INTEGRATED CLINICAL TRIAL WORKFLOW SYSTEM

• US 20110313782A1
• Filed: 11/02/2010
• Published: 12/22/2011
• Est. Priority Date: 06/16/2010
• Status: Active Grant

• Current Assignee: Calyx Services Incorporated
• Original Assignee: Parexel International Corporation
• Inventors: DeMeyer, Christopher C., Byrom, William, Dowlman, Iain A., Kochanski, Dennis A., Davis, April D.
• Granted Patent: US 10,074,147 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A computer-based system configured to present a user interface that enables a user to access multiple clinical trial systems via a common secure web-based interface. Data integration and reconciliation achieved using an integration platform, in which multiple clinical trial systems are connected to a central messaging hub, provides an integrated clinical trial workflow system that reduces the redundancy in data entry and functionality present in conventional clinical trial workflow systems that employ standalone systems for various aspects of clinical trial management. Aggregation of data using the integration platform provides clinical trial directors with consolidated useful information for making management decisions and the user interface may be dynamically configured based, at least in part, on user access credentials resulting in a more efficient workflow for administrators of a clinical trial.

Claims

1. At least one non-transitory computer-readable storage medium encoded with a plurality of computer-executable instructions that, when executed by at least one processor, perform a method comprising:

displaying a user interface configured to provide a user access to a plurality of clinical trial functions via the at least one user interface, wherein the plurality of clinical trial functions includes at least two of data collection, patient randomization, medication dispensation, clinical trial management, medical image processing, patient self-reported data collection, clinical endpoint adjudication, and serious adverse event reporting and processing.

2. The non-transitory computer-readable storage medium of claim 1, wherein the method further comprises:

prompting the user for identifying information;

receiving the identifying information from the user; and

configuring the user interface based, at least in part, on the identifying information.

3. The non-transitory computer-readable storage medium of claim 2, wherein configuring the user interface comprises:

accessing an identity management system to determine access rights for the user based on the identifying information; and

displaying, on the user interface, only the clinical trial functions to which the user is authorized to access based on the access rights.

4. The non-transitory computer-readable storage medium of claim 1, wherein the method further comprises:

displaying, on the user interface, identifiers for a plurality of clinical trials; and

prompting the user to select one of the identifiers for the plurality of clinical trials.

5. The non-transitory computer-readable storage medium of claim 1, wherein the method further comprises:

displaying a first display area, wherein the first display area includes links to a plurality of clinical trial systems; and

providing access to each of the plurality of clinical systems without prompting the user for identifying information.

6. The non-transitory computer-readable storage medium of claim 5, wherein at least one of the plurality of clinical trial systems is a clinical trial management application.

7. The non-transitory computer-readable storage medium of claim 5, wherein at least one of the plurality of clinical trial systems is an electronic data collection application.

8. The non-transitory computer-readable storage medium of claim 5, wherein the method further comprises:

executing a first system of the plurality of clinical trial system in response to a selection of one of the links in the first display area.

9. The non-transitory computer-readable storage medium of claim 8, wherein the method further comprises:

receiving data from a second system of the plurality of clinical trial systems in response to an interaction by the user with the first system; and

displaying the data from the second system on a portion of the at least one user interface.

10. The non-transitory computer-readable storage medium of claim 8, wherein the method further comprises:

receiving, via an integration platform, data from the first system in response to the user entering the data in the first system;

determining that the data should be provided to at least one other system of the plurality of clinical trial systems; and

sending automatically, the data from the first system to the at least other system in response to determining that the data should be provided to the at least one other system.

11. The non-transitory computer-readable storage medium of claim 8, wherein the method further comprises:

sending a command from the first system to an integration platform in response to an action performed by the user in the first system;

determining, by the integration platform, that the command should be sent to a second system of the plurality of clinical trial applications;

and sending the command to the second system in response to determining that the command should be sent to the second system;

wherein the command changes data associated with the second system.

12. The non-transitory computer-readable storage medium of claim 1, wherein the plurality of clinical trial functions are associated with a plurality of clinical trial systems, and wherein the method further comprises:

exposing a first clinical trial function of the plurality of clinical trial functions within at least two of the plurality of clinical trial systems to enable the user to access the first clinical trial function from within the at least two clinical trial systems.

13. The non-transitory computer-readable storage medium of claim 12, wherein the at least two clinical trial systems includes an EDC system and an RTSM system and wherein exposing the first clinical trial function comprises:

receiving, via the EDC system, an input indicating that a patient identified based on patient data in the EDC system is to be randomized;

transmitting a request for randomization information to the RTSM system; and

receiving, from the RTSM system, the randomization information for the patient.

14. The non-transitory computer-readable storage medium of claim 12, wherein the at least two clinical trial systems includes a CTMS and an RTSM system, and wherein exposing the first clinical trial function comprises:

transmitting, from the CTMS, a request for medication supply information to the RTSM system;

receiving the medication supply information from the RTSM system;

integrating the medication supply information with site information stored in the CTMS; and

displaying integrated information on the at least one user interface.

15. The non-transitory computer-readable storage medium of claim 12, wherein the at least two clinical trial systems includes a CTMS and an RTSM system, and wherein exposing the first clinical trial function comprises:

determining, by the CTMS, that a site is ready for activation; and

transmitting, to the RTMS, a request to send a first supply of medication to the site in response to determining that the site is ready for activation.

16. The non-transitory computer-readable storage medium of claim 1, wherein the method further comprises:

displaying, on the at least one user interface, a document repository including at least one document related to a clinical trial.

17. The non-transitory computer-readable storage medium of claim 16, wherein the at least one document includes a clinical trial protocol and/or at least one amendment to the clinical trial protocol.

18. A method of operating a computer for managing at least one aspect of a clinical trial, the method comprising:

operating at least one processor to;

display at least one user interface configured to provide a user access to a plurality of clinical trial functions via the at least one user interface, wherein the plurality of clinical trial functions includes at least two of data collection, patient randomization, medication dispensation, clinical trial management, medical image processing, patient self-reported data collection, clinical endpoint adjudication, and serious adverse event reporting and processing.

19. The method of claim 18, further comprising:

prompting the user for identifying information;

receiving the identifying information from the user; and

configuring the user interface based, at least in part, on the identifying information.

20. The method of claim 19 wherein configuring the user interface comprises:

accessing an identity management system to determine access rights for the user based on the identifying information; and

displaying, on the user interface, only the clinical trial functions to which the user is authorized to access based on the access rights.

21. The method of claim 18, further comprising:

displaying a first display area, wherein the first display area includes links to a plurality of clinical trial systems; and

providing access to each of the plurality of clinical systems without prompting the user for identifying information.

22. The method of claim 21, further comprising:

executing a first system of the plurality of clinical trial systems in response to a selection of one of the links in the first display area.

23. The method of claim 22, further comprising:

receiving data from a second system of the plurality of clinical trial systems in response to an interaction by the user with the first system; and

displaying the data from the second system on a portion of the at least one user interface.

24. The method of claim 22, further comprising:

receiving, via an integration platform, data from the first system in response to the user entering the data in the first system;

determining that the data should be provided to at least one other system of the plurality of clinical trial systems; and

sending automatically, the data from the first system to the at least other system in response to determining that the data should be provided to the at least one other system.

25. The method of claim 22, further comprising:

sending a command from the first system to an integration platform in response to an action performed by the user in the first system;

determining, by the integration platform, that the command should be sent to a second system of the plurality of clinical trial applications;

and sending the command to the second system in response to determining that the command should be sent to the second system;

wherein the command changes data associated with the second system.

26. The method of claim 18, wherein the plurality of clinical trial functions are associated with a plurality of clinical trial systems, and wherein the method further comprises:

exposing a first clinical trial function of the plurality of clinical trial functions within at least two of the plurality of clinical trial systems to enable the user to access the first clinical trial function from within the at least two clinical trial systems.

27. The method of claim 26, wherein the at least two clinical trial systems includes an EDC system and an RTSM system and wherein exposing the first clinical trial function comprises:

receiving, via the EDC system, an input indicating that a patient identified based on patient data in the EDC system is to be randomized;

transmitting a request for randomization information to the RTSM system; and

receiving, from the RTSM system, the randomization information for the patient.

28. The method of claim 26, wherein the at least two clinical trial systems includes a CTMS and an RTSM system, and wherein exposing the first clinical trial function comprises:

transmitting, from the CTMS, a request for medication supply information to the RTSM system;

receiving the medication supply information from the RTSM system;

integrating the medication supply information with site information stored in the CTMS; and

displaying integrated information on the at least one user interface.

29. The method of claim 26, wherein the at least two clinical trial systems includes a CTMS and an RTSM system, and wherein exposing the first clinical trial function comprises:

determining, by the CTMS, that a site is ready for activation; and

transmitting, to the RTMS, a request to send a first supply of medication to the site in response to determining that the site is ready for activation.

30. A computer system comprising:

at least one processor;

an output device; and

a computer-readable storage medium encoded with computer-executable instructions that when executed, perform a method comprising;

connecting a plurality of clinical trial systems using an integration platform; and

display, on the output device, at least one user interface configured to provide a user access to the plurality of clinical trial systems via a portal, wherein the portal is configured to interact with the integration platform to provide the user interface with integrated functionality, wherein the integrated functionality includes integrating at least two of data collection, patient randomization, medication dispensation, clinical trial management, medical image processing, patient self-reported data collection, clinical endpoint adjudication, and serious adverse event reporting and processing.