METHODS AND SYSTEMS FOR SITE STARTUP

• US 20080183498A1
• Filed: 01/31/2008
• Published: 07/31/2008
• Est. Priority Date: 01/31/2007
• Status: Abandoned Application

• Current Assignee: Quintiles Transnational Corporation (IQVIA Holdings, Inc.)
• Original Assignee: Quintiles Transnational Corporation (IQVIA Holdings, Inc.)
• Inventors: Kiss, Sheila Ann, Nichols, Gavin D.T.
• Application Number:
  US12/023,313
• Publication Number:
  US 20080183498A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 10/06311 Scheduling, planning or task assignment for a person or group
• CPC Class Codes: G06Q 10/06316 Sequencing of tasks or work
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

Abstract

Certain embodiments of the present invention provide clinical site information to clinical trial managers to support clinical trial management. One embodiment is a method for providing information in response to an inquiry. A plurality of site attributes is received. The site attributes can include information regarding the sites that may include clinical trial history, identification, or other site information. Each site attribute includes data elements that are associated with clinical trial sites. A site attribute is identified and a score is determined for each data element of the identified site attribute. An inquiry for clinical trial site information is received. The plurality of data elements are searched to identify at least one clinical trial site based on the inquiry. Information associated with the identified at least one clinical trial site is provided.

Claims

1. A method for managing a clinical trial comprising:

receiving a plurality of clinical trial site attributes, each of the plurality of site attributes having a plurality of data elements, each data element being associated with a clinical trial site, wherein the site attributes comprise information regarding at least one of;

number of patients enrolled within a pre-set time period;

transportation hub distance; and

therapeutic area;

identifying at least one site attribute;

determining a score for each data element of the at least one identified site attribute;

receiving an inquiry for clinical trial site information, the inquiry comprising at least one data element value;

searching the plurality of data elements to identify at least one clinical trial site appropriate to consider for the clinical trial based in part on the data element value and the score; and

outputting information associated with the identified at least one clinical trial site.

2. The method of claim 1, wherein determining the score for each data element of the identified at least one site attribute comprises:

determining the score based on a comparison of information of each data element; and

assigning an indicator to each data element based on the score.

3. The method of claim 1, wherein determining the score for each data element of the at least one identified site attribute comprises:

determining the score based on a statistical record; and

assigning an indicator to each data element based on the score.

4. The method of claim 3, wherein the statistical record comprises statistics regarding average information for the identified site attribute.

5. The method of claim 1, further comprising:

authenticating a user; and

providing an inquiry page to the user.

6. The method of claim 1, further comprising:

receiving general information; and

generating a plurality of data elements for a first site attribute using the general information and data elements of a second site attribute.

7. The method of claim 1, wherein the site attributes further comprise information about at least one of:

Clinical Research Associate (CRA) identification;

number of past clinical trials;

accuracy of results;

number of patients screened for enrollment;

partner status;

patient enrollment goal; and

actual patient enrollment.

8. The method of claim 1, wherein the outputted information comprises site identification and at least one of:

CRA identification;

transportation hub distance;

number of past clinical trials;

accuracy of results;

number of patients screened for enrollment;

therapeutic area;

number of patients enrolled within a pre-set time period;

partner status;

patient enrollment goal; and

actual patient enrollment.

12. The system of claim 11, wherein the statistical record comprises statistics regarding average information for the identified site attribute.

9. A system for managing a clinical trial, the system comprising:

a processor-based device adapted to receive a plurality of clinical trial site attributes from a site database, each of the plurality of site attributes having a plurality of data elements, each data element being associated with a clinical trial site, wherein the site attributes comprise information regarding a number of patients enrolled within a pre-set time period;

wherein the processor-based device comprises a site engine adapted to;

identify at least one site attribute;

determine a score for each data element of the at least one identified site attribute;

receive an inquiry for clinical trial site information from an input device, the inquiry comprising at least one data element value;

search the plurality of data elements to identify at least one clinical trial site appropriate to consider for the clinical trial based in part on the data element value and the score; and

output information associated with the identified at least one clinical trial site to an output device.

10. The system of claim 9, wherein the site engine determines the score for each data element of the identified at least one site attribute by:

determining the score based on a comparison of information of each data element; and

assigning an indicator to each data element based on the score.

11. The system of claim 9, wherein the site engine determines the score for each data element of the identified at least one site attribute by:

determining the score based on a statistical record; and

assigning an indicator to each data element based on the score.

13. The system of claim 9, wherein the site engine is adapted to authenticate a user and provide an inquiry page to the output device.

14. The system of claim 9, wherein the site engine is adapted to:

receive general information; and

generate a plurality of data elements for a first site attribute using the general information and data elements of a second site attribute.

15. The system of claim 9, wherein the site attributes further comprise information about at least one of:

Clinical Research Associate (CRA) identification;

number of past clinical trials;

accuracy of results;

number of patients screened for enrollment;

partner status;

patient enrollment goal;

actual patient enrollment;

transportation hub distance; and

therapeutic area.

16. The system of claim 9, wherein the outputted information comprises site identification and at least one of:

CRA identification;

transportation hub distance;

number of past clinical trials;

accuracy of results;

number of patients screened for enrollment;

therapeutic area;

number of patients enrolled within a pre-set time period;

partner status;

patient enrollment goal; and

actual patient enrollment.

17. A computer-readable medium on which is program code for managing a clinical trial, the computer-readable medium comprising:

program code for receiving a plurality of clinical trial site attributes, each of the plurality of site attributes having a plurality of data elements, each data element being associated with a clinical trial site, wherein the site attributes comprise information regarding;

number of patients enrolled within a pre-set time period;

transportation hub distance; and

therapeutic area;

program code for identifying at least one site attribute;

program code for determining a score for each data element of the at least one identified site attribute;

program code for receiving an inquiry for clinical trial site information, the inquiry comprising at least one data element value;

program code for searching the plurality of data elements to identify at least one clinical trial site appropriate to consider for the clinical trial based in part on the data element value and the score; and

program code for outputting information associated with the identified at least one clinical trial site.

18. The computer-readable medium of claim 17, wherein program code for determining the score for each data element of the identified at least one site attribute comprises:

program code for determining the score based on a comparison of information of each data element; and

program code for assigning an indicator to each data element based on the score.

19. The computer-readable medium of claim 17, wherein program code for determining the score for each data element of the at least one identified site attribute comprises:

program code for determining the score based on a statistical record; and

program code for assigning an indicator to each data element based on the score.

20. The computer-readable medium of claim 19, wherein the statistical record comprises statistics regarding average information for the identified site attribute.

21. The computer-readable medium of claim 17, further comprising:

program code for authenticating a user; and

program code for providing an inquiry page to the user.

22. The computer-readable medium of claim 17, further comprising:

program code for receiving general information; and

program code for generating a plurality of data elements for a first site attribute using the general information and data elements of a second site attribute.

23. The computer-readable medium of claim 17, wherein the site attributes further comprise information about at least one of:

Clinical Research Associate (CRA) identification;

number of past clinical trials;

accuracy of results;

number of patients screened for enrollment;

partner status;

patient enrollment goal; and

actual patient enrollment;

24. The computer-readable medium of claim 17, wherein the outputted information comprises site identification and at least one of:

CRA identification;

transportation hub distance;

number of past clinical trials;

accuracy of results;

number of patients screened for enrollment;

number of patients enrolled within a pre-set time period;

therapeutic area;

partner status;

patient enrollment goal; and

actual patient enrollment.