System and method for aggregating provisioning orders for pharmaceutical assays

Abstract

Embodiments of the present disclosure include systems and methods for secretly generating shipping orders for clinical trials. The method includes receiving a plurality of provisioning orders associated with one or more clinical trials, and determining clinical trial studies, site locations, and treatment types. The first plurality of provisioning orders is dispatched to the packaging station based on the station location. The method further includes associating a first subset of the first plurality of provisioning orders with a first assembly procedure, associating a second subset of the plurality of provisioning orders with a second assembly procedure, and randomly assigning a plurality of kit identifiers to the first subset and the second subset, thereby creating a plurality of blind method kits. The method further includes secretly generating a shipping order for the first plurality of clinical trials based on the plurality of blind assay kits.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 411,333, filed on September 29, 2022, the entire content of which is incorporated herein by reference. Technical Field

[0003] The present disclosure generally relates to systems and methods for generating shipping orders for clinical trial studies, and more particularly, to systems and methods for generating confidential shipping orders for blinded clinical trial studies. Background Art

[0004] Companies engaged in clinical trial studies, particularly drug clinical trials, are required to comply with government - mandated 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 a regulatory framework for clinical packaging. Accordingly, each clinical packaging operation, whether primary (e.g., placing bulk drugs into bottles, blister packs, vials, or the like) or secondary packaging operations (e.g., labeling primary bottles clinically and placing them in boxes, and then labeling the boxes to create patient kits), must be controllable and repeatable in action and follow appropriate regulatory guidelines. In addition, packaging should be done in a way that does not reveal which kits are associated with which treatment types (e.g., by allowing a participant in the clinical trial or another individual to discover whether a kit is an active treatment or a placebo, thereby unblinding the clinical trial).

[0005] Traditionally, packaging methods for clinical trial studies could be performed to prepare a large number of kits containing drugs for clinical trial studies. The kits could include primary packaging containers (e.g., bottles, blister packs, vials, etc. that hold the drug) and secondary packaging containers (e.g., boxes that contain the primary packaging container and instructions). These kits could be stored in a facility and packaged for shipment upon receiving a request to send a certain quantity of kits to a specific clinical trial site location. More recently, there has been a shift from pre - packaging and storing large numbers of kits to providing just - in - time packaging, where kits are packaged upon or around receiving a request. Just - in - time packaging can reduce waste by packaging only what is required. For example, waste can be reduced when there is a limited drug supply, when a clinical trial study is not progressing in a particular country, or when a clinical trial study does not receive the expected level of patient participation.

[0006] There may be inefficiencies associated with just-in-time packaging. Clinical trial studies often include one or more active drug or treatment types as well as control or placebo treatment types. During the packaging process, each active treatment type and control treatment type are prepared and packaged in separate packaging runs. Each packaging run can be associated with packaging room setup, packaging room cleaning, and separate review and release of the packaged products for each treatment type. For just-in-time packaging where the quantity of kits is relatively small, time and cost can be substantial. Additionally, the packaging should be performed in a manner that does not reveal which kits are associated with which treatment types (e.g., to unblind the study by allowing a participant involved in the study or another individual to discover whether the kit is an active treatment or a placebo). Thus, there is a need to package kits for clinical trial studies confidentially and efficiently. Summary of the Invention

[0007] Embodiments of the present disclosure may provide a computing system and method for efficiently aggregating supply orders. Each supply order can be associated with a destination site, which is associated with a site location that can distribute one or more products or kits to participants in a clinical trial study. In one or more examples, multiple supply orders can be aggregated to create one or more larger assembly orders, where each assembly order is associated with a specific treatment type (e.g., an active treatment type or a control treatment type). Each assembly order can correspond to a packaging run for preparing kits for one or more clinical trial site locations. Embodiments of the present disclosure can further break down the kits produced in a packaging run to generate shipping orders based on the original supply orders.

[0008] In one or more examples, embodiments of the present disclosure can improve the efficiency of the just-in-time packaging process, in which a client can place supply orders in real time for the immediate needs of a site location. As a result, each supply order can correspond to a relatively small packaging run (e.g., including fewer than 100 kits), and not a long-term demand (greater than 100 kits). In some examples, the supply order can include a quantity of fewer than five kits. Since each packaging run can be associated with room setup, room cleaning, and separate review and release of the packaged products, fulfilling packaging supply orders for real-time needs can be time-consuming and expensive. Aggregating supply orders according to embodiments of the present disclosure can result in improved efficiency by reducing the time and cost associated with multiple supply runs for individual supply orders.

[0009] In addition, embodiments of the present disclosure can result in improved confidentiality in generating shipping orders for blinded studies. In many instances, for a clinical trial to be successful, neither the participants nor the individuals conducting the clinical trial should know which drug kits correspond to the active treatment type or the control treatment type. 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 improved methods for 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., a facility that packages the kits). In one or more examples, other parts of the system may not have access to the randomization list.

[0010] Embodiments of the present disclosure provide methods for confidentially generating shipping orders for clinical trials. In one or more examples, the method includes, at 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, for each of the plurality of supply orders: a clinical trial study, a site location, and a treatment type; and dispatching a first plurality of supply orders associated with a 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 to create a first assembly order, and associating a second subgroup of the first plurality of supply orders with a second assembly procedure to create a second assembly order, based on the treatment type. In one or more examples, the method further includes, at 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; and randomly dispatching a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits. In one or more examples, the method further includes confidentially generating shipping orders for a first plurality of clinical trials at the first computer system, based on the plurality of blinded kits.

[0011] In one or more examples, embodiments of the present disclosure include an electronic system that includes one or more processors, a memory, and one or more programs, where the one or more programs are 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 for, at 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, for each of the plurality of supply orders: a clinical trial study, a site location, and a treatment type; and dispatching a first plurality of supply orders associated with a first clinical trial study to a packaging site 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 to create a first assembly order, and associating a second subgroup of the first plurality of supply orders with a second assembly procedure to create a second assembly order, based on the treatment type. In one or more examples, the one or more programs include instructions for, at 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, and randomly dispatching a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits. In one or more examples, the one or more programs include instructions for, at the first computer system: confidentially generating a shipping order for a first plurality of clinical trials based on the plurality of blinded kits.

[0012] 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: at a first computer system including one or more processors and one or more memories, receive a plurality of supply orders associated with one or more clinical trials; for each of the plurality of supply orders, determine: a clinical trial study, a site location, and a treatment type; and based on the site location, dispatch a first plurality of supply orders associated with a first clinical trial study to a packaging site. In one or more examples, further cause the one or more electronic devices 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 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, further cause the one or more electronic devices to: at a second computer system including a second one or more processors and a second one or more memories, receive the first assembly order and the second assembly order, and randomly assign a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits. In one or more examples, further cause the one or more electronic devices to confidentially generate a shipping order at the first computer system based on the plurality of blinded kits for the first plurality of clinical trials. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 FIG. illustrates an exemplary process for confidentially generating a shipping order in accordance with some embodiments of the present disclosure.

[0014] Figure 2 FIG. illustrates an exemplary assembly order in accordance with some embodiments of the present disclosure.

[0015] Figures 3A - 3E FIG. illustrates an exemplary process for confidentially generating a shipping order in accordance with some embodiments of the present disclosure.

[0016] Figures 4A - 4J FIG. illustrates an exemplary user interface for confidentially generating a shipping order in accordance with some embodiments of the present disclosure.

[0017] Figure 5 FIG. illustrates an exemplary electronic device in accordance with embodiments of the present disclosure. DETAILED DESCRIPTION

[0018] 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, which is 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, aggregation of supply orders may be performed to create one or more assembly orders, where each assembly order is associated with a specific treatment type (e.g., an active treatment type or a control treatment type). Each assembly order may correspond to a packaging run for preparing kits for one or more clinical trial site locations. Embodiments of the present disclosure may further break down the kits produced in a packaging run to generate shipping orders based on the supply orders.

[0019] In one or more examples, embodiments of the present disclosure may improve efficiency in a just-in-time packaging process, where a client may issue supply orders in real time for immediate needs at a site location. In a just-in-time packaging process, 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 an amount of fewer than five kits. Since each packaging run may be associated with room setup, room cleaning, and separate review and release of the packaged products, fulfilling packaging supply orders for real-time needs may be time-consuming and expensive. Aggregating supply orders according to embodiments of the present disclosure may improve efficiency by reducing the time and cost associated with multiple supply runs for individual supply orders.

[0020] In addition, embodiments of the present disclosure may result in improved confidentiality in generating shipping orders for blinded studies. In many instances, for a clinical trial to be successful, neither the participants in the clinical trial nor the individuals involved should know which drug kits correspond to an active treatment type or a control treatment type. Frequently, a randomization list is used to map kits (e.g., kit identifiers) to treatment types (e.g., active or control), whether the randomization is performed by the entity running the clinical trial or a vendor or service provider associated with that entity. Embodiments of the present disclosure provide an improved method for 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., a facility that packages kits). In one or more examples, other parts of the system may not have access to the randomization list.

[0021] The following description is presented to enable a person of ordinary skill in the art to make and use various embodiments. The description of specific devices, techniques, and applications is provided only as an example. To a person of ordinary skill in the art, various modifications to the examples described herein will be readily apparent, and the general principles defined herein can be applied to other examples and applications without departing from the spirit and scope of the various embodiments. Thus, the various embodiments are not intended to be limited to the examples described and illustrated herein, but are to be accorded a scope consistent with the claims.

[0022] Although the following description uses the terms “first,” “second,” etc. to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, without departing from the scope of the various described embodiments, 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. Both the first graphical representation and the second graphical representation are graphical representations, but they are not the same graphical representation.

[0023] The terms used in the description of the various described embodiments herein are for the purpose of describing particular embodiments only and are not intended to be limiting. As used in the description of the various described embodiments and the appended claims, the singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context clearly indicates otherwise. It will also be understood that the term “and / or” as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It will be further understood that the terms “include,” “including,” “comprise,” and / or “comprising” when used in this specification specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof.

[0024] Depending on the context, the term “if” may optionally be interpreted to mean “when” or “upon” or “in response to determining” or “in response to detecting.” Similarly, depending on the context, the phrase “if it is determined that” or “if [the stated condition or event] is detected” may optionally be interpreted to mean “upon determining” or “in response to determining” or “when [the stated condition or event] is detected” or “in response to detecting [the stated condition or event].”

[0025] Figure 1Illustrated is an exemplary process 100 for confidentially generating shipping orders for one or more clinical trial studies, the shipping orders including one or more blinded kits. For example, one or more electronic devices implementing a software platform may be used to execute process 100. In some examples, a client-server system is used to execute process 100, and the blocks of process 100 are divided between the server and client devices in any manner. In other examples, the blocks of process 100 are divided between the server and multiple client devices. In other examples, process 100 is executed using only one client device or only multiple client devices. In process 100, some blocks are optionally combined, the order of some blocks is optionally changed, and some blocks are optionally omitted. In some examples, additional steps may be combined with the execution of process 100. Accordingly, the operations illustrated (and those described in more detail below) are exemplary in nature and, as such, should not be considered restrictive.

[0026] At Figure 1 block 102 of, the system may receive, at a first computer system, multiple supply orders associated with one or more clinical trials. The multiple supply orders may relate to a specific clinical trial study associated with a client.

[0027] In one or more examples, the system may receive the multiple supply orders from a client via direct communication such as, for example, email, telephone, letter, etc. In one or more examples, the system may receive the 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 when it receives the multiple supply orders via the API.

[0028] At Figure 1 block 104 of, the system may determine, at the first computer system, for the multiple supply orders: the clinical trial study, and the site location. In one or more examples, the system may determine additional information associated with the multiple supply orders.

[0029] Figure 2 Illustrated is exemplary data that may be associated with a supply order. As shown in the figure, a supply order may include client data, clinical trial study data, site location data, packaging type, quantity per packaging type, blinding type, and shipping type. Figure 2 The types of information shown in are exemplary, and more or fewer information may be associated with the supply order without departing from the scope of the present disclosure.

[0030] In one or more examples, client data may indicate the identity of a client requesting a supply order. In one or more examples, a clinical trial study may associate a supply order with a specific clinical trial study. In one or more examples, a clinical trial study may be identified by a number corresponding to the specific clinical trial study. In one or more examples, a site location may correspond to a specific location associated with a clinical trial study that is to receive a product requested via a supply order. In one or more examples, a packaging type may indicate the type of material (e.g., drug, pharmaceutical dosage, bottle, syringe, label, etc.). For example, a first packaging type associated with a clinical study may correspond to a first dose of a specific drug to be provided in a bottle with a first type of label, a second packaging type associated with the same clinical study may correspond to a placebo to be provided in a bottle with a first type of label, and a third packaging type associated with the clinical study may correspond to a second dose of a specific drug to be provided in a bottle with a first type of label. Those skilled in the art will understand that the number of packaging types, drugs, and prescription doses will vary based on the parameters of the clinical trial study. In one or more embodiments, the quantity of kits for each packaging type may indicate how many kits have been ordered for each packaging type. In one or more examples, a blinding type may indicate whether the study is blinded. In one or more examples, a shipping type may refer to ship-to-order or ship-to-stock shipping.

[0031] As an example, a client may be planning a clinical trial to test a specific drug and evaluate the efficacy 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 quantity of kits. For example, a clinical trial study may be associated with locations in Philadelphia, Pennsylvania and Urbana, Illinois. The Philadelphia location may be expected to include a higher number of participants, and thus, the quantity of kits at these locations may be different.

[0032] Figure 3AIllustrated is an exemplary process 300A associated with blocks 102 and 104. At block 302, the system can receive a supply order 320A by, for example, calling 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, the supply order 320A can include three supply orders that can be associated with three drug types across the order. For example, the first supply order can be associated with three products of the first packaging type (SO1 = PT1 × 3) and three products of the second packaging type (SO1 = PT2 × 3); the second supply order can be associated with five products of the first packaging type (SO2 = PT1 × 5); and the third supply order can be associated with two products of the first packaging type (SO3 = PT1 × 2) and two products of the second packaging type (SO3 = PT3 × 2). As used herein, a product can refer to a packaged kit intended to be distributed to clinical trial study participants. The product or kit can include a predetermined amount of a specific drug packaged in a predetermined container (e.g., a bottle, a blister pack, a syringe, etc.) with a predetermined label. In one or more examples, the first packaging type can correspond to the first drug type at the first dose, the second packaging type can correspond to a placebo, and the third packaging type can correspond to the first drug type at the second dose. For example, the first packaging type can correspond to aspirin at a 100 mg dose, the second packaging type can correspond to a placebo, and the third packaging type can correspond to aspirin at a 50 mg dose. Those skilled in the art will understand that these drugs and doses are exemplary and any drugs and doses can be used without departing from the scope of the present disclosure.

[0033] At block 304A, the system can check for errors associated with the received supply order 320A. If an error is detected, the system can communicate with an external system to resolve the error. If no error is detected, then at block 306A, the system can determine whether the received supply order 320A is quantity-driven or kit-driven. Each of the kits can be associated with a unique sequence identification number. In one or more examples, a quantity-driven order can refer to a supply order where the client specifies a particular number of kits and is agnostic to the unique sequence identification number associated with the kit. In one or more examples, a kit-driven supply order can refer to a supply order where the client specifies a particular sequence identification number. If the system determines that the supply order is kit-driven, the system can proceed to block 308A, where the system can verify the kit number against known inventory numbers. At block 310A, the system can determine whether the kit number is invalid. If the number is invalid, the system can flag an error. If the kit number can be verified against known inventory numbers, the system can create an aggregated supply order at block 312A. If the system determines that the supply order is quantity-driven, the system can proceed to create an aggregated supply order at block 312A.

[0034] Return to Figure 1 , at block 106, the system can dispatch a first plurality of supply orders associated with a first clinical trial study to a packaging site at a first computer system based on site locations. In one or more examples, the first plurality of supply orders can correspond to supply orders associated with multiple site locations within the same country. For example, different countries can have different rules and regulations regarding the provision and packaging of drugs used in clinical trials. Thus, the first plurality of supply orders for site locations within the same country will be subject to the same packaging requirements. For example, if the system receives a first plurality of supply orders with clinical trial study site locations in the United States, Canada, and Japan. In such an example, the first plurality of supply orders can be associated with a clinical trial study located in the United States; a second plurality of supply orders can be associated with a clinical trial study located in Canada; and a third plurality of supply orders can be associated with a clinical trial study located in Japan. In one or more examples, as permitted by the design of the clinical trial study, the plurality of supply orders can be associated with one or more countries.

[0035] In one or more examples, the system can automatically assign packaging sites to a first plurality of supply orders based on clinical trial site locations. In one or more examples, the packaging sites can be predetermined based on the country in which the site location is located. In one or more examples, the packaging sites can be based on whether the site locations are in the same country. In one or more examples, the packaging sites can be based on whether the site locations are in the same region. In one or more examples, the packaging location can be preconfigured such that when a request from a specific site location is received, the packaging site can be automatically assigned.

[0036] In one or more examples, supply orders that have been assigned to a packaging site can be placed in an aggregator queue (e.g., Figure 4E as shown in). In one or more examples, each packaging site can be associated with a separate queue. In one or more examples, an operator can manually enter into the system which supply orders should be aggregated from the queue. In one or more examples, the system can automatically determine which supply orders should be aggregated from the queue. In one or more examples, a user associated with the system can determine which supply orders should be aggregated from the queue. For example, the system can display a preview of the aggregation of the expected assembly orders and shipping orders (e.g., Figure 4F as shown in).

[0037] In one or more examples, blocks 108 and 110 are associated with the process of aggregating supply orders in accordance with embodiments of the present disclosure. As discussed above, traditionally, each supply order is prepared separately. Supply orders that include multiple packaging types can be prepared in multiple packaging rounds. For example, each packaging type can be associated with specific packaging, materials, protocols, and requirements, such that products of different packaging types can be produced in separate packaging rounds. When there are multiple supply orders that include multiple packaging types, using these methods to package the supply orders can be inefficient, costly, and time-consuming. For example, each packaging round can be associated with room setup, room cleaning, and separate reviews and releases of the packaged products. Thus, a single supply order can be associated with multiple room setups, room cleanings, and reviews and releases of the packaged products.

[0038] In Figure 1At block 108, the system may associate a first subgroup of the first plurality of supply orders with a first assembly program at the 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, referring 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. Referring to supply order 320A, the first subgroup may correspond to three products of packaging type 1 from the first supply order (SO1 = PT×3), five products of packaging type 1 from the second supply order (SO2 = PT×5), and two products of packaging type 1 from the third supply order (SO3 = PT×2).

[0039] At Figure 1 block 110, the system may associate a second subgroup of the first plurality of supply orders with a second assembly program at the first computer system. For example, referring 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 from the first supply order.

[0040] To the extent that process 100 includes creating first and second assembly orders, those skilled in the art will understand that the number of assembly orders created is not intended to limit the scope of the present disclosure. More or fewer assembly orders may be created based on the parameters of a particular clinical trial study. For example, referring to supply order 320A, the method may further include associating a third subgroup of the first plurality of supply orders with a third assembly program.

[0041] For example, referring to supply order 320A, packaging three supply orders according to this method will result in five separate packaging rounds. Two packaging rounds associated with the first supply order, for example, a first packaging round of the first packaging type (SO1 = PT1×3) and a second packaging round of the second packaging type (SO1 = PT2×3); one packaging round of the second supply order associated with the first packaging type (SO2 = PT1×5); and two additional packaging rounds for the third supply order, for example, a first packaging round of the two orders of the first packaging type (SO3 = PT1×2) and a second packaging round of the two orders of the second packaging type (SO3 = PT3×2). Each packaging round may be associated with a separate room setup, separate room cleaning, separate review of the packaged product, and separate release of the packaged product. The time associated with performing these separate tasks may increase costs, time, and inefficiencies.

[0042] Figure 3BIllustrated is an exemplary aggregated order 300B according to an embodiment of the present disclosure. As shown in the figure, the 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, Figure 3B may be associated with steps 108 and 110. As shown in the figure, embodiments of the present disclosure may reduce the number of packaging rounds by aggregating orders associated with the same packaging type. For example, orders with the same packaging type may be associated with kits including the same type of drug, the same amount of drug, and drugs with similar packaging. Thus, these orders with the same packaging type may be associated with the same protocol (e.g., at least because 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 rounds and associated overheads (e.g., separate batch record creation, room setup, room cleaning, review, and release).

[0043] The aggregated order 300B may correspond to an exemplary order aggregation of the supply order 320A. For example, the supply order 322B may correspond to the supply order 320A, where the supply order may be associated with different site locations and one or more packaging types. The site locations may be within the same country. For example, the first supply order may be associated with three products of the first packaging type (SO1 = PT1 × 3) and three products of the second packaging type (SO1 = PT2 × 3); the second supply order may be associated with five products of the first packaging type (SO2 = PT1 × 5); and the third supply order may be associated with two products of the first packaging type (SO3 = PT1 × 2) and two orders of the second packaging type (SO3 = PT3 × 2).

[0044] Figure 3B The assembly order 324B of illustrates the aggregation of supply orders based on the packaging type. For example, as shown in the figure, 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. Thus, embodiments of the present disclosure may reduce the number of packaging rounds associated with these three supply orders from five separate rounds associated with traditional packaging methods to three rounds. Those skilled in the art will understand that these efficiency gains are even more significant as the number of supply orders increases.

[0045] Although the number of supply orders 322B is the same as the number of assembly orders 324B, those skilled in the art will understand that the number of supply orders may be different from the number of assembly orders based on the packaging types included in the supply orders selected for aggregation.

[0046] Figure 3BShipping order 326B illustrates how the system can break down an assembly order into shipping orders based on a supply order. For example, a packaged product can be allocated based on the original supply order 320A. As shown in the figure, shipping order 1 can correspond to supply order 1, such that the quantities of products of various packaging types are the same. For example, shipping order 1 and supply order 1 include three products of the first packaging type and three products of the second packaging type. As shown in the figure, shipping order 2 can correspond to supply order 2, and shipping order 3 can correspond to supply order 3.

[0047] Figure 3C Illustrates an exemplary process 300C associated with blocks 108 and 110. At block 302C, the system can create an assembly order based on the packaging type. At block 304C, the system can create shipping orders based on the supply order, where there will be one shipping order associated with each site location for which a supply order has been submitted. Blocks 302C and 304C can be associated with the aggregation order 300B described above.

[0048] In one or more examples, the system can display an aggregation preview based on blocks 302C and 304C. In one or more examples, the system can confirm or receive confirmation of the aggregation preview. Once confirmed, the system can aggregate the supply orders to generate an assembly order and shipping orders. The system can generate three ID types as part of each new aggregated order: a single aggregated 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.

[0049] Once the assembly order and shipping orders are created, the system can change the aggregation order status to new at block 306C. This status change can indicate to the system that the assembly order is ready for review before being sent to the packaging site. For example, the system can confirm the availability of packaging materials (e.g., drugs, bottles, blister packs, labels, etc.) at the packaging site. At block 308C, the system can enter the labeled batch number and expiration date. In one or more examples, the labeled batch number can be received from an external system via an API.

[0050] At block 310C, the system can confirm or change the labeled batch number and expiration date of the aggregation order. In one or more examples, after the batch number and expiration date are assigned, the system can then mark the aggregation order as scheduled.

[0051] At block 312C, the system can determine whether the marked batch number and expiration date are approved. If the marked batch number and expiration date are not approved, the system can wait for approval at block 314C or change the assembly order by removing one or more supply orders associated with the assembly order. If the marked batch number and expiration date are approved, the system can display at block 316C the amount of materials with the approved marked batch number from the external integration system. At block 318C, the system can check to determine whether the materials for packaging the assembly order are available. In one or more examples, the system can confirm the availability of packaging materials (such as drugs, bottles, blister packs, labels, etc.) at the packaging site. Then, at block 320C, the system can mark the aggregated order as scheduled.

[0052] Figure 3D Illustrated is an exemplary process 300D executed by a first computer system and associated with creating an aggregated order (such as an aggregation system). Process 300D is a continuation of process 300C. Once the aggregated order status is sent to scheduling, the system can initially assign a batch identifier and an expiration date at block 304 and save the order at block 306D. In one or more examples, the system can send a notification to a second computer system associated with the packaging site that a newly created aggregated 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 aggregated order and verify the availability of packaging materials at the packaging site, schedule packaging rounds, and assign each assembly order to packaging against the initially assigned batch identifier and expiration date. In one or more examples, the batch identifier can be updated based on client preferences. For example, the client can specify a preferred batch identifier. Once all assembly orders are assigned, the aggregated order is marked as submitted at step 308D.

[0053] In one or more examples, the submitted aggregated order can initiate an external process to create a work order and an executable batch record, which are then used by a quality assurance operator user to review each assembly order and mark it as approved for packaging at block 314D. In one or more examples, the quality assurance operator can ensure that the batch identifier corresponds to the batch identifier specified by the client.

[0054] Once the assembly order is approved at block 310D, the aggregated order is marked as approved for packaging.

[0055] In one or more examples, a quality assurance operator may approve or reject each assembly order and perform batch release at block 312D. As part of the batch release, the system may confirm the drug identifier, the order of use printed for each serialized assembly order, and the shipping order from an external system. After all assembly orders have been packed / rejected, the system may receive an indication as to whether the aggregate order is packed or rejected. In one or more examples, a rejected aggregate order may be processed via a manual process separate from the system.

[0056] At Figure 1 block 112, the system may receive a first assembly order and a 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 way, a first plurality of supply orders associated with the same clinical trial and site location in the same country may be packaged at the same packaging facility.

[0057] At Figure 1 block 114, the system may randomly assign a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits. In one or more embodiments, randomly assigning a plurality of kit identifiers may include assigning a selected range of pre-randomized kit identifiers. In such an embodiment, the numbers corresponding to the pre-randomized kit identifiers may be selected without knowing the drug type represented by the kit identifier. The assembly orders may be packaged based on this randomization. In one or more examples, while the second computer system associated with the packaging site can access the randomization list to determine which kits are associated with the active drug or placebo, the first computer system may not be able to access the randomization list. In this way, the system may confidentially package the original supply orders and attenuate the randomization information (e.g., associated with the aggregation of the supply orders) from the first computer system, thereby reducing the likelihood that the study may become unblinded.

[0058] In one or more examples, the kit identifier may be specified by a customer, such as an individual associated with a clinical trial study. For example, the system at the first computer system may receive an input from a customer associated with a first clinical trial study, where the input includes 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. At block 114, the update of the kit identifiers may be completed before the plurality of kit identifiers are assigned to the first assembly order and the second assembly order.

[0059] Figure 3EIllustrated is an exemplary process 300E associated with block 114. Blocks associated with process 300E may occur at a second computer system associated with a packaging site. At block 302E, the second computer system may randomize kit identifiers based on the packaging type, e.g., by associating the kit identifier 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 identifier may be obtained from a first computer system. In one or more examples, a randomized list associating the kit identifier with the active or placebo packaging type 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.

[0060] At block 304E, the system may fulfill a scan assembly order. In one or more examples, the scan assembly order may be performed by an external scan assembly system. The scan assembly system may be configured to verify the selected kit ID and provide control and traceability of kit movement. 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 in the first computer system is transferred to the scan assembly system to create the master packout. In one or more examples, at block 308E, the system may associate a packaging job (e.g., corresponding to the assembly order) with the master packout job. For example, the scan assembly system may receive a reference label and individual kit IDs from the first computer system, and the scan assembly system may manage the packing of the shipment to ensure that the kit IDs match the correct shipment. In one or more examples, at step 310E, the system may create a sub-packaging job. The sub-packaging job may refer to the packaging of each drug type, e.g., as described above, one drug may be present in the packaging room at a time. For the sub-packaging job, the system may determine at step 312E whether the supply order is quantity-driven or kit-driven. If the supply order is quantity-driven, then at block 314E, the system may determine the quantity of the material type from the assembly job. If the supply order is kit-driven, the system may obtain the aggregated order details, including the material identifier from the first computer system. At block 318E, the system may fulfill the packaging job.

[0061] At Figure 1At block 116, the system can confidentially generate shipping orders at the first computer system based on multiple blinded kits for the first plurality of clinical trials. For example, the system decomposes the assembly order into shipping orders 326B based on the received supply order 322B, as described above for the aggregated order 300B. For example, each shipping order can be associated with a single site location and include kits to be packaged based on one or more assembly orders. As previously discussed, since the randomization information is maintained at the second computer system, the shipping orders can be generated confidentially, e.g., such that the study cannot be unblinded. In this way, in addition to the improved packaging efficiency provided by aggregating supply orders, embodiments of the present disclosure also provide improved security when preparing supply orders for clinical trial studies.

[0062] In one or more examples, the system can receive an indication that the packing operation has been fulfilled and the assembly order has been packaged. In one or more examples, the second system can transmit to the first system that the assembly order has been packaged. In one or more examples, the system can first perform a quality assurance check on the packaged assembly order. If the assembly order fails the quality assurance check, the assembly order can be flagged for manual review and / or the shipping process. After the quality assurance check, batch release can be performed. Batch release can confirm the material identifier, the order of use printed for each assembly order, and the order of use of the shipping order from an external system or application.

[0063] Embodiments of the present disclosure further provide the flexibility to implement both pack-to-order and stock-to-pack shipping types. As used herein, pack-to-order can refer to a supply order received by the system and subsequently to be shipped to a designated site location associated with a clinical trial. As used herein, stock-to-pack can refer to a supply order received by the system and subsequently to be stored at a facility (e.g., a packaging facility or a designated warehouse) for shipment to a site location at a later date. In one or more examples, the site location associated with the stock-to-pack shipping type may not be known when the supply order is issued.

[0064] In one or more examples, the system can determine the shipping type of a first supply order among the first plurality of supply orders at the first computer system. If the supply order is associated with the pack-to-order shipping type, the first system can generate a shipping order as described above. For example, a first shipping order can be generated confidentially based on multiple blinded kits. Then, the packaged kits associated with the first shipping order can be shipped to the appropriate clinical trial site location.

[0065] If a supply order is associated with a stock-based packaging and shipping type, the first computer system may generate instructions for storing kits produced based on the supply order. The kits may be stored at a packaging facility or a warehouse facility. Later, the first computer system may receive a request from a first clinical trial site for materials associated with the supply order. In such an example, the system may generate a shipping order for the supply order based on the request from the clinical trial site location. In this way, the customer may maintain a quantity of packaging materials as a reserve. This may provide the customer with more flexibility to reach additional participants in a clinical trial study by accessing the pre-packaged materials without having to go through a new packaging round.

[0066] 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 produced via the assembly orders may be broken down 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 late production phase, and a shipping phase. These phases may be associated with one or more blocks described above with respect to process 100.

[0067] In one or more examples, as part of the planning phase, the system may receive multiple supply orders from an external system or application, e.g., when the external system discovers site requirements 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 location may be based on whether the site location is in the same country. In one or more examples, the packaging location may be based on whether the site location is in the same region. In one or more examples, the packaging location may be pre-configured such that when a request is received from a specific site location, the packaging location may be automatically assigned.

[0068] In one or more examples, supply orders that have been assigned to a packaging site may be placed in an aggregator queue (e.g., as shown in Figure 4E ). In one or more examples, each packaging site may be associated with a separate 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 aggregation of the expected assembly order and shipping order (e.g., as shown in Figure 4F ).

[0069] The system can confirm or receive confirmation of the aggregated preview. Once confirmed, the system can aggregate supply orders to generate assembly orders and shipping orders. The system can generate three ID types as part of each new aggregated order: a single aggregated 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.

[0070] In one or more examples, the system can confirm the availability of packaging materials (e.g., drugs, bottles, blister packs, labels, etc.) at the packaging site. The system can further initially assign a batch identifier and a due date. Then, the system can mark the aggregated 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 aggregated 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 aggregated order, verify the availability of packaging materials at the packaging site, schedule packaging rounds, and assign each assembly order to packaging against the initially assigned batch ID and due date. In one or more examples, the batch identifier can be updated based on client preferences, e.g., the client can specify a preferred batch identifier. Once all assembly orders have been assigned, the aggregated order is marked as submitted.

[0071] In one or more examples, the submitted aggregated order can initiate an external process to create work orders and executable batch records, which can then be used by quality assurance operator users 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 batch identifier corresponds to the batch identifier specified by the client. Once the assembly order is approved, the aggregated order is marked as approved for packaging. In one or more examples, the aggregated order can include only auxiliary equipment. In such an example, the aggregated order will go directly into late production without a planning activity.

[0072] In one or more examples, as part of the late production stage, the quality assurance operator can approve or reject each assembly order and perform batch release. As part of the batch release, the system can confirm the drug identifier, the usage sequence printed for each serialized assembly order, and the shipping order from an external system. After all assembly orders have been packaged / rejected, the system can receive an indication of whether the aggregated order has been packaged or rejected. In one or more examples, the rejected aggregated order can be processed via a manual process separate from the system.

[0073] In one or more examples, the system can receive an indication as to whether the secondary batch is part of an aggregated order. In one or more examples, the secondary batch can refer to non-manufactured purchased items included within an order (e.g., syringes, alcohol-based wipes). These secondary items can be considered generic and non-unique.

[0074] In one or more examples, once the assembly order is packaged and the secondary information has been entered, the shipping order can be ready for pre-distribution. In one or more examples, as part of the shipping phase, the system can mark the aggregated order as approved for shipment, which can generate a shipping plan for each of the shipping orders within the aggregation that have a pick-to-order (PTO) shipping type. No shipping plan will be created for pick-to-stock (PTS) shipping types. PTS orders will be packaged and held at the packaging facility or warehouse.

[0075] 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 the shipping process and update the status of the shipping order associated with the aggregated order to a sent status. If an error occurs during the shipping process, the system can flag a manual review of the shipment before notifying the external system. The system can receive verification that the shipment of the product has been shipped or delivered from one or more external systems and update the status of the aggregated order accordingly.

[0076] Figures 4A - 4J An exemplary user interface in accordance with an embodiment of the present disclosure is illustrated.

[0077] Figure 4A An exemplary user interface 400A corresponding to a login screen of a first computer system is illustrated. In one or more examples, a user associated with the first computer system can be prompted to log in to the first computer system via the user interface 400A. As shown in the figure, the user interface 400A can include one or more user prompts for receiving a username and password from the user. The user interface can further include a user prompt (e.g., a login button) for the user to log in to the first computer system when the username and password are provided.

[0078] Figure 4BIllustrated is an exemplary user interface 400B corresponding to the login 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 a plurality of user cues for navigating to different segments of the first computer system. For example, the user interface 400B includes an aggregator user cue, an administrator user cue, and a scan assembly user cue. The user interface 400B may further include a summary of login attempts previously made by the user. This may be provided as a security measure for the user to ensure that there has been no unauthorized access to their account recently.

[0079] Figure 4C Illustrated is an exemplary user interface 400C corresponding to the administration page of a first computer system. As shown in the figure, the administration page may include a navigation bar that allows a user to navigate to one or more user interfaces associated with users, external systems and programs, projects, and audit trails.

[0080] Figure 4D Illustrated is an exemplary user interface 400D corresponding to an exemplary aggregator page of a first computer system. As shown in the figure, the aggregator page 400D may be associated with a queue segment. The queue segment may be adapted to display one or more queued supply orders. For example, queued supply orders may be displayed based on selected criteria including a client, a project (e.g., a clinical trial study), a destination country, an order type (e.g., initial, normal, emergency), and / or a text search. As used herein, an initial order may refer to the first order for a site. As used herein, a normal order may refer to a standard order for a site that may be executed with a standard lead time. As used herein, an emergency order may correspond to an order that needs to be expedited and completed faster 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 cue. Queued supply orders based on the selected information may be displayed on the aggregator page 400D.

[0081] In one or more examples, the user interface may be adapted to display information related to: a supply order identifier, a material type (e.g., a drug and dosage, packaging material, labeling material, etc.), when the supply order was received, a destination site (e.g., where the supply order should be shipped), and a requested delivery date of the queued supply order. In one or more examples, the information displayed in the queued order list may be based on the selected criteria. For example, if a destination country is selected, the information displayed may omit the destination country in the queued order list (e.g., the column corresponding to the destination country may be omitted). This may reduce clutter and enhance the readability of the user interface by eliminating redundant information from the presented content.

[0082] Figure 4E Illustrated is an exemplary user interface 400E corresponding to an exemplary aggregator page of a first computer system. As shown in the figure, the aggregator page 400E can be associated with a queue segment where the system has received information related to a selected client, project (e.g., clinical trial study), destination country, and order type (e.g., initial, normal, emergency). As shown in the figure, the system can display a plurality of queued orders based on the received information. As shown in the figure, a plurality of supply orders may be associated with the same destination site and / or material type.

[0083] For example, the supply order ID 01-0079 issued on June 4, 2022 can be associated with material type 3 and corresponds to a requested quantity 32 to be shipped to destination site 16; the supply order ID 01-0074 issued on June 4, 2022 can be associated with material type 3 and corresponds to a requested quantity 13 to be shipped to destination site 6; the supply order ID 01-0073 issued on June 4, 2022 can be associated with material type 3 and corresponds to a requested quantity 19 to be shipped to destination site 5; the supply order ID 01-0072 issued on June 4, 2022 can be associated with material type 3 and corresponds to a requested quantity 9 to be shipped to destination site 4; the supply order ID 01-0072 issued on May 26, 2022 can be associated with material type 3 and corresponds to a requested quantity 25 to be shipped to destination site 6; the supply order ID 01-0066 issued on May 25, 2022 can be associated with the same material type 3 and corresponds to a requested quantity 13 to be shipped to destination site 5; the supply order ID 01-0068 issued on May 25, 2022 can be associated with the same material type 3 and corresponds to a requested quantity 9 to be shipped to destination site 4; and the supply order ID 01-0066 submitted on May 24, 2022, can be associated with the same material type 3 and corresponds to a requested quantity 13 to be shipped to destination site 4. According to an embodiment of the present disclosure, since these supply orders enumerated above correspond to the same material type (e.g., packaging type), the same client, the same clinical trial study, and the same destination country, the system can aggregate these orders together for packaging. In contrast, previous systems may have generated separate packaging rounds for each of the orders.

[0084] Although each of the client, project, destination country, and order type fields is selected in the user interface 400E, in one or more examples, more or fewer fields can be utilized to display a list of queued supply orders. For example, the system can display queued supply orders based on the client and the project.

[0085] Figure 4F An exemplary user interface 400F corresponding to an exemplary aggregator page of a first computer system is illustrated. As shown in the figure, the aggregator page 400F can be associated with an aggregation preview. The aggregation preview can include an assembly order segment that displays a list corresponding to different assembly orders and a shipping order segment that displays a list 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 the user interface 400E. For example, the user interface 400F can be based on the selection of supply order IDs 01-0081 and 01-0079 shown in the user interface 400E. As shown in the figure, the user interface can provide user cues to confirm or cancel the displayed aggregation preview. Confirming the aggregation preview can remove the corresponding supply order from the queue.

[0086] Referring to the user interface 400F, the assembly order segment can include information about the study type (e.g., blinded or open), material type (e.g., package type), material description (e.g., drug and dosage), and kit identifier. As shown in the figure, although the assembly order associated with material type 3 is indicated as a blinded study, the unblinding information may not be displayed to the user or may not be accessible to the user via the user interface 400F.

[0087] The shipping order segment can include information about the destination site, replenishment type (e.g., pick and pack or ship and pack), shipping group, finished product quantity, and kit identifier. In one or more examples, the shipping order information can be based on the supply order information.

[0088] Figure 4GIllustrated is an exemplary user interface 400G corresponding to an exemplary aggregator page of a first computer system. The user interface 400G can be associated with a supply order page. As shown in the figure, the user interface 400G can display a list of supply orders. The list of supply orders can be displayed based on a selected client, project (e.g., clinical trial study), destination country, order type (e.g., initial, normal, emergency), order status (e.g., queued, new, planned), and / or text input received from the user. The supply order list can be displayed based on one or more of these parameters. For each supply order included in the list, the user interface 400G can display but is not limited to the supply order identifier, order status, aggregated order identifier, date the supply order was received, client name, project (e.g., clinical trial study), source (e.g., whether the order was received via an application or direct client communication), requested delivery date, destination site, and destination country. As shown in the user interface 400G, the supply order list corresponds to a selection of order type and order status. In one or more examples, the information displayed in the queued order list can be based on the selected criteria. For example, if no destination country is selected, the information displayed can include the destination country in the queued order list (e.g., the column corresponding to the destination country can be omitted), as shown in the user interface 400G. This can reduce clutter and enhance the readability of the user interface.

[0089] Figure 4HIllustrated is an exemplary user interface 400H corresponding to an exemplary aggregator page of a first computer system. The user interface 400H may correspond to a supply order details page associated with the 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 the user interface 400H, the supply order details page may display information associated with but not limited to the supply order, the supply order including general information, the general information including order status, date the supply order was received, client name, item (e.g., clinical trial study), source (e.g., whether the order was received via an application or direct client communication), 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. The user interface 400H may also display shipping details, including shipping address and shipping instructions. The user interface 400H may also display finished product information, including but not limited to study type (e.g., blinded or open), replenishment type (e.g., pack-on-order and pack-on-stock), material type, material description, quantity, assembly order ID, and shipping order ID. The user interface 400H may also include information about any ancillary items associated with the supply order. Those skilled in the art will understand that these user interfaces are exemplary and may include more or less information without departing from the scope of the present disclosure.

[0090] Figure 4I Illustrated is an exemplary user interface 400I corresponding to an exemplary aggregated order page of a first computer system. The user interface 400I may display a list of aggregated orders based on one or more selected criteria. As shown, the one or more selected criteria may include client, item, destination country, order status, or text search. The aggregated orders may correspond to one or more of the aggregated orders described above with respect to blocks 108 and 110 and Figure 3B and 3C described. The information displayed for each of the aggregated orders may include but not limited to aggregated order identifier, order status, aggregation date, client, item (e.g., clinical trial study), destination country, one or more supply orders including the aggregated order, and requested delivery date. In one or more examples, the information displayed in the list of queued orders may be based on the selected criteria. For example, if the destination country is not selected, the information displayed may include the destination country in the list of queued orders (e.g., the column corresponding to the destination country may be omitted), as shown in the user interface 400I.

[0091] Figure 4JIllustrated is an exemplary user interface 400I corresponding to an exemplary aggregated order page of a first computer system. The user interface 400I corresponds to a details page associated with a particular aggregated order (e.g., aggregated order AG-218). As shown in the figure, the aggregated order details page may include general information related to the aggregated order, including but not limited to the client, order status (e.g., packaged, scheduled, queued, new, shipped), aggregation date, item (e.g., clinical trial study), requested delivery date, client protocol number, destination country, packaging hub (including city and country). The user interface 400I 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 400I may display information including but not limited to the shipping order identifier, destination site, replenishment type, shipping group, finished product quantity, kit identifier, auxiliary quantity, supply order number, and order status. The user interface 400I may further include one or more comments. In addition to the comments themselves, the one or more comments may identify the user who made the comment and the date corresponding to when the comment was posted.

[0092] Those skilled in the art will understand 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.

[0093] The operations described with reference to the above figures are optionally implemented by Figure 5 the components depicted in. Those of ordinary skill in the art will be clear on how to implement other processes based on Figure 5 the components depicted in.

[0094] Figure 5 Illustrated is 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 Figure 5 shown in, device 500 may be any suitable type of microprocessor-based device, such as a personal computer, workstation, server, or a handheld computing device (portable electronic device), such as a phone or a tablet. The device may include, for example, one or more of a processor 510, an input device 520, an output device 530, a storage device 540, and a communication device 560. The input device 520 and the output device 530 may generally correspond to those described above and may be connectable or integrated with the computer.

[0095] The input device 520 can be any suitable device that provides input, such as a touch screen, keyboard or keypad, mouse, or voice recognition device. The output device 530 can be any suitable device that provides output, such as a touch screen, haptic device, or speaker.

[0096] The storage device 540 can be any suitable device that provides storage, such as electrical, magnetic, or optical memory, including RAM, cache, hard disk drive, or removable storage disk. The communication device 560 can include any suitable device capable of transmitting and receiving signals over a network, such as a network interface chip or device. The components of the computer can be connected in any suitable manner, such as via a physical bus or wirelessly.

[0097] The software 550 that can be stored in the storage device 540 and executed by the processor 510 can include, for example, programming that embodies the functionality of the present disclosure (e.g., as embodied in the devices described above).

[0098] The software 550 can also be stored and / or conveyed within any non-transitory computer-readable storage medium for use by or in connection with an instruction execution system, apparatus, or device (such as those described above), which can obtain the instructions associated with the software from the instruction execution system, apparatus, or device and execute the instructions. In the context of the present disclosure, a computer-readable storage medium can be any medium, such as the storage device 540, that can contain or store programming for use by or in connection with an instruction execution system, apparatus, or device.

[0099] The software 550 can also be propagated within any conveyance medium for use by or in connection with an instruction execution system, apparatus, or device (such as those described above), which can obtain the instructions associated with the software from the instruction execution system, apparatus, or device and execute the instructions. In the context of the present disclosure, a conveyance medium can be any medium capable of transmitting, propagating, or conveying programming for use by or in connection with an instruction execution system, apparatus, or device. The conveyance-readable medium can include, but is not limited to, electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.

[0100] The device 500 can be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communication protocol and can be protected by any suitable security protocol. The network can include any suitable arrangement of network links capable of implementing the transmission and reception of network signals, such as a wireless network connection, T1 or T3 line, cable network, DSL, or telephone line.

[0101] Device 500 may implement any operating system suitable for operation on a network. Software 550 may be written in any suitable programming language, such as C, C++, Java, or Python. In various embodiments, the application software embodying the functionality of the present disclosure may be deployed in different configurations, such as, for example, in a client / server arrangement or as a web-based application or web service via a web browser.

[0102] Embodiments of the present disclosure provide methods for confidentially generating shipping orders for clinical trials. In one or more examples, the method includes, at 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; for each of the plurality of supply orders, determining: a clinical trial study, a site location, and a treatment type; dispatching a first plurality of supply orders associated with a 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, at 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; and randomly dispatching a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits. In one or more examples, the method further includes, at the first computer system, confidentially 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 method further includes, at the first computer system: determining a shipping type of the first plurality of supply orders based on a determination that one or more of the supply orders are associated with a first shipping type; generating a shipping order for one or more of the supply orders associated with the first shipping type; and generating an instruction to store one or more of the supply orders associated with a second shipping type based on a determination that one or more of the supply orders are associated with the second shipping type. In some embodiments, the first shipping type corresponds to a pack-on-demand request, and the second shipping type corresponds to a pack-from-inventory request. In some embodiments, the method further includes receiving a request from a first clinical trial site associated with a first supply order among one or more of the supply orders associated with the second shipping type; and generating a shipping order for the first supply order based on the request from the first clinical trial site.

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

[0105] In some embodiments, the method further includes, at the first computer system: receiving an input from a client associated with a first clinical trial study, the input corresponding to an updated kit identifier 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 the plurality of kit identifiers are assigned to the first assembly order and the assembly order.

[0106] In some embodiments, the method further includes, at the first computer system, receiving a rejection from a user associated with the first computer system for the first assembly order, the second assembly order, or a combination thereof; and marking the rejected assembly order for a manual shipping process.

[0107] In one or more examples, embodiments of the present disclosure include an electronic system that includes one or more processors, a memory, and one or more programs, where the one or more programs are 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 for, at a first computer system that includes one or more processors and one or more memories: receiving a plurality of supply orders associated with one or more clinical trials; determining, for each of the plurality of supply orders: a clinical trial study, a site location, and a treatment type; and dispatching a first plurality of supply orders associated with a first clinical trial study to a packaging site 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 program 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 program based on the treatment type to create a second assembly order. In one or more examples, the one or more programs include instructions for, at a second computer system that includes a second one or more processors and a second one or more memories: receiving the first assembly order and the second assembly order; and randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits. In one or more examples, the one or more programs include instructions for, at the first computer system, confidentially generating a shipping order 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 programs further include instructions for determining, at a first computer system, a shipping type for a first plurality of supply orders; generating a shipping order for one or more supply orders associated with the first shipping type based on the determination of the association of the one or more supply orders with the first shipping type; and generating instructions for storing one or more supply orders associated with a second shipping type based on the determination of the association of the one or more supply orders with the second shipping type. In some embodiments, the first shipping type corresponds to a pack-on-demand request, and the second shipping type corresponds to a pack-from-inventory request. In some embodiments, the one or more programs further include instructions for receiving, at the first computer system, a request from a first clinical trial site associated with a first supply order among the one or more supply orders associated with the second shipping type; and generating a shipping order for the first supply order 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 customer communication or an application programming interface associated with the client.

[0110] In some embodiments, the one or more programs further include instructions for receiving, at the first computer system, an input from a client associated with a first clinical trial study, the input corresponding to an updated kit identifier 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 the plurality of kit identifiers are assigned to a first assembly order and an assembly order.

[0111] In some embodiments, the one or more programs further include instructions for receiving, at the first computer system, a rejection from a user associated with the first computer system for a first assembly order, a second assembly order, or a combination thereof; and marking the rejected assembly order for a manual shipping process.

[0112] 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: at a first computer system including one or more processors and one or more memories, receive a plurality of supply orders associated with one or more clinical trials; for each of the plurality of supply orders, determine: a clinical trial study, a site location, and a treatment type; based on the site location, assign a first plurality of supply orders associated with a first clinical trial study to a packaging site. In one or more examples, further cause the one or more electronic devices to: based on the treatment type, associate a first subgroup of the first plurality of supply orders with a first assembly procedure to create a first assembly order; and based on the treatment type, associate a second subgroup of the first plurality of supply orders with a second assembly procedure to create a second assembly order. In one or more examples, further cause the one or more electronic devices to: at a second computer system including a second one or more processors and a second one or more memories, receive the first assembly order and the second assembly order; and randomly assign a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits. In one or more examples, further cause the one or more electronic devices at the first computer system to confidentially generate shipping orders for the first plurality of clinical trials based on the plurality of blinded kits.

[0113] 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, further cause the one or more electronic devices to, at the first computer system, determine a shipping type of the first plurality of supply orders; based on the determination that one or more supply orders are associated with the first shipping type, generate a shipping order for the one or more supply orders associated with the first shipping type; and based on the determination that one or more supply orders are associated with a second shipping type, generate instructions for storing the one or more supply orders associated with the second shipping type. In some embodiments, the first shipping type corresponds to a pack-on-demand request, and the second shipping type corresponds to a pack-from-inventory request. In some embodiments, further cause the one or more electronic devices to, at the first computer system, receive a request from a first clinical trial site associated with a first supply order among the one or more supply orders associated with the second shipping type; and based on the request from the first clinical trial site, generate a shipping order for the first supply order associated with the second shipping type.

[0114] In some embodiments, the site locations of the first plurality of supply orders determined are associated with the same country. In some embodiments, the plurality of supply orders are received via customer communication or an application programming interface associated with the client.

[0115] In some embodiments, further cause the one or more electronic devices, at the first computer system, to receive an input from a client associated with a first clinical trial study, the input corresponding to an updated kit identifier 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, the updating of the plurality of kit identifiers is performed before the plurality of kit identifiers are assigned to a first assembly order and an assembly order.

[0116] In some embodiments, further cause the one or more electronic devices, at the first computer system, to receive a rejection from a user associated with the first computer system for the first assembly order, the second assembly order, or a combination thereof; and mark the rejected assembly order for a manual shipping process.

[0117] Although the present disclosure and examples have been described fully with reference to the accompanying drawings, it should be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications should be understood to be included within the scope of the present disclosure and examples as defined by the claims.

[0118] For purposes of explanation, the foregoing description has been made with reference to specific embodiments. However, the above illustrative discussion is not intended to be exhaustive or to limit the invention to the precise form disclosed. Given the above teachings, many modifications and variations are possible. The embodiments were chosen and described in order to best explain the principles of the technology and its practical application. Thereby, other skilled artisans are enabled to best utilize the technology and various embodiments with various modifications for the particular uses contemplated.

Claims

1. A method for confidentially generating a shipping order for a clinical trial, the method include: At a first computer system comprising one or more processors and one or more memories: receiving multiple supply orders associated with one or more clinical trials; determining, for each of the plurality of supply orders: a clinical trial study, a site location, and a treatment type; dispatching a first plurality of supply orders associated with a first clinical trial study to packaging sites based on site location; associating a first subset of the first plurality of supply orders with a first assembly procedure based on treatment type to create a first assembly order; and associating a second subset of the first plurality of supply orders with a second assembly procedure based on treatment type to create a second assembly order; At a second computer system comprising a second one or more processors and a second one or more memories: receiving a first assembly order and a second assembly order; and randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits; as well as At the first computer system, a shipping order is confidentially generated for a first plurality of clinical trials based on the plurality of blinded kits.

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

3. The method according to any one of claims 1 to 2, further comprising, at the first computer system: determining a shipment type for a first plurality of supply orders; Based on the determination that the one or more supply orders are associated with the first shipment type, generating a shipment order for the one or more supply orders associated with the first shipment type; and Based on a determination that the one or more supply orders are associated with the second shipment type, instructions are generated to store the one or more supply orders associated with the second shipment type.

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

5. The method according to any one of claims 3 to 4, further comprising: include: receiving a request from a first clinical trial site associated with a first supply order of the one or more supply orders associated with a second shipment type; and A shipping order is generated for the first supply order based on the request from the first clinical trial site.

6. A method according to any one of claims 1 to 5, 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 customer communications or an application programming interface associated with a client.

8. The method according to any one of claims 1 to 7, further comprising, at the first computer system: receiving input from a client associated with the first clinical trial study, the input corresponding to an updated kit identifier for one or more of the first plurality of supply orders; and The plurality of reagent cartridge identifiers associated with the first plurality of supply orders are updated.

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

10. The method according to any one of claims 1 to 9, further comprising, at 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; Flag rejected assembly orders for manual shipping process.

11. An electronic system, include: one or more processors; Memory; and One or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the one or more programs comprising instructions for: At a first computer system comprising one or more processors and one or more memories: receiving multiple supply orders associated with one or more clinical trials; Identify for each of multiple supply orders: the clinical trial study, site location, and treatment type; dispatching a first plurality of supply orders associated with a first clinical trial study to packaging sites based on site location; associating a first subset of the first plurality of supply orders with a first assembly procedure based on treatment type to create a first assembly order; and associating a second subset of the first plurality of supply orders with a second assembly procedure based on treatment type to create a second assembly order; At a second computer system comprising a second one or more processors and a second one or more memories: receiving a first assembly order and a second assembly order; and randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits; and At the first computer system, a shipping order is confidentially generated for a first plurality of clinical trials based on the plurality of blinded kits.

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 electronic system according to any one of claims 11 to 12, wherein the one or more programs may further include instructions for, at the first computer system: determining a shipment type for a first plurality of supply orders; Based on the determination that the one or more supply orders are associated with the first shipment type, generating a shipment order for the one or more supply orders associated with the first shipment type; and Based on a determination that the one or more supply orders are associated with the second shipment type, instructions are generated to store the one or more supply orders associated with the second shipment type.

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

15. The electronic system of any one of claims 13 to 14, wherein the one or more programs may further include instructions for, at 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 a second shipment type; and A shipping order is generated for the first supply order based on the request from the first clinical trial site.

16. The electronic system of any one of claims 11 to 15, wherein the determined site locations of the first plurality of assembly orders are associated with a same country.

17. The electronic system of any one of claims 11 to 16, wherein the plurality of assembly orders are received via customer communications or an application programming interface associated with a client.

18. The electronic system of any one of claims 11 to 17, wherein the one or more programs may further include instructions for, at the first computer system: receiving input from a client associated with the first clinical trial study, the input corresponding to an updated kit identifier for one or more of the first plurality of supply orders; and The plurality of reagent cartridge identifiers associated with the first plurality of supply orders are updated.

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

20. The electronic system of any one of claims 11 to 19, wherein the one or more programs may further include instructions for, at 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; Flag rejected assembly orders for manual shipping process.

21. A non-transitory computer-readable storage medium storing one or more programs, the one or more programs comprising 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: At a first computer system comprising one or more processors and one or more memories: receiving multiple supply orders associated with one or more clinical trials; Identify for each of multiple supply orders: the clinical trial study, site location, and treatment type; dispatching a first plurality of supply orders associated with a first clinical trial study to packaging sites based on site location; associating a first subset of the first plurality of supply orders with a first assembly procedure based on treatment type to create a first assembly order; and associating a second subset of the first plurality of supply orders with a second assembly procedure based on treatment type to create a second assembly order; At a second computer system comprising a second one or more processors and a second one or more memories: receiving a first assembly order and a second assembly order; and randomly assigning a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits; as well as At the first computer system, a shipping order is confidentially generated for a first plurality of clinical trials based on the plurality of blinded kits.

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 non-transitory computer-readable storage medium according to any one of claims 21 to 22, wherein the instructions further cause the one or more electronic devices, at the first computer system: determining a shipment type for a first plurality of supply orders; Based on the determination that the one or more supply orders are associated with the first shipment type, generating a shipment order for the one or more supply orders associated with the first shipment type; and Based on a determination that the one or more supply orders are associated with the second shipment type, instructions are generated to store the one or more supply orders associated with the second shipment type.

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

25. The non-transitory computer-readable storage medium according to any one of claims 23 to 24, wherein the instructions further cause the one or more electronic devices, at 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 a second shipment type; and A shipping order is generated for the first supply order based on the request from the first clinical trial site.

26. The non-transitory computer-readable storage medium of any one of claims 21 to 25, wherein the determined site locations of the first plurality of assembly orders are associated with a same country.

27. The non-transitory computer-readable storage medium of any one of claims 21 to 26, wherein the plurality of assembly orders are received via customer communications or an application programming interface associated with a client.

28. The non-transitory computer-readable storage medium of any one of claims 21 to 27, wherein the instructions further cause the one or more electronic devices, at the first computer system: receiving input from a client associated with the first clinical trial study, the input corresponding to an updated kit identifier for one or more of the first plurality of supply orders; and The plurality of reagent cartridge identifiers associated with the first plurality of supply orders are updated.

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

30. The non-transitory computer-readable storage medium of any one of claims 21 to 29, wherein the instructions further cause the one or more electronic devices, at 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; Flag rejected assembly orders for manual shipping process.

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