Clinical supply packs with electronic labeling

Abstract

Clinical supply packs may be provided with electronic paper labels that display updated information based on internal sensors and clinical supply pack inputs or communication with an external communication device, which is in communication with a central system. The displayed information may include multilingual data that is provided on the supply pack after it is sealed for distribution, and may include updated dosing regimens and clinical trial updates that are provided after distribution.

Description

[Background technology]

[0001] Pharmaceutical supply packages that carry pharmaceutical products are also known as medicine kits or clinical supply packs. For example, pharmaceutical products are often provided as tablets stored in individual sealed storage containers in a wallet, also known as blisters. To access the pharmaceutical products, patients typically open the package and slide it out of the wallet, thereby exposing the blisters. Individual pharmaceutical products are removed from each blister for consumption as directed.

[0002] The packages used in clinical trials can contain an active drug product or a placebo. Furthermore, the dose or concentration of the active drug product can vary between packages delivered to different patients according to the requirements of the clinical trial. Furthermore, the dose or concentration of the active drug product provided to an individual patient can vary from package to package, and even from tablet to tablet within the same package.

[0003] Traditionally, data associated with a package relied upon by a patient can be printed on a label on the packaging itself, or on a separate sheet that can be provided as an insert within the package, or can be otherwise carried by the package. The data can include the expiration date of the pharmaceutical product, safety information, storage information, instructions for consuming the pharmaceutical product, etc. It is recognized that the data is printed in accordance with the applicable regulations of the country to which the package is shipped. Thus, the data is printed in one or more languages ​​as required by the regulations of a particular country.

[0004] The information printed on the label may include other information such as the patient's name, clinician's name, serialization number, prescribed dosage, etc. In the case of clinical trials, such information may be handwritten. Summary of the Invention [Means for solving the problem]

[0005] Clinical supply packs may be provided with electronic labels, including electronic paper labels, that may be used in conjunction with an external communication device to perform supply pack labeling after packaging for distribution, whereby patient, safety, and / or clinical trial information may be added to the label, for example, after the packs are assembled and after the packs are collected into multipacks for shipment.

[0006] Electronic labeling can also be used for custom language displays tailored to patients and caregivers, in addition to regulatory required labeling. For example, information can be provided on a supply pack for display in three languages, with the information in a first language displayed to meet regulatory requirements in the country or region where the patient is receiving treatment. Information can also be displayed in a second or third language, as selected by the user of the supply pack.

[0007] Electronic labeling can be used for dynamic presentation of static information, for example, to browse through multi-page information, and can be used to display dynamic information such as expiration dates, storage conditions, or directions for use of clinical materials.

[0008] Electronic labeling can be used to change information during use of the supply pack by the client, for example, whereby dosing regimen or other protocol information is provided or changed, for example, by the attending physician or clinical investigator, and the new information is displayed on the supply pack itself.

[0009] Electronic labeling can be used to redirect or reuse clinical materials by providing new patient, safety, and / or clinical trial information at any time, including after manufacturing, after distribution, and during distribution, and after dispensing to patients, for example.

[0010] The continued use, diversion, and reuse of clinical materials may be contingent on use and storage information collected by supply packs or other equipment and systems.

[0011] This Summary is provided to introduce a selection of concepts in a concise form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended for use in limiting the scope of the claimed subject matter. Moreover, the claimed subject matter is not limited to limitations that solve any or all disadvantages noted in any part of this disclosure. [Brief explanation of the drawings]

[0012] A more detailed understanding may be had from the following description, given by way of example in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a block diagram of an exemplary pharmaceutical supply life cycle. [Figure 2] 1 is an example of information on a label for a pharmaceutical supply. [Figure 3] Here is an example of a Canadian label in English. [Figure 4] An example of a Canadian label in French. [Figure 5] Examples of Israeli labels in Hebrew, Russian and Arabic. [Figure 6] FIG. 1 is a block diagram of an exemplary clinical supply pack. [Figure 7] FIG. 1 is a block diagram of an exemplary system including multiple supply packs in a multipack, a communication device, and a central system. [Figure 8] 1 is a call flow of an exemplary set of interactions between a clinical supply pack, a supply pack communication device, and a central system. [Figure 9] FIG. 1 is a block diagram of an exemplary communication device. [Figure 10] FIG. 1 is a block diagram of an exemplary computing device. DETAILED DESCRIPTION OF THE INVENTION

[0013] Intelligent packaging and management for clinical supplies, including clinical trial materials, is disclosed. FIG. 1 is a block diagram of an exemplary pharmaceutical supply lifecycle. Pharmaceutical materials, packaging, and labels are combined into clinical supply packs at a pack and label facility. The packs are typically sealed at the end of production, e.g., with a quality seal, shrink-wrap, etc. Traditionally, supply packs may include printed materials containing, e.g., detailed storage, use, safety, and other materials. During the distribution phase, sealed supply packs may travel from a distribution center to a depot, then to a distribution site, and ultimately to a patient. Alternatively, supply packs may be sent, for example, from a distribution center directly to a site or patient, or from a depot directly to a patient.

[0014] At the distribution stage, the supply pack remains sealed before being distributed for use by patients. It is opened for use by patients. Used supply packs can be collected by the site, for example, for analysis or for transport for safe disposal of used material.

[0015] FIG. 2 is an example of information on a label for a pharmaceutical supply. In FIG. 2, the label is for a clinical trial supply pack. In this example, the label identifies the pharmaceutical product contained in the pack, for example, by its product name or other identifier, the amount of product in the pack, and the dosage form. Safety information, including storage and handling instructions, is listed, as well as instructions for keeping out of reach of children, whether the pack is child / tamper-resistant, and instructions for disposal of any unused product. In the case of a clinical trial, the label may include information regarding the protocol number or other identifier, medication number, reference number, route of administration, the global sponsor of the trial, and the local sponsor of the trial. In the case of prescription drugs not involved in a clinical trial, the label may alternatively include information such as the name of the prescribing physician, dispensing pharmacy, etc., as well as the patient's name. In the example of FIG. 2, the patient is identified by a subject number, and the physician is the principal investigator or clinical investigator. The label further includes an expiration date and dosing instructions.

[0016] In the example of Figure 2, similar to traditional clinical trial labels, the subject number and investigator name are left blank to be filled in manually at the time of distribution.

[0017] Managing this data presents many challenges in coordinating pharmaceutical manufacturing, distribution, and distribution. For example, in practice, all information on such labels may need to be translated into other languages. This includes variable information, such as the representation of month codes in expiration dates. Some content is country-specific or specific to the local sponsor. Some countries may require more content than others. For example, Germany requires the eudrag number in German. Some countries require certain statements in multiple languages ​​on the same label. For example, Israel requires information to be presented in English, Hebrew, Arabic, and Russian on the same label. Figure 3 is an example of a Canadian label in English. Figure 4 is an example of a Canadian label in French. Figure 5 is an example of an Israeli label in Hebrew, Russian, and Arabic. Serial numbers, such as the two-dimensional barcodes shown in the examples of Figures 3, 4, and 5, can be determined during manufacturing. Traditionally, in the case of clinical trials, protocol identification is determined when clinical supply packs are assigned to the protocol. In the case of pooling, this can occur anywhere in the process between the manufacturing of the clinical supply packs (earliest) and the distribution of the clinical supply packs to patients (latest).

[0018] Information provided with clinical supply packs, including label information, may change at any time. Practices for changing labeling information vary, for example, from country to country, and practices are evolving.

[0019] Electronic labeling allows for many options for both better initial labeling and updating label information at any point in the supply pack lifecycle. Additionally, clinical supply packs can be configured to independently adjust their own labels, with or without the assistance of external devices, depending on conditions such as use, environment, and the passage of time.

[0020] For example, a serial number or other identifier may be displayed on the electronic label, such as as a bar code or in other format. Bar code serial numbers are commonly used to facilitate the manufacture, distribution, and distribution of clinical supply packs. However, with electronic labeling, the serial identifier of a clinical supply pack need not be static.

[0021] Traditionally, in clinical trials, the identity of the investigator is determined when dispensing a clinical supply pack to a patient. With electronic labeling, the association of a clinical supply pack to a patient, trial, or investigator can be identified at any point in its lifecycle, and the label can be adjusted accordingly. Reassignment to different protocols is possible.

[0022] Traditionally, patient identity is determined when a clinical supply pack is distributed to a patient. Because clinical supply packs are generally not manufactured for a specific patient, there is no patient-related label information available prior to distribution. However, with electronic labeling, patient-specific clinical supply packs can be manufactured at a pack and label facility, or at a distribution center or depot. Typically, once a clinical supply pack is labeled for use by a first patient, it cannot be relabeled for use by a second patient. However, with electronic labeling, this is possible, which can be valuable, for example, to retrieve rare or valuable clinical supplies that are in good condition for transfer to a second patient.

[0023] Dosing instructions may have already been determined during manufacturing. However, dosing can also be determined only at the time of distribution to the patient. For example, based on specific patient criteria, one of many possible dosing regimens may be selected by the physician / investigator, such as more or fewer tablets per dose depending on the patient's age or weight.

[0024] Similarly, electronic labeling allows for the change of the displayed information in one or more languages ​​depending on where the clinical supply is currently physically located, where it is being sent, and where it travels along the way. Even after distribution, patients or caregivers may prefer to have the information made available in different languages ​​on the clinical supply pack electronic label. The language, format, and content of the information displayed on the electronic label can be changed at any time, allowing the determination of where and by whom the clinical supply pack will be used to be dictated or changed at any point in the product lifecycle.

[0025] Referring to FIG. 6 , a clinical supply pack 100 includes a clinical supply 110 of pharmaceutical dosage units 112. The clinical supply pack 100 can be configured as a smart supply pack having a usage sensor 114 that can be configured to detect the removal of a dosage unit 112 from the clinical supply pack. For example, the clinical supply 110 can take the form of a blister pack, e.g., a plastic tray having an array of cavities with a foil lining that seals a dose of medication, such as a tablet or capsule, within each cavity. In this case, the usage sensor 114 can simply be a wire that is broken by breaking the foil near the cavities to allow removal of the dosage unit 112. The supply pack 100 can include a controller 136, which can be a digital computing processor, used to control the operation of various components of the supply pack. For example, the controller 136 can be configured to determine either or both of the number and location of dosage units 112 removed from the clinical supply 110.

[0026] The usage sensor 112 can be used by the controller 136 to collect usage information, including which doses are used and when they are used.

[0027] Alternatively, the clinical supply 110 may be an array of dosage units 112 in the form of, for example, vials, syringes, or applicators containing liquid, powder, or gel material, and the usage sensor 114 detects, for example, the removal and / or level of material remaining in a vial or the like.

[0028] Additionally, clinical supplies 110 may include a set of clinical supplies. For example, clinical supplies 110 may include a combination of items such as pharmaceutical dosage units, swabs, test strips, sample containers, needles, etc., used for the execution of a medical protocol over a period of time, such as compliance with a protocol during a course of treatment or medical test.

[0029] In practice, supply pack 100 may include one or more processors, or controllers. Alternatively, or additionally, supply pack 100 may include at least one processor integrated into various components of supply pack 100 in addition to, or instead of, a main controller. Similarly, in the example of Figure 6, supply pack 100 includes memory that may be used to store information and executable code used by controller 136.

[0030] In practice, supply pack 100 may have digital memory incorporated into various components of supply pack 100 in addition to, or instead of, main memory 138. It should be understood that the processor and memory functions may be implemented in any number of ways, using a variety of technologies including ROM and RAM memory, and / or structures such as dedicated execution hardware, such as gate arrays, including field programmable gate arrays, etc.

[0031] In the example of FIG. 6 , supply pack 100 may further include antenna 120 through which it may receive signals via air interface 122. Air interface 122 may include an energy harvester that extracts energy incident on supply pack 100 for use in the electronic operation of supply pack 100. For example, antenna 120 may be a wireless antenna operating in the near-field communication (NFC) band and extracting both energy and power therefrom. However, it should be understood that supply pack 100 may alternatively use any type of wired or wireless communication technology, such as, for example, Bluetooth, an infrared link or other optical link, or wired serial communication. Non-line-of-sight communication may be preferred to facilitate use in distribution channels and patient care areas.

[0032] The clinical supply pack 100 may have multiple air interfaces. For example, it may have a first interface communicating with a communication device via WiFi and a second interface through which it communicates with other clinical supply packs via near field communication, or vice versa. Furthermore, the clinical supply pack may operate in a mesh network, a self-organizing network, a master-slave network, or the like.

[0033] Although not shown in FIG. 6, supply pack 100 may have other power sources, such as one or more batteries, a solar power panel, and / or a magnetic coupler to the base in which the supply pack is stored.

[0034] Controller 136 may communicate with various other components of supply pack 100, which may include usage sensor 114, environmental sensors 116 and 118, air interface 122, memory 138, e-label 130, input 132, and output 134. Controller 136 may perform operations to store, retrieve, and transmit information to and from various other components and external devices via air interface 122.

[0035] Executable code stored in controller 136, air interface 122, and / or memory 138 may cause supplies 100 to implement security protocols to prevent unauthorized access to supplies 100 via air interface 122. For example, supplies 100 may be configured to allow access to or modification of stored information according to a user's security level and / or authorization of a user, such as a patient.

[0036] In the example of FIG. 6 , the supply pack 100 includes environmental sensors 116 and 118 that may be included to monitor the environment of the clinical supply 110 during distribution and / or use. The environmental sensors may be located proximate the clinical supply 110 or elsewhere within the supply pack 100 and may be used to detect conditions related to the storage or administration of the dose units 112. Any number of environmental sensors may be used. For example, the environmental sensor 116 may be a temperature sensor and may include logging functionality to store records of temperatures at various times and / or excursions above safe storage or use temperatures. The environmental sensor 118 may be a vibration sensor useful for monitoring the movement of the supply pack 100 to detect deviations from safe handling that may lead to separation of the dose unit 112 materials, such as colloids or suspensions. Additionally, the environmental sensors may be used to detect exposure to visible or UV light, or other radiation, or humidity, that may lead to degradation of the dose unit 112 materials within the clinical supply 110, for example. Data from environmental sensors 116 and 118 may be evaluated by controller 136 to determine the suitability of dosage units 112 in clinical supply 110 for use, such as whether the dosage units are expired, unsafe, or deemed suitable for current use. Data from environmental sensors 116 and 118 may be stored in memory 138 by controller 136 or provided to an external device via air interface 122, e.g., from memory 138 via controller 136, or directly from environmental sensors 116 and 118, either as part of periodic reports or upon request from an external device.

[0037] Supply pack 100 includes one or more electronic displays, which may be configured as electronic labels (or e-labels) 130, capable of displaying information including human-readable text. For example, e-labels 130 may be LCD displays or other forms of electronic paper. E-paper may offer particular advantages in that it can contain and display large amounts of information that remains visible when power is removed, for example.

[0038] The e-label 130 may further be used to display machine-readable codes such as barcodes, including two-dimensional barcodes. For example, safety information may include a barcode displayed on the e-label 130, whereby a user may scan the barcode with a mobile computing device to obtain a web link for further information.

[0039] The e-label 130 can be used to display both dispensing information and safety information. Dispensing information can include, for example, patient identification, medication name, dosing regimen, and expiration date of the dosage unit 112. The dosing regimen can include, for example, regularly scheduled dosing times and amounts, suggested amounts and limits for use as needed, etc. Safety information can include, for example, instructions for administration, contraindications, potential side effects to watch for, and any other useful information or required disclosures.

[0040] The e-label 130 may be used to display additional clinical trial information, such as a study protocol indicator, a randomization code, and information identifying the clinical investigator. The study protocol indicator may be a number, code, or name referring to the entity conducting the study and / or documentation of the parameters of the study in which the patient is enrolled. Information identifying the clinical investigator may include the name or other identifier of the physician, group of physicians, institution, or team responsible for overseeing the clinical study.

[0041] Labeling of supply packs after packaging For example, in contrast to the printed labels and information used on traditional clinical supply packs, the information to be included on an individual supply pack 100, including the e-label 130, can be programmed after the supply pack 100 is sealed and packaged for shipment. That is, the visible indicia on the e-label 130 can be electronically changed at any point in the supply chain after packaging or during use. This is highly advantageous for improving logistics, as clinical materials do not need to be combined with printed materials prior to distribution and dispensing. A single inventory of unordered supply packs can be maintained and then ordered per specific requirements at the time of distribution, shipping, or distribution.

[0042] For example, a single supply of supply packs may be maintained in a first country and distributed equally to various countries, including through shipments through various other countries. In particular, one or more supply packs, which may be included in a supply pack carton, may be sent, for example, from a first country to a second country and ultimately to a third country, and need not be labeled in the native language of the first or second country. Nor does the shipper in the first country need to know in advance whether the package is destined for a third country. Rather, each supply pack may be ordered with the required labeling information in the language of the third country either upon shipment from the first country, upon receipt in the third country, or upon distribution. It is recognized that supply packs may be sent from a first country to a second country, with the second country defining the destination country.

[0043] Custom Language and Multilingual Display Human-readable information can be loaded onto the supply pack in any language or multiple languages ​​and displayed on the e-label 130. For example, in the case of a clinical trial or recall, safety information or administration instructions can be updated in the field long after the manufacture of the supply pack 100. For example, when the supply pack 100 is distributed for use by a patient, the information can be loaded in the language preferred by the patient, the attending nurse or aide, and / or the attending physician, in addition to any languages ​​required by local law.

[0044] User selection of information for display The supply pack 100 can be arranged to change what information is displayed on the e-label 130 in response to changing conditions or user requests. For example, the supply pack 100 can include an input 132, such as a momentary contact or capacitance-sensing switch, that triggers an action by a controller. The input 132 can have a dedicated function, such as browsing up or down when the e-label 130 presents a portion of multiple pages of information. Alternatively, the interpretation of the input activation can depend on the text or images displayed and / or highlighted on the e-label 130. For example, the input 132 can be used to zoom in on dosage or administration information, or page down through multiple pages of safety information, or select a link within the displayed information to go to specific information of interest, such as a web page, rather than requiring the user to search for small print safety information within a large sheet.

[0045] Similarly, inputs 132 may be used to select different languages ​​for display of information. For example, a first input may be activated by the user to signal controller 136 to change which language in the list of languages ​​is highlighted, and a second input may be activated by the user to indicate to controller 136 that display in the currently highlighted language is preferred by the user.

[0046] Multiple e-labels 130, or multiple sections of a single e-label 130, may be used to separately display static information in accordance with local regulatory requirements and information selected by the user using input 132, for example.

[0047] Displaying Dynamic Information Similarly, the e-label 130 can display newly received or newly discovered information with the supply pack 100. For example, the e-label 130 can be used to display the status of the clinical supply 110. In one example, the status of the clinical supply 110 can be, for example, the number of dosage units 112 removed or remaining in the clinical supply, as sensed by the usage sensor 114 and communicated from the usage sensor 114 to the controller 136. Similarly, the e-label 130 can display dynamic information, such as the expiration date of a dosage unit 112, either due to the passage of time, e.g., past the expiration date, or due to one or more environmental conditions, e.g., exposure to heat, vibration, humidity, or light, exceeding safe limits as detected by one or more environmental sensors 116 and 118. Additionally, an output 134, such as an LED indicator, may be used to indicate the status of the clinical supply 110, for example, showing green when the clinical supply 110 is ready for use and red when the clinical supply 110 has expired or is otherwise determined to be unsuitable for current use.

[0048] Relabeling after patient distribution The e-label 130 can further display updated information even after one or more dosage units 112 have been removed for consumption by the patient. For example, the supply pack 100 may communicate with a mobile communication device, such as a patient's or caregiver's mobile phone, via the air interface 122 and antenna 120 to receive updated dosing information (e.g., changes to the amount of medication administered and the timing of dosing), administration instructions (e.g., changes to how the dosage unit is to be used, such as before or after meals, changes to information to be recorded when using clinical supplies), or safety information (e.g., new contraindications or side effects to be aware of). The received information can then be displayed on the e-label 130. Similarly, product recall information received by the supply pack 100 via the air interface 122 can be displayed on the e-label 130.

[0049] Multi-pack operation 7, a communication system 200 may include at least one supply pack 100, a communication device 220 external to the supply pack 100 and configured to communicate with the at least one supply pack 100, and a central system 240 configured to communicate with the communication device 220 via a network 230. The at least one supply pack 100 may be provided individually or in a multi-pack 210 including multiple supply packs 100, such as supply packs 100A, 100B, and 100C. The supply packs may be configured as described above with respect to FIG.

[0050] The multipack 210 may be a shipping box, such as a cardboard box or a plastic distribution tote, used for the common transport of different clinical supply packs 100, with an additional shipping label that does not include medication labeling information, such as the information illustrated in Figures 2-5.

[0051] Alternatively, multi-pack 210 may be an assembly containing multiple supply packs 100, all bearing medication labeling such as the information shown in FIGS. 2-5, for example, if the clinical supply packs 100 are intended to be distributed together for use by a single patient. In this case, the clinical supply packs 100 may be essentially identical, e.g., containing doses of the same medication to be used throughout the course of treatment. Alternatively, clinical supply packs 100 may each contain different clinical supplies, e.g., with a set of billing slips in clinical supply pack 100A, a set of injectable medications in clinical supply pack 100B, and a set of specimen collection supplies in clinical supply pack 100C. Furthermore, multi-pack 210 may contain nested sets of clinical supply packs, e.g., with clinical supply pack 100A bearing a master label and clinical supply packs 100B and 100C physically contained within clinical supply pack A, each with its own label in addition to the label of clinical supply pack A. Multi-pack 210 may include tiers of supply packs in multiple layers to facilitate organized distribution of supplies over the course of treatment, for example, with individual labeling, tracking, etc. for each pack in a tier.

[0052] An external device, which may be a communications device 220, may be in communication with one or more of the supply packs 100. For example, the communications device may communicate wirelessly with one or more of the supply packs 100. The communications device 220 is also in communication with a central system 240 via a network 230. The network 230 may be any suitable wireless or other data communications network.

[0053] Communications device 220 is specially adapted for use with supply packs 100A, 100B, and 100C and / or central system 240 through specialized hardware, data, or software. For example, communications device 220 may have a radio-frequency identification (RFID) reader for communicating with supply pack controller 136. Communications device 220 may be provided with credentials or other information necessary to establish secure communications with supply packs 100A, 100B, and 100C and / or central system 240. Communications device 220 may use software applications or web services that enable it to communicate with supply packs 100A, 100B, and 100C and / or central system 240. For example, credentials and software may be tailored for use in a particular healthcare system, clinical setting, or clinical study, for example.

[0054] In the example of FIG. 7 , communication device 220 may belong to a user, such as a patient or a caregiver for the patient. While communication device 220 may be configured as a cellular telephone, such as a cellular phone application, it should be understood that communication device 220 may alternatively be any suitable mobile computing device, such as a tablet, laptop, or scanner, or a stationary computer, such as a desktop or industrial fixture. Preferably, communication device 220 communicates with multipack 210 and / or supply pack 100 via a non-line-of-sight wireless link 222, but may alternatively use, for example, infrared or a wired connection. Thus, communication device 220 may communicate with multipack 210 via a non-line-of-sight or line-of-sight wireless data communication link 222. Alternatively, communication device 220 may communicate with multipack 210 via one or more data communication lines.

[0055] 7, communication device 220 communicates with network 230 via wireless link 232, and network 230 communicates with central system 240 via wireless link 234. For example, link 232 can be a WiFi, Bluetooth, or cellular communication link, and link 234 can also be a similar or different link. In practice, any wireless, wired, optical, or other computer connection can be used, and network 230 and central system 240 can be arranged in a variety of ways. For example, network 230 can include both a local WiFi gateway and the Internet, and central system 240 can include a manufacturer's corporate system and a network of devices, including computers used by clinical investigators, pharmacists, and attending physicians.

[0056] 7 embodiment, multipack 210 may include couplers 212, which may include, for example, active or passive antenna devices that serve to couple or relay signals between supply packs 100 and communications device 220 and / or from supply pack to supply pack. Communications device 220 may communicate directly with one or more supply packs 100, or with one or more couplers 212, which in turn may communicate with one or more supply packs 100 or otherwise relay signals.

[0057] System 200 may be used in a variety of scenarios. System 200 may be used during manufacturing, e.g., when components of a supply pack 100 are brought together. System 200 may be used during distribution, e.g., when supply packs are stored and shipped singly or in multi-packs 210. System 200 may be used during distribution, e.g., when one or more supply packs 100 are given by a pharmacy for use by a particular patient, e.g., at a clinical setting or a dispensing pharmacy. System 200 may be used during use of a supply pack 100 by a patient, e.g., to provide updated information to the patient and others via display on e-label 130 and to allow information to be collected from the supply pack 100 to communication device 220 and central system 240. System 200 may be used in post-use analysis, e.g., after the used supply pack 100 has been collected from a treatment area, e.g., for extraction of environmental sensor data or test materials or samples stored within the supply pack 100. The system 200 can be used to relabel unused supply packs 100 .

[0058] It should be noted that different information for different supply packs may be provided on the supply packs after they have been combined in multi-pack 210. This may occur at any point in the lifecycle of clinical supply pack 100. For example, supply packs 100A and 100B may be provided with information for a first patient, while supply pack 100C may be provided with information for a second patient. Similarly, supply packs 100A and 100B may be labeled, for example, for first and second treatments of the same patient.

[0059] In addition to having different patient identification information and different dosing information, one or more of supply packs 100A, 100B, and 100C may be identified for use in a different country than at least one other of supply packs 100A, 100B, and 100C. Thus, in accordance with local regulatory requirements, one or more of supply packs 100A, 100B, and 100C may have different information than at least one other of supply packs 100A, 100B, and 100C. The different information may include at least one or more, up to and including, a different expiration date, different handling requirements, different administration instructions, and / or, if applicable, a different clinical trial investigator, protocol, and randomization kit number. Furthermore, the different information may be displayed in a different language or set of languages ​​on each of supply packs 100A, 100B, and 100C.

[0060] Information about each of the supply packs 100 may be passed directly from the communication device 220 to an intended supply pack 100 of the plurality of supply packs 100, e.g., via wireless link 222. Similarly, information about each pack may be passed to the intended supply pack 100 via one or more intermediate packs or couplers, or a combination thereof. For example, information about intended supply pack 100B may be received by supply pack 100B from intermediate supply pack 100A via link 224 between supply packs 100A and 100B. Alternatively, information about intended supply pack 100B may be received from intermediate supply pack 100A, or indirectly, e.g., first via link 222 from communication device 220 to coupler 212, and from coupler 212 via link 226 to supply pack 100A or 100C, and then, e.g., from supply pack 100A or 100C to supply pack 100B.

[0061] Information gathered by individual supply packs 100 may be collected by communication device 220 and then processed by communication device 220 and / or forwarded to central system 240 for processing. For example, the collected information may include usage sensor data, environmental sensor data, and inputs made by a user via input switches, along with the context of the information displayed when the input was made by the user.

[0062] Updates may be passed from communication device 220 to supply pack 100 based on information from communication device 220, central system 240, or in response to information received from supply pack 100. For example, updates may include modified dosing, dosage administration, and / or safety information. Additionally or alternatively, updates may include new expiration dates or new limits for determining when environmental sensor readings exceed safety requirements.

[0063] The central system 240 may pre-locate information intended for a particular supply pack 100 or set of supply packs 100, so that the information is first transferred to, and later transferred from, the communication device 220 and then communicated with the particular supply pack 100 or set of supply packs 100. Similarly, the supply pack 100 may store information in anticipation of establishing a connection with the communication device 220. The communication device 220 may communicate with the at least one supply pack 100 when the communication device 220 is brought within a predetermined proximity range of the at least one supply pack 100. Alternatively, or additionally, a user may select an input on one or both of the communication device 220 and the at least one supply pack 100 that establishes a connection between the communication device 220 and the supply pack 100.

[0064] In one example, the supply pack 100 may be a passive supply pack that does not include an independent power source, such as a battery. Rather, the passive supply pack 100 may be powered by obtaining energy from a short-range wireless communication link with the communication device 220. Thus, the passive supply pack 100 may not have the ability to run a clock to independently determine the passage of time. However, the supply pack 100 may have a record of the expiration dates of the pharmaceutical dosage units 112 and may receive time and date information from the communication device 220 upon connection with the communication device 220. The supply pack 100 may then determine that the clinical supply 100 has expired and alter the display of the e-label 130 accordingly. Similarly, the supply pack 100 may use the energy and / or processing power of the communication device 220 upon connection to evaluate data from the usage sensor 114 and / or one or more environmental sensors 116 and 118 and make determinations regarding the status of the clinical supply 110.

[0065] Similarly, the supply pack may register a request for information or a request to record a status received from a user via input 132 on the supply pack 100 and then forward the information to the communication device 220 when the supply pack 100 is connected to the communication device 220. The request may be processed by the communication device 220 or communicated from the communication device 220 to the central system 240. For example, a user may request information in a language not originally provided on the supply pack 100 at the time of dispensing, and the supply pack may later request such information when connecting to the communication device 220. The communication device 220 may then provide the information immediately or after requesting and receiving the information from the central system 240.

[0066] In other examples, the supply pack 100 may be an active supply pack that has a power source and can independently determine the passage of time, and therefore can determine when the expiration date of a pharmaceutical dosage unit 112 has been reached without communicating with the communication device 220, and communicate that determination to the communication device 220.

[0067] Relabeling of unused clinical materials after distribution A supply pack 100 with an e-label 130 may be distributed to a second patient even after the supply pack 100 has been distributed for use by a first patient. In contrast, dispensed clinical materials with printed labels generally must be destroyed if not used by the patient to whom they are distributed. Electronic labeling allows the communication device 220 to communicate with the supply pack 100, for example, in accordance with a communications security protocol, to retrieve information regarding the use and safety of the clinical supply 110, as determined by the usage sensor 114 and environmental sensors 116 and 118, for example. Additionally, via input 132, the processor may have information provided by a user that the supply pack 100 is defective in some way. If the external device satisfies and / or the processor 136 satisfies that the supply pack 100 is in good condition, new patient information, safety information, and / or clinical trial information may be downloaded to the supply pack 100 and displayed by the supply pack 100 on the e-label 130.

[0068] Communication Flow Referring now to Figure 8, an exemplary communication flow 300 is shown that may be applied in many situations. For illustrative purposes, the supply pack 100 of Figure 8 is similar to that discussed with respect to Figures 1 and 2, and the communication device 220 and central system 240 are as described in connection with Figure 7.

[0069] Communication flow 300 may include step 301, in which supply pack 100 may make observations of its condition, for example, through observation of usage sensor 114, environmental sensors 116 and 118, and input 132. The observations may include the time input 132 was activated and / or what was displayed on e-label 130 at the time input 132 was activated. For example, the meaning of input 132 may change based on whether input 132 was activated in response to a prompt to select a language for display, a link to more information, or a selection on a multiple-choice prompt regarding the patient, the condition, or the manner in which the dose is administered. Similarly, supply pack 100 may make observations regarding environmental sensor readings, environmental sensor readings outside of secure storage requirements, the duration for which readings were observed, or a combination thereof.

[0070] In step 302, the central system 240 may pre-position information on the communication device 220. For example, the central system 240 may send information to the communication device in anticipation of one or more supply packs 100 being shipped by a distributor and / or received at a pharmacy. This obviates the need for a live connection between the communication device 220 and the central network 240 when labeling and / or configuring the supply packs 100.

[0071] In step 304, communications device 220 is placed in communication with supply pack 100. In one embodiment, communications device 220 may initiate communications with supply pack 100. For example, communications device 220 may send a broadcast to discover supply packs within range, then negotiate a connection with any supply packs it discovers, and form a secure link to any supply packs it wishes to configure. Communications device 220 may transmit initial information regarding its identification, authentication, time and date, etc. Alternatively, supply pack 100 may initiate communications with communications device 220.

[0072] Once the communication device 220 and the supply pack 100 are in communication with each other, the supply pack may send a status report to the communication device 220 in step 306. The status report may include items such as supply pack identification and authentication, current order information, if any, such as patient, safety, and clinical trial information, expiration dates, information from any of the sensors, user input, and / or requests for information of the types described above.

[0073] In step 308, in response to information in the initial connection or status report, communication device 220 may request information from central system 240. For example, if a user of the supply pack indicates, e.g., via actuation of input 132, a request for a display in a language not currently available on supply pack 100 or for other information associated with a selected link displayed on e-label 130, and such information is not available on communication device 220, communication device 220 may request the information from the central system.

[0074] Alternatively, or additionally, in step 308, the communication device 220 may report information received from the supply pack 100 to the central system 240, such as expiration, usage, or status of the clinical supplies 110 in the supply pack 100.

[0075] In step 310, the central system 240 may send information updates to the communication device 220, e.g., to respond to one or more requests by the supply pack 100 with requested information, to otherwise transmit information desired to be communicated to the supply pack 100, or to otherwise respond to the status of the supply pack 100 and still transmit data to the supply pack 100. The information can be sent from the central system 240 to the communication device 220, which in turn transmits the information to the supply pack 100 when the communication device 220 is in communication with the supply pack 100. For example, the central system 240 may notify the communication device 220 that a supply pack 100 labeled for a first patient should be diverted to a second patient, marked for destruction or returned for analysis, or provided with other information, such as updated safety, dosage, language, administration, clinical studies, or an updated expiration date for the pharmaceutical dosage unit 112.

[0076] Similarly, the central system 240 may notify the communication device 220 of the product status of the supply pack 100. The product status may indicate, for example, whether the supply pack 100 is suitable or unsuitable for use. Additionally or alternatively, the product status may include information regarding product recalls, expiration dates, or other conditions that affect the suitability of the supply pack 100. The supply pack 100 may display the product status on an electronic label. Alternatively, the supply pack 100 may use the product status to determine how to adjust its labeling, for example, how to display expiration notifications in a preferred language based on the product status, the record of preferred language, and the selection of available label messages.

[0077] In step 312, the communication device 220 provides patient, safety, and / or clinical trial labeling information, as well as information for monitoring inputs and / or sensors, managing displays, and activating outputs, to the supply pack 100. Such information may come from the central system 240 or from other sources, such as the user interface of the communication device 220.

[0078] For example, the supply pack may have a unique identifier, e.g., associated with the supply pack's controller 136, that may be used in establishing secure communications between the supply pack 100 and the communication device 220 and to identify the supply pack 100 to the central system 240. Alternatively, or additionally, the supply pack 100 may be ordered by the communication device using the serialization information for display on the e-label 130 and for quality control tracking purposes.

[0079] In step 314, the supply pack 100 may send a confirmation that all of the ordering information was properly received.

[0080] In step 316, the communication device 220 may send confirmation to the central system that the supply pack 100 has been ordered according to the pre-positioning or updated information provided by the central system 240.

[0081] Variations The flow 300 of FIG. 8 may be followed at different times with different equipment fulfilling the different roles of the communication device 220 and the central system 240. For example, during manufacturing, the communication device 220 may be industrial equipment at a pharmaceutical manufacturing facility, and the central system may be part of an enterprise computing system. During distribution, for example, at a warehousing facility that handles storage and shipping of supply packs, the communication device 220 may be a desktop computer. When the supply pack 110 is delivered to a pharmacy for subsequent delivery to a user, the communication device 220 may be, for example, a barcode scan gun enhanced with near-field wireless capabilities that operates in conjunction with the pharmacy's checkout system. When the supply pack 110 is delivered to a user for retrieval and consumption of the pharmaceutical dosage units 112, the communication device 220 may be a cell phone or other mobile device belonging to the user, such as a patient, or a caregiver, such as a primary care physician. The central system 240 may be based, for example, at a centralized facility overseeing a set of international clinical trials, or on the laptop computer of a clinical investigator at a single site. It should be appreciated that many arrangements of computing equipment can be used to implement the techniques described herein.

[0082] Exemplary Computing Device Figure 9 is a block diagram of an example apparatus 400 that may be configured for wireless communication and operation in accordance with the systems, methods, and apparatus described herein, such as the communication device 220 of Figures 7 and 8. As shown in Figure 9, the example apparatus 400 may include a processor 440, a transceiver 420, a transmit / receive element 422, a speaker / microphone 424, a keypad 426, a display / touchpad / indicator 428, non-removable memory 430, removable memory 432, a power source 434, a global positioning system (GPS) chipset 436, and other peripherals 438. It should be understood that the apparatus 400 may include any subcombination of the foregoing elements.

[0083] The processor 440 may be a general-purpose processor, a special-purpose processor, a conventional processor, a digital signal processor (DSP), multiple microprocessors, one or more microprocessors in association with a DSP core, a controller, a microcontroller, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) circuit, any other type of integrated circuit (IC), a state machine, etc. The processor 440 may perform signal coding, data processing, power control, input / output processing, and / or any other function that enables the device 400 to operate in a wireless environment. The processor 440 may be coupled to the transceiver 420, which may be coupled to the transmit / receive element 422. While FIG. 9 depicts the processor 440 and the transceiver 420 as separate components, it should be understood that the processor 440 and the transceiver 420 may be integrated together in an electronic package or chip.

[0084] In practice, device 400 may have multiple transceivers and / or antennas or communications in multiple frequency bands, such as, for example, near field and other RFID frequencies, BlueTooth, WiFi, and cellular communication bands.

[0085] Processor 440 of device 400 may be coupled to and receive user input data from speaker / microphone 424, keypad 426, and / or display / touchpad / indicator 428 (e.g., a liquid crystal display (LCD) display unit or an organic light-emitting diode (OLED) display unit). Processor 440 may also output user data to speaker / microphone 424, keypad 426, and / or display / touchpad / indicator 428. Additionally, processor 440 may access information from and store data in any type of suitable memory, such as non-removable memory 430 and / or removable memory 432. Non-removable memory 430 may include random-access memory (RAM), read-only memory (ROM), a hard disk, or any other type of memory storage device. Removable memory 432 may include a subscriber identity module (SIM) card, a memory stick, a secure digital (SD) memory card, etc. Processor 440 may access information from and store data in memory that is not physically located on device 400, such as on a server hosted in a cloud or edge computing platform or a home computer (not shown).

[0086] Processor 440 may receive power from power source 434 and may be configured to distribute and / or control power to other components within apparatus 400. Power source 434 may be any suitable device for providing power to apparatus 400. For example, power source 434 may include one or more dry cell batteries, solar cells, fuel cells, etc.

[0087] Processor 440 may also be coupled to a GPS chipset 436, which may be configured to provide location information (e.g., longitude and latitude) regarding the current location of device 400. In addition to, or instead of, information from GPS chipset 436, device 400 may receive location information over the air interface from a base station, e.g., a WiFi base station, and / or determine its location based on the timing of signals being received from two or more nearby base stations.

[0088] The processor 440 may further be coupled to other peripherals 438, which may include one or more software and / or hardware modules that provide additional features, functionality, and / or wired or wireless connectivity. For example, the peripherals 438 may include various sensors such as an accelerometer, a biometric (e.g., fingerprint) sensor, an e-compass, a satellite transceiver, a digital camera (for photos or videos), a universal serial bus (USB) port or other interconnect interface, a vibration device, a television transceiver, a hands-free headset, a Bluetooth module, a frequency modulated (FM) radio unit, a digital music player, a media player, a video game player module, an internet browser, etc.

[0089] Apparatus 400 may be included in other apparatuses or devices, such as a sensor, a consumer electronics device, a wearable device such as a smart watch or smart clothing, a medical or e-health device, a robot, industrial equipment, a drone, or a vehicle such as a car, truck, train, or airplane. Apparatus 400 may connect to other components, modules, or systems of such apparatuses or devices via one or more interconnection interfaces, such as an interconnection interface that may comprise one of peripherals 438.

[0090] FIG. 5 is a block diagram of an exemplary computing system 90 that may be used as or as part of central system 240 of FIGS. 7 and 8. Computing system 90 may comprise a computer or server and may be controlled primarily by computer-readable instructions, which may be in the form of software, wherever or by whatever means such software may be stored or accessed. Such computer-readable instructions may be executed within processor 91 to operate computing system 90. Processor 91 may be a general-purpose processor, a special-purpose processor, a conventional processor, a digital signal processor (DSP), multiple microprocessors, one or more microprocessors associated with a DSP core, a controller, a microcontroller, an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA) circuit, any other type of integrated circuit (IC), a state machine, etc. Processor 91 may perform signal coding, data processing, power control, input / output processing, and / or any other function that enables computing system 90 to operate in a communications network. Co-processor 81 is an optional processor separate from main processor 91 that may perform additional functions or assist processor 91. Processor 91 and / or co-processor 81 may receive, generate, and process data related to the methods and apparatus disclosed herein.

[0091] In operation, processor 91 fetches, decodes, and executes instructions and transfers information to and from other resources via system bus 80, which is the computing system's primary data transfer path. Such a system bus connects components in computing system 90 and defines a medium for data exchange. System bus 80 typically includes data lines for transmitting data, address lines for transmitting addresses, and control lines for transmitting interrupts and operating the system bus. An example of such a system bus 80 is a PCI (Peripheral Component Interconnect) bus.

[0092] The memories coupled to the system bus 80 include random access memory (RAM) 82 and read-only memory (ROM) 93. Such memories include circuitry that allows information to be stored and retrieved. ROM 93 generally contains stored data that cannot be easily modified. Data stored in RAM 82 can be read or changed by the processor 91 or other hardware devices. Access to RAM 82 and / or ROM 93 may be controlled by a memory controller 92. The memory controller 92 may provide an address translation function that converts virtual addresses to physical addresses when instructions are executed. The memory controller 92 may also be provided with a memory protection function that separates processes within the system and separates system processes from user processes. Thus, a program operating in the first mode may only access memory mapped by its own process virtual address space and cannot access memory in another process's virtual address space unless memory sharing between the processes is set up.

[0093] Additionally, computing system 90 may include a peripheral controller 83 that is responsible for communicating instructions from processor 91 to peripheral devices such as printer 94 , keyboard 84 , mouse 95 , and disk drive 85 .

[0094] The display 86, controlled by the display controller 96, is used to display visual output generated by the computing system 90. Such visual output may include text, graphics, animated graphics, and video. The visual output may be provided in the form of a graphical user interface (GUI). The display 86 may be implemented with a CRT-based video display, an LCD-based flat-panel display, a gas plasma-based flat-panel display, or a touch panel. The display controller 96 includes the electronic components required to generate the video signal sent to the display 86.

[0095] Additionally, computing system 90 may include communications circuitry, such as, for example, a wireless or wired network adapter 97, that may be used to connect computing system 90 to external communications networks or devices, for example, to communicate with other network devices and connect to WiFi, cellular, and other networks via a network connection to connect with communications devices, such as communications device 240 of FIGS. 7 and 8. It should be noted that the present invention includes the following aspects. [Aspect 1] 1. A communication device, comprising: at least one processor; wireless communication circuitry in communication with the at least one processor; a memory in communication with the at least one processor; Computer-executable instructions stored in the memory that, when executed by the at least one processor, cause the communications device to: establishing a wireless communication link with a first clinical supply pack, the first clinical supply pack comprising a controller, an electronic label in communication with the controller, and a clinical supply; providing, via the wireless communication link, labeling information including information about a first patient on the first clinical supply pack while the first clinical supply pack is sealed for distribution, the labeling information including information about a first patient, the patient's name, a dosing regimen, and safety information, the dosing regimen and the safety information being provided in a first language in accordance with regulatory requirements for the region in which the first patient will be treated; providing, via the wireless communication link, a set of labeling rules, including an expiration date, to the first clinical supply pack while the first clinical supply pack is sealed for distribution; and A communication device comprising: [Aspect 2] 10. The communications device of aspect 1, wherein the instructions further cause the communications device to establish the communications link with the first clinical supply pack via a wireless communications link with a second clinical supply pack. [Aspect 3] 2. The communication device of aspect 1, wherein the instructions further cause the communication device to establish the wireless communication link with the first clinical supply pack and a second wireless communication link with a second clinical supply pack. [Aspect 4] 2. The communication device of claim 1, wherein the instructions further cause the communication device to establish the wireless communication link with the first clinical supply pack via a coupler, the first clinical supply pack being located in a shipping carton that includes the coupler. [Aspect 5] 2. The communication device of claim 1, wherein the instructions further cause the communication device to provide the dosing regimen and the information to the first clinical supply pack via the wireless communication link in a second language different from the first language. [Aspect 6] 10. The communication device of claim 1, wherein the instructions further cause the communication device to provide the dosing regimen and the information to the first clinical supply pack via the wireless communication link in a second language in response to an input device of the clinical supply pack. [Aspect 7] 10. The communication device of claim 1, wherein the instructions further cause the communication device to provide the dosing regimen and the information to the first clinical supply pack via the wireless communication link in a second language in response to input entered into a user interface of the communication device. [Aspect 8] 2. The communication device of claim 1, wherein the instructions further cause the communication device to provide updated labeling status information for the first clinical supply pack via the wireless communication link in response to a message from a central system, the labeling status information relating to a product recall or expiration date. [Aspect 9] 2. The communication device of claim 1, wherein the instructions further cause the communication device to provide an updated dosing regimen to the first clinical supply pack via the wireless communication link in response to a message from a central system. [Aspect 10] 10. The communication device of aspect 1, wherein the instructions further cause the communication device to collect clinical supply usage or environmental information from the first clinical supply pack via the wireless communication link. [Aspect 11] 10. The communication device of claim 1, wherein the instructions further cause the communication device to provide clinical trial information, including an investigator identifier, a subject identifier, and a study protocol identifier, to the first clinical supply pack via the wireless communication link. [Aspect 12] 10. The communication device of aspect 1, wherein the instructions further cause the communication device to report the clinical supply usage or environmental information to a central management system for a clinical trial. [Aspect 13] A first clinical supply pack comprising: clinical product supplies; Electronic labels and a processor in communication with the electronic label; wireless communication circuitry in communication with the processor; a memory in communication with the processor; Computer-executable instructions stored in the memory that, when executed by the processor, cause the first clinical supply pack to: establishing a wireless communication link with a communication device; receiving, while the first clinical supply pack is sealed for distribution, labeling information from the communication device via the wireless communication link, the labeling information including information about a first patient, a dosing regimen, and safety information, the dosing regimen and the safety information being provided in a first language in accordance with regulatory requirements for the region in which the first patient will be treated; displaying said labeling information on said electronic label; receiving, from the communication device via the wireless communication link, a set of labeling rules including an expiration date for the supply of clinical product while the first clinical supply pack is sealed for distribution, and further receiving a serialization of the first clinical supply pack; adjusting the labeling information according to the labeling rules; receiving labeling status information from the communication device via the wireless communication link, the labeling status information including product status; and adjusting the labeling information according to the product status. [Aspect 14] 14. The first clinical supply pack of claim 13, wherein the instructions further cause the first clinical supply pack to establish the communications link with a communications device via a wireless communications link with a second clinical supply pack. [Aspect 15] 14. The first clinical supply pack of claim 13, wherein the instructions further cause the first clinical supply pack to receive the dosing regimen and the safety information in a second language from the communication device via the wireless communication link. [Aspect 16] 14. The first clinical supply pack of claim 13, wherein the instructions further cause the first clinical supply pack to receive the dosing regimen and the safety information in a second language from the communication device via the wireless communication link in response to an input device of the clinical supply pack. [Aspect 17] 14. The first clinical supply pack of aspect 13, wherein the instructions further cause the first clinical supply pack to display an expiration notice based on evaluation of labeling rules. [Aspect 18] 14. The first clinical supply pack of claim 13, wherein the instructions further cause the first clinical supply pack to receive and display updated labeling status information received by the communication device from a central system via the wireless communication link from the communication device, the labeling status information relating to a product recall or expiration date. [Aspect 19] 14. The first clinical supply pack of claim 13, wherein the instructions further cause the first clinical supply pack to display an updated dosing regimen received from a central system over the wireless communication link via the communication device. [Aspect 20] 14. The first clinical supply pack of claim 13, wherein the instructions further cause the first clinical supply pack to provide clinical supply usage or environmental information to a central system via the wireless communication link to the communication device. [Aspect 21] 14. The first clinical supply pack of aspect 13, wherein the instructions further cause the first clinical supply pack to receive and display clinical trial information from the communication device via the wireless communication link, the clinical trial information including an investigator identifier, a subject identifier, and a study protocol identifier. [Aspect 22] 14. The first clinical supply pack of claim 13, wherein the instructions further cause the first clinical supply pack to report the clinical supply usage or environmental information to a central clinical trial management system via the communication device. [Aspect 23] 1. A method comprising: establishing a wireless communication link with a first clinical supply pack, the first clinical supply pack comprising a controller, an electronic label in communication with the controller, and a clinical supply; providing, via a secure wireless communication link, labeling information including information about a first patient on the first clinical supply pack while the first clinical supply pack is sealed for distribution, the labeling information including information about the first patient, including the patient's name, a dosing regimen, and safety information, the dosing regimen and the safety information being provided in a first language in accordance with regulatory requirements for the region in which the first patient will be treated; providing a set of labeling rules, including an expiration date, to the first clinical supply pack via the secure wireless communication link while the first clinical supply pack is sealed for distribution. [Aspect 24] 24. The method of embodiment 23, further comprising establishing the secure communications link with the first clinical supply pack via a second wireless communications link with a second clinical supply pack. [Aspect 25] 24. The method of embodiment 23, further comprising providing the dosing regimen and the labeling information on the first clinical supply pack via the secure wireless communication link in a second language different from the first language. [Aspect 26] 24. The method of claim 23, further comprising providing the dosing regimen and the information in a second language to the first clinical supply pack via the secure wireless communication link in response to an input device on the clinical supply pack. [Aspect 27] 24. The method of claim 23, further comprising providing the dosing regimen and the information in a second language to the first clinical supply pack via the secure wireless communication link in response to inputs entered into a user interface of the communication device. [Aspect 28] 24. The method of claim 23, further comprising providing updated labeling status information to the first clinical supply pack via the secure wireless communication link in response to a message from a central system, the labeling status information being related to a product recall or expiration date. [Aspect 29] 24. The method of embodiment 23, further comprising providing an updated dosing regimen to the first clinical supply pack via the secure wireless communication link in response to a message from a central system. [Aspect 30] 24. The method of aspect 23, further comprising collecting clinical supply usage or environmental information from the first clinical supply pack via the secure wireless communication link. [Aspect 31] 24. The method of aspect 23, further comprising providing clinical trial information to the first clinical supply pack via the secure wireless communication link, the clinical trial information including an investigator identifier, a subject identifier, and a study protocol identifier. [Aspect 32] 32. The method of embodiment 31, further comprising reporting said clinical supply usage or environmental information to a central management system for a clinical trial. [Aspect 33] 1. A method comprising: establishing a wireless communication link with a communication device in a clinical supply pack, the clinical supply pack comprising a processor, a supply of clinical products, and an electronic label; receiving, while the first clinical supply pack is sealed for distribution, labeling information from the communication device via the wireless communication link, the labeling information including information about a first patient, a dosing regimen, and safety information, the dosing regimen and the safety information being provided in a first language in accordance with regulatory requirements for the region in which the first patient will be treated; displaying said labeling information on an electronic label; receiving, from the communication device via the wireless communication link, a set of labeling rules including an expiration date for the supply of clinical product while the first clinical supply pack is sealed for distribution, and further receiving a serialization of the first clinical supply pack; adjusting the labeling information according to the labeling rules; receiving labeling status information from the communication device via the wireless communication link, the labeling status information including product status; and adjusting the labeling information according to the product condition. [Aspect 34] 34. The method of claim 33, wherein the instructions further cause the first clinical supply pack to receive the dosing regimen and the safety information in a second language from the communication device via the wireless communication link in response to an input device of the clinical supply pack. [Aspect 35] 34. The method of claim 33, wherein the instructions further cause the first clinical supply pack to receive and display updated labeling status information received by the communication device from a central system via the wireless communication link from the communication device, the labeling status information relating to a product recall or expiration date. [Aspect 36] 34. The method of claim 33, wherein the instructions further cause the first clinical supply pack to receive and display, via the wireless communication link, an updated dosing regimen from the first clinical supply pack received by the communication device from a central system. [Aspect 37] 34. The method of aspect 33, wherein the instructions further cause the first clinical supply pack to provide clinical supply usage or environmental information to a central system via the wireless communication link to the communication device. [Aspect 38] 34. The method of aspect 33, wherein the instructions further cause the first clinical supply pack to receive and display clinical trial information from the communication device via the wireless communication link, the clinical trial information including an investigator identifier, a subject identifier, and a study protocol identifier. [Aspect 39] 34. The method of aspect 33, wherein the instructions further cause the first clinical supply pack to report the clinical supply usage or environmental information to a central clinical trial management system via the communication device. [Aspect 40] 1. A method comprising: providing labeling information for a plurality of clinical supply packs by transmitting, from a central computing system, unique labeling information for each clinical supply pack to a plurality of communication devices, each clinical supply pack comprising a clinical supply, a processor, and an electronic label; and receiving a confirmation for each clinical supply bag from one or more of the plurality of communication devices that the one or more of the plurality of communication devices successfully received the unique labeling information. [Aspect 41] 41. The method of aspect 40, further comprising receiving, via one of the communication devices, from the clinical supply pack, a report of usage information regarding clinical supply dosage units of the clinical supply pack. [Aspect 42] The method of aspect 40, further comprising receiving, via one of the communication devices, a request for additional labeling information from a clinical supply pack, the request relating to a user selection indicated by actuation of a user input on the clinical supply pack in the context of displayed information. [Aspect 43] 41. The method of embodiment 40, further comprising receiving a report of environmental information from a clinical supply pack via one of the communication devices. [Aspect 44] 44. The method of embodiment 43, further comprising transmitting, via the one of the communication devices, updated information to the clinical supply pack, the updated information including an indication of expiration of the clinical supply.

Claims

1. A first clinical supply pack comprising: clinical product supplies; Electronic labels and a processor in communication with the electronic label; wireless communication circuitry in communication with the processor; a memory in communication with the processor; Computer-executable instructions stored in the memory that, when executed by the processor, cause the first clinical supply pack to: establishing a wireless communication link with a communication device; receiving, while the first clinical supply pack is sealed for distribution, from the communication device via the wireless communication link, labeling information including information about a first patient, a dosing regimen, and safety information, the dosing regimen and the safety information being provided in a first language in accordance with regulatory requirements for the region in which the first patient will be treated; displaying said labeling information on said electronic label; receiving a set of labeling rules from the communication device via the wireless communication link while the first clinical supply pack is sealed for distribution, the labeling rules including an expiration date for the supply of clinical product, and further receiving a serialization of the first clinical supply pack; adjusting the labeling information according to the labeling rules; receiving labeling status information from the communication device via the wireless communication link, the labeling status information including product status; adjusting the labeling information according to the product condition; the computer-executable instructions causing 10. The first clinical supply pack comprising:

2. 10. The first clinical supply pack of claim 1, wherein the instructions further cause the first clinical supply pack to establish the communications link with a communications device via a wireless communications link with a second clinical supply pack.

3. 10. The first clinical supply pack of claim 1, wherein the instructions further cause the first clinical supply pack to receive the dosing regimen and the safety information in a second language from the communication device via the wireless communication link.

4. 10. The first clinical supply pack of claim 1, wherein the instructions further cause the first clinical supply pack to display an expiration notice based on evaluation of labeling rules.

5. 10. The first clinical supply pack of claim 1, wherein the instructions further cause the first clinical supply pack to receive and display, via the wireless communication link from the communication device, updated labeling status information received by the communication device from a central system, the labeling status information relating to a product recall or expiration date.

6. 10. The first clinical supply pack of claim 1, wherein the instructions further cause the first clinical supply pack to display an updated dosing regimen received from a central system via the communication device over the wireless communication link.

7. 10. The first clinical supply pack of claim 1, wherein the instructions further cause the first clinical supply pack to provide usage or environmental information of the first clinical supply pack to a central system via the wireless communication link to the communication device.

8. 10. The first clinical supply pack of claim 1, wherein the instructions further cause the first clinical supply pack to receive and display clinical trial information from the communication device via the wireless communication link, the clinical trial information including an investigator identifier, a subject identifier, and a study protocol identifier.

9. 1. A method comprising: establishing a wireless communication link with a communication device in a first clinical supply pack comprising a processor, a supply of clinical product, and an electronic label; receiving, by the first clinical supply pack while the first clinical supply pack is sealed for distribution, from the communication device via the wireless communication link, labeling information including information about a first patient, a dosing regimen, and safety information, the dosing regimen and the safety information being provided in a first language in accordance with regulatory requirements for the region in which the first patient will be treated; the first clinical supply pack displaying the labeling information on an electronic label; receiving a set of labeling rules, including an expiration date for the supply of clinical product, from the communication device via the wireless communication link while the first clinical supply pack is sealed for distribution, and further receiving a serialization of the first clinical supply pack; adjusting the labeling information of the first clinical supply pack according to the labeling rules; receiving, by the first clinical supply pack, labeling status information from the communication device via the wireless communication link, the labeling status information including product status; adjusting the labeling information of the first clinical supply pack according to the product status; The method comprising:

10. 10. The method of claim 9, further comprising the first clinical supply pack receiving the dosing regimen and the safety information from the communication device via the wireless communication link.

11. 10. The method of claim 9, further comprising the first clinical supply pack receiving and displaying, via the wireless communication link from the communication device, updated labeling status information received by the communication device from a central system, the labeling status information relating to a product recall or expiration date.

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