Integrated clinical trial workflow system

• US 10,074,147 B2
• Filed: 11/02/2010
• Issued: 09/11/2018
• 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.
• Primary Examiner(s): Chng, Joy Poh Ai
• Application Number:
  US12/938,276
• Publication Number:
  US 20110313782A1
• Time in Patent Office: 2,870 Days
• Field of Search: 705 2- 3
• 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. A computer system comprising:

at least one server implementing a plurality of clinical trial systems;

an input/output device; and

at least one processor in communication with 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;

receiving identifying information from a user;

integrating functionality from the plurality of clinical trial systems by dynamically configuring so as to customize an integrated user interface that provides the user access to functionality from each of the plurality of clinical trial systems,

wherein dynamically configuring the integrated user interface comprises dynamically configuring the integrated user interface based, at least in part, on the identifying information,

wherein dynamically configuring the integrated user interface comprises selecting, for inclusion in the integrated user interface, a first clinical trial function of a first clinical trial system of the plurality of clinical trial systems and a second clinical trial function of a second clinical trial system of the plurality of clinical trial systems,

wherein each of the plurality of clinical trial systems includes a functional module configured to provide a clinical trial function for the clinical trial system, the first clinical trial function being provided by a first functional module of the first clinical trial system and the second clinical trial function being provided by a second functional module of the second clinical trial system,

wherein the plurality of clinical trial systems include at least two systems from a group of clinical trial systems consisting of an RTSM system, an EDC system, and a CTMS, and

wherein the clinical trial function provided by the functional module of each of the plurality of clinical trial systems is a clinical trial function from the group of clinical trial functions consisting 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; and

presenting via the input/output device the dynamically-configured, integrated user interface, wherein the integrated user interface is configured to, based on user interaction with the interface, initiate automatic access to the first clinical trial function and the second clinical trial function without the user having to separately access the first clinical trial system and the second clinical trial system, respectively.

2. The computer system of claim 1, wherein:

the identifying information from the user is based, at least in part, on whether the user has completed certain training or a certification process.

3. The computer system of claim 1, wherein dynamically configuring the integrated user interface comprises:

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

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

4. The computer system of claim 1, wherein the method further comprises:

displaying, on the integrated 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 computer system of claim 1, wherein the method further comprises:

displaying a first display area, wherein the first display area includes links to the 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 computer system of claim 5, wherein at least one of the plurality of clinical trial systems is a clinical trial management application.

7. The computer system of claim 6, wherein:

at least one of the plurality of clinical trial systems is an electronic data collection application; and

dynamically configuring the user interface comprises selectively presenting functions of the clinical trial management application at a first time and functions of the electronic data collection application at a second time.

8. The computer system of claim 5, wherein the method further comprises:

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.

9. The computer system 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 integrated user interface.

10. The computer system 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 one other system in response to determining that the data should be provided to the at least one other system.

11. The computer system 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 computer system of claim 1, wherein the at least two clinical trial systems includes an EDC system and an RTSM system and wherein integrating functionality from the plurality of clinical trial systems further 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.

13. The computer system of claim 1, wherein the at least two clinical trial systems includes a CTMS and an RTSM system, and wherein integrating functionality from the plurality of clinical trial systems further 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 integrated user interface.

14. The computer system of claim 1, wherein the at least two clinical trial systems includes a CTMS and an RTSM system, and wherein integrating functionality from the plurality of clinical trial systems further comprises:

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

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

15. The computer system of claim 1, wherein the method further comprises:

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

16. The computer system of claim 15, wherein the at least one document includes a clinical trial protocol and/or at least one amendment to the clinical trial protocol.

17. The computer system of claim 1, wherein dynamically configuring the integrated user interface comprises dynamically configuring the integrated user interface to provide a user concurrent access to functionality from each of the plurality of clinical trial systems.

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

operating at least one processor to;

receive role and profile information about a user;

integrate functionality from a plurality of functional modules by dynamically configuring an integrated user interface that provides a user access to functionality from each of the plurality of functional modules,

wherein dynamically configuring the integrated user interface comprises dynamically configuring the integrated user interface based, at least in part, on the role and profile information,

wherein dynamically configuring the integrated user interface comprises accessing configuration information for an identity management system to determine access rights for the user based on the configuration information, role and profile information and selecting, for inclusion in the integrated user interface and based at least in part on clinical trial functions that the access rights indicate the user is authorized to access, a first clinical trial function and a second clinical trial function,

wherein the first clinical trial function is provided by a first functional module and the second clinical trial function is provided by a second functional module,

wherein the plurality of functional modules include at least one functional module from a group of functional modules consisting of a randomization engine, a data store, a data transformation engine, an audit trail module, an event processor, a security management module, and a query resolution system,

wherein the clinical trial function provided by each of the plurality of functional modules is a clinical trial function from the group of clinical trial functions consisting 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; and

display the dynamically-configured, integrated user interface, and based on user interaction with the integrated user interface initiating automatic access to the first clinical trial function and the second clinical trial function.

19. The method of claim 18, wherein:

each of the plurality of functional modules is part of a system of a plurality of clinical trial systems, and

the plurality of clinical trial systems include at least two systems from a group of clinical trial systems consisting of an RTSM system, an EDC system, and CTMS;

the method further comprising;

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

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

20. The method of claim 19, 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.

21. The method of claim 20, 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 integrated user interface.

22. The method of claim 20, 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.

23. The method of claim 20, 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.

24. The method of claim 18, wherein each of the plurality of functional modules is part of a clinical trial system of a plurality of clinical trial systems, wherein the plurality of clinical trial systems include at least two systems from a group of clinical trial systems consisting of an RTSM system, an EDC system, and CTMS, wherein the at least two clinical trial systems includes an EDC system and an RTSM system and wherein integrating functionality from the plurality of clinical trial systems further 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.

25. The method of claim 18, wherein each of the plurality of functional modules is part of a system of a plurality of clinical trial systems, wherein the plurality of clinical trial systems include at least two systems from a group of clinical trial systems consisting of an RTSM system, an EDC system, and CTMS, wherein the at least two clinical trial systems includes a CTMS and an RTSM system, and wherein integrating functionality from the plurality of clinical trial systems further 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 integrated user interface.

26. The method of claim 18, wherein each of the plurality of functional modules is part of a system of a plurality of clinical trial systems, wherein the plurality of clinical trial systems include at least two systems from a group of clinical trial systems consisting of an RTSM system, an EDC system, and CTMS, wherein the at least two clinical trial systems includes a CTMS and an RTSM system, and wherein integrating functionality from the plurality of clinical trial systems further comprises:

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

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

27. The method of claim 18, wherein dynamically configuring the integrated user interface comprises dynamically configuring the integrated user interface to provide a user concurrent access to functionality from each of the plurality of functional modules.

28. The method of claim 18, wherein:

dynamically configuring the user interface further comprises selectively presenting on the user interface, based on the role and profile information of the user, summary graphs or charts that illustrate clinical trial progress data entry interface elements.

29. The method of claim 18, wherein the role and profile information of the user is based, at least in part, on whether the user has completed certain training or a certification process.

30. The method of claim 18, wherein:

each of the plurality of functional modules is part of a clinical trial system of a plurality of clinical trial systems,

the first clinical trial function is provided by the first functional module of a first clinical trial system of the plurality of clinical trial systems,

the second clinical trial function is provided by the second functional module of a second clinical trial system of the plurality of clinical trial systems, and

the dynamically-configured, integrated user interface is configured to provide the user access to the first clinical trial function and the second clinical trial function without the user having to separately access the first clinical trial system and the second clinical trial system, respectively.

31. A computer system comprising:

at least one processor;

an output device coupled via a computer network to at least one server implementing a plurality of functional modules that provide a plurality of clinical trial functions; and

a computer-readable storage medium encoded with computer-executable instructions that when executed by the at least one processor, perform a method comprising;

integrating functionality from the plurality of functional modules by dynamically configuring an integrated user interface that provides a user access to functionality from each of the plurality of functional modules,

wherein dynamically configuring the integrated user interface comprises selecting, for inclusion in the integrated user interface, a first clinical trial function of the plurality of functional modules and a second clinical trial function of the plurality of functional modules,

wherein the first clinical trial function being provided by a first functional module and the second clinical trial function being provided by a second functional module,

wherein the plurality of functional modules include at least one functional module from a group of functional modules consisting of a randomization engine, a data store, a data transformation engine, an audit trail module, an event processor, a security management module, and a query resolution system,

wherein the clinical trial function provided by each of the plurality of functional modules is a clinical trial function from the group of clinical trial functions consisting 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; and

displaying, on the output device, the dynamically-configured, integrated user interface, wherein the integrated user interface is configured to, based on user interaction with the interface, initiate automatic access to the first clinical trial function and the second clinical trial function such that a workflow of the user is improved.

32. The computer system of claim 31, further comprising a diagnostic module configured to diagnose conditions relating to communications among the plurality of functional modules.

33. The computer system of claim 31, wherein

the computer system further comprises an integration platform in electronic communication with the plurality of functional modules;

and

dynamically configuring the user interface comprises receiving from the integration platform information about the clinical trial functions accessible by the user of the computer system such that the user interface is customized for the user.

34. The computer system of claim 33, wherein:

the event processor module is configured to perform actions in response to detecting events.

35. The system of claim 33, wherein:

the integration platform comprises an identity management module configured for the user; and

dynamically configuring the user interface comprises receiving from the identity management module for the user information about the clinical trial functions accessible by the user.

36. The system of claim 35, wherein:

the identity management module is configured to provide information about functions to enable the user to access for each of at least a first clinical trial and a second clinical trial;

dynamically configuring the user interface comprises selectively presenting on the user interface at a first time, functions associated with the first clinical trial, and selectively presenting on the user interface at a second time, functions associated with the second clinical trial; and

the system is configured to selectively present the functions associated with the first clinical trial or the second clinical trial based on user selection of a clinical trial.

37. The system of claim 31, wherein:

dynamically configuring the integrated user interface comprises selecting, for inclusion in the integrated user interface, at least one of the first clinical trial function and the second clinical trial function based on a task being performed by the user accessing the system through the integrated user interface.

38. The system of claim 31, wherein:

the method further comprises;

receiving identifying information from the user,

obtaining from an identity management module the role and profile information, and

dynamically configuring the integrated user interface comprises dynamically configuring the integrated user interface based, at least in part, on the role and profile information of the user.

39. The system of claim 38, wherein the role and profile information of the user is based, at least in part, on whether the user has completed certain training or a certification process.

40. The system of claim 39, wherein each of the plurality of functional modules is part of a clinical trial system of a plurality of clinical trial systems, wherein the plurality of clinical trial systems include at least two systems from a group of clinical trial systems consisting of an RTSM system, an EDC system, and a CTMS.

41. The system of claim 31, wherein:

each of the plurality of functional modules is part of a clinical trial system of a plurality of clinical trial systems,

the first clinical trial function is provided by the first functional module of a first clinical trial system of the plurality of clinical trial systems,

the second clinical trial function is provided by the second functional module of a second clinical trial system of the plurality of clinical trial systems, and

the dynamically-configured, integrated user interface is configured to provide the user access to the first clinical trial function and the second clinical trial function without the user having to separately access the first clinical trial system and the second clinical trial system, respectively.