials, determining a clinical trial study, a site location, and a therapy type for each of the plurality of supply orders, and allocating the first plurality of supply orders associated with the first clinical trial study to packaging sites based on the site location. In one or more examples, the one or more programs further include instructions for associating a first subgroup of the first plurality of supply orders with a first assembly procedure based on the therapy type to create a first assembly order, and associating a second subgroup of the first plurality of supply orders with a second assembly procedure based on the therapy type to create a second assembly order. In one or more examples, the one or more programs include instructions, at a second computer system including a second one or more processors and a second one or more memories, for receiving the first assembly order and the second assembly order and creating a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order. In one or more examples, the one or more programs include instructions, at the first computer system, for covertly generating shipping orders for the first plurality of clinical trials based on the plurality of blinded kits.

[0103] In some embodiments, the first treatment type corresponds to an active group and the second treatment type corresponds to a control group. In some embodiments, the one or more programs further include instructions, at the first computer system, for: determining a shipment type for a first plurality of supply orders; generating a shipment order for one or more supply orders associated with the first shipment type in accordance with determining that one or more supply orders are associated with the first shipment type; and generating instructions for storing one or more supply orders associated with the second shipment type in accordance with determining that one or more supply orders are associated with the second shipment type. In some embodiments, the first shipment type corresponds to a request for pack-to-order and the second shipment type corresponds to a request for pack-to-stock. In some embodiments, the one or more programs further include instructions, at the first computer system, for receiving a request from a first clinical trial site associated with the first supply order for one or more supply orders associated with the second shipment type; and generating a shipment order for the first supply order based on the request from the first clinical trial site.

[0104] In some embodiments, the determined site locations of the first plurality of supply orders are associated with the same country. In some embodiments, the plurality of supply orders are received via communication with a customer or an application programming interface associated with a client.

[0105] In some embodiments, the one or more programs further include instructions for receiving, at the first computer system, input from a client associated with the first clinical trial study corresponding to updated kit identifiers for one or more of the first plurality of supply orders, and updating the plurality of kit identifiers associated with the first plurality of supply orders. In some embodiments, updating the plurality of kit identifiers is performed before assigning the plurality of kit identifiers to the first assembly order and the second assembly order.

[0106] In some embodiments, the one or more programs further include instructions at the first computer system for receiving, from a user associated with the first computer system, a rejection of the first assembly order, the second assembly order, or a combination thereof, and flagging the rejected assembly order for a manual shipping process.

[0107] In one or more examples, embodiments of the present disclosure further include a non-transitory computer-readable storage medium storing one or more programs, the one or more programs including instructions that, when executed by one or more processors of one or more electronic devices having a display, cause the one or more electronic devices to: receive, at a first computer system including one or more processors and one or more memories, a plurality of supply orders associated with one or more clinical trials; determine, for each of the plurality of supply orders, a clinical trial study, a site location, and a treatment type; and assign the first plurality of supply orders associated with the first clinical trial study to packaging sites based on the site location. In one or more examples, the one or more electronic devices are further caused to associate a first subgroup of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order, and to associate a second subgroup of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order. In one or more examples, the one or more electronic devices are further caused to receive, at a second computer system including a second one or more processors and a second one or more memories, the first assembly order and the second assembly order, and to create a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order. In one or more examples, the one or more electronic devices are further caused to confidentially generate, at the first computer system, shipping orders for the first plurality of clinical trials based on the plurality of blinded kits.

[0108] In some embodiments, the first treatment type corresponds to an active group and the second treatment type corresponds to a control group. In some embodiments, the one or more electronic devices are further caused to: determine, at the first computer system, a shipment type for a first plurality of supply orders; generate a shipment order for one or more supply orders associated with the first shipment type in accordance with determining that one or more supply orders are associated with the first shipment type; and generate instructions for storing one or more supply orders associated with the second shipment type in accordance with determining that one or more supply orders are associated with the second shipment type. In some embodiments, the first shipment type corresponds to a request for pack-to-order and the second shipment type corresponds to a request for pack-to-stock. In some embodiments, the one or more electronic devices are further caused to: receive, at the first computer system, a request from a first clinical trial site associated with the first supply order for one or more supply orders associated with the second shipment type; and generate a shipment order for the first supply order associated with the second shipment type based on the request from the first clinical trial site.

[0109] In some embodiments, the determined site locations of the first plurality of supply orders are associated with the same country. In some embodiments, the plurality of supply orders are received via communication with a customer or an application programming interface associated with a client.

[0110] In some embodiments, the one or more electronic devices are further caused to receive, at the first computer system, input from a client associated with the first clinical trial study corresponding to updated kit identifiers for one or more of the first plurality of supply orders, and update the plurality of kit identifiers associated with the first plurality of supply orders. In some embodiments, updating the plurality of kit identifiers is performed before assigning the plurality of kit identifiers to the first assembly order and the second assembly order.

[0111] In some embodiments, the one or more electronic devices are further caused to receive, at the first computer system, a rejection of the first assembly order, the second assembly order, or a combination thereof from a user associated with the first computer system, and flag the rejected assembly order for a manual shipping process.

[0112] Although the present disclosure and examples have been fully described with reference to the accompanying figures, it should be noted that various changes and modifications will be apparent to those skilled in the art, and such changes and modifications are understood to be included within the scope of the present disclosure and examples as defined by the claims.

[0113] The foregoing description has been set forth in terms of specific embodiments for purposes of illustration. However, the illustrative description above is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teachings. The embodiments were chosen and described in order to best explain the principles of the technology and its practical application. This will enable those skilled in the art to optimally utilize the technology and various embodiments with various modifications suited to the particular use envisioned. [Explanation of symbols]

[0114] 100 processes 300C process 300D process 300E Process 320A Supply Order 300B Aggregate Order 322B Supply Order 324B Assembly Order 326B Shipping Order 400A User Interface 400B User Interface 400C User Interface 400D User Interface 400E User Interface 400F User Interface 400G User Interface 400H User Interface 400I User Interface 500 devices 510 processor 520 Input Devices 530 output devices 540 Storage 560 Communication Devices

Claims

1. 1. A method for confidentially generating shipping orders for a clinical trial, comprising: A first computer system including one or more processors and one or more memories, receiving a plurality of supply orders associated with one or more clinical trials; determining a clinical trial study, site location, and treatment type for each of the plurality of supply orders; allocating a first plurality of supply orders associated with a first clinical trial study to packaging sites based on the site locations; associating a first subgroup of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order; associating a second subgroup of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order; a second computer system including a second one or more processors and a second one or more memories, receiving the first assembly order and the second assembly order; creating a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order; confidentially generating, at the first computer system, shipping orders for the first plurality of clinical trials based on the plurality of blinded kits; A method comprising:

2. 10. The method of claim 1, wherein the first treatment type corresponds to an active group and the second treatment type corresponds to a control group.

3. In the first computer system, determining a shipment type for the first plurality of supply orders; generating shipment orders for the one or more supply orders associated with the first shipment type according to determining that the one or more supply orders are associated with the first shipment type; generating instructions to store one or more supply orders associated with the second shipment type in accordance with determining that the one or more supply orders are associated with the second shipment type; 3. The method of claim 1 or 2, further comprising:

4. 4. The method of claim 3, wherein the first shipment type corresponds to a pack-to-order request and the second shipment type corresponds to a pack-to-stock request.

5. receiving a request from a first clinical trial site associated with a first supply order of the one or more supply orders associated with the second shipment type; generating a shipping order for the first supply order based on the request from the first clinical trial site; 5. The method of claim 3 or 4, further comprising:

6. The method of claim 1 , wherein the determined site locations of the first plurality of supply orders are associated with the same country.

7. The method of any one of claims 1 to 6, wherein the plurality of supply orders are received via communication with a customer or an application programming interface associated with a client.

8. In the first computer system, receiving input from a client associated with the first clinical trial study corresponding to updated kit identifiers for one or more of the first plurality of supply orders; updating the plurality of kit identifiers associated with the first plurality of supply orders; 8. The method of claim 1, further comprising:

9. 9. The method of claim 8, wherein the step of updating the plurality of kit identifiers is performed before assigning the plurality of kit identifiers to the first assembly order and the second assembly order.

10. In the first computer system, receiving a rejection of the first assembly order, the second assembly order, or a combination thereof from a user associated with the first computer system; Steps to flag rejected assembly orders for manual shipping process and 10. The method of any one of claims 1 to 9, further comprising:

11. one or more processors; Memory and one or more programs stored in the memory and configured to be executed by the one or more processors; A first computer system including one or more processors and one or more memories, receiving a plurality of supply orders associated with one or more clinical trials; determining a clinical trial study, site location, and treatment type for each of the plurality of supply orders; allocating a first plurality of supply orders associated with a first clinical trial study to packaging sites based on the site locations; associating a first subgroup of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order; associating a second subgroup of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order; a second computer system including a second one or more processors and a second one or more memories, receiving the first assembly order and the second assembly order; creating a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order; confidentially generating shipping orders for the first plurality of clinical trials based on the plurality of blinded kits in the first computer system; one or more programs containing instructions for An electronic system comprising:

12. 12. The electronic system of claim 11, wherein the first treatment type corresponds to an active group and the second treatment type corresponds to a control group.

13. The one or more programs, on the first computer system: determining a shipment type for the first plurality of supply orders; generating shipment orders for the one or more supply orders associated with the first shipment type according to determining that the one or more supply orders are associated with the first shipment type; generating instructions for storing one or more supply orders associated with the second shipment type in accordance with determining that the one or more supply orders are associated with the second shipment type; 13. The electronic system of claim 11 or 12, further comprising instructions for:

14. 14. The electronic system of claim 13, wherein the first shipment type corresponds to a pack-to-order request and the second shipment type corresponds to a pack-to-stock request.

15. The one or more programs, on the first computer system: receiving a request from a first clinical trial site associated with a first supply order of the one or more supply orders associated with the second shipment type; generating a shipping order for the first supply order based on the request from the first clinical trial site; 15. The electronic system of claim 13 or 14, further comprising instructions for:

16. 16. The electronic system of claim 11, wherein the determined site locations of the first plurality of assembly orders are associated with the same country.

17. 17. The electronic system of claim 11, wherein the plurality of assembly orders are received via communication with a customer or an application programming interface associated with a client.

18. The one or more programs, on the first computer system: receiving input from a client associated with the first clinical trial study corresponding to updated kit identifiers for one or more of the first plurality of supply orders; updating the plurality of kit identifiers associated with the first plurality of supply orders; 18. The electronic system of claim 11, further comprising instructions for:

19. 20. The electronic system of claim 18, wherein updating the plurality of kit identifiers is performed before assigning the plurality of kit identifiers to the first assembly order and the second assembly order.

20. The one or more programs, on the first computer system: receiving a rejection of the first assembly order, the second assembly order, or a combination thereof from a user associated with the first computer system; Flagging rejected assembly orders for manual shipping process and 20. The electronic system of claim 11, further comprising instructions for:

21. A non-transitory computer-readable storage medium storing one or more programs, the one or more programs, when executed by one or more processors of one or more electronic devices having a display, causing the one or more electronic devices to: A first computer system including one or more processors and one or more memories, receiving a plurality of supply orders associated with one or more clinical trials; determining a clinical trial study, site location, and treatment type for each of the plurality of supply orders; allocating a first plurality of supply orders associated with a first clinical trial study to packaging sites based on the site locations; associating a first subgroup of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order; associating a second subgroup of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order; a second computer system including a second one or more processors and a second one or more memories, receiving the first assembly order and the second assembly order; creating a plurality of blinded kits by randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order; confidentially generating shipping orders for the first plurality of clinical trials based on the plurality of blinded kits in the first computer system; A non-transitory computer-readable storage medium containing instructions to cause

22. 22. The non-transitory computer-readable storage medium of claim 21, wherein the first treatment type corresponds to an active group and the second treatment type corresponds to a control group.

23. The instructions cause the one or more electronic devices to: determining a shipment type for the first plurality of supply orders; generating shipment orders for the one or more supply orders associated with the first shipment type according to determining that the one or more supply orders are associated with the first shipment type; generating instructions for storing one or more supply orders associated with the second shipment type in accordance with determining that the one or more supply orders are associated with the second shipment type; 23. The non-transitory computer-readable storage medium of claim 21 or 22, further comprising:

24. 24. The non-transitory computer-readable storage medium of claim 23, wherein the first shipment type corresponds to a pack-to-order request and the second shipment type corresponds to a pack-to-stock request.

25. The instructions cause the one or more electronic devices to: receiving a request from a first clinical trial site associated with a first supply order of the one or more supply orders associated with the second shipment type; generating a shipping order for the first supply order based on the request from the first clinical trial site; 25. The non-transitory computer-readable storage medium of claim 23 or 24, further comprising:

26. 26. The non-transitory computer-readable storage medium of claim 21, wherein the determined site locations of the first plurality of assembly orders are associated with a same country.

27. 27. The non-transitory computer-readable storage medium of claim 21, wherein the plurality of assembly orders are received via communication with a customer or an application programming interface associated with a client.

28. The instructions cause the one or more electronic devices to: receiving input from a client associated with the first clinical trial study corresponding to updated kit identifiers for one or more of the first plurality of supply orders; updating the plurality of kit identifiers associated with the first plurality of supply orders; 28. The non-transitory computer-readable storage medium of claim 21, further comprising:

29. 30. The non-transitory computer-readable storage medium of claim 28, wherein updating the plurality of kit identifiers is performed before assigning the plurality of kit identifiers to the first assembly order and the second assembly order.

30. The instructions cause the one or more electronic devices to: receiving a rejection of the first assembly order, the second assembly order, or a combination thereof from a user associated with the first computer system; Flagging rejected assembly orders for manual shipping process and 30. The non-transitory computer-readable storage medium of any one of claims 21 to 29, further comprising:

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