Data Management provides all of the database services for the DCRI in support of clinical research.
With a 40-year record of managing large clinical databases, the roots of the DCRI's data management expertise grew out of the Duke University Medical Center’s renowned Duke Databank begun in 1968. This long history distinguishes the DCRI as having the expertise to work with multiple clinical data management systems, involving complex integrations, on a full range of studies in all phases and therapeutic areas.
- Screen Design
- Database design
- Database programming
- 21 CFR part 11 compliant validation process
- Electronic Data Capture (EDC) Support Services
- Loading, reconciliation and integration of external data
- Medical coding
- Status reporting
Electronic Data Capture (EDC)
With a rich history supporting paper-based studies, representing over 3.5 million pages processed, the DCRI began offering Electronic Data Capture (EDC) in 1999. Today, we offer EDC web-based services provided by the InForm platform.
The DCRI provides all the expected advantages of EDC, including electronic entry and query management, near real-time study status metrics, on-line review, and shorter database lock times. In addition, we have enhanced the value EDC brings to the study team with reporting, true integration with IVRS, labs, and safety systems, and direct-from-patient data capture. The DCRI also captures electronic source (eSource) data for many trials, including data from eECGs, continuous hemodynamic monitors, DEXA, pacemaker interrogations, and other therapeutic and diagnostic devices.
DCRI has conducted over 80 EDC studies with patient populations ranging from less than 50 to more than 10,000. We are unique in our ability to run large, global studies in EDC.
The DCRI was a founding sponsor of the Clinical Data Interchange Standards Consortium (CDISC), maintains sponsorship, sits on the Industry Advisory Board, and has employees on CDISC model teams. The DCRI also is a partner in the SingleSource project with CDISC.
Among the DCRI's data managers are 16 Certified Clinical Data Managers, several of whom also helped develop the certification exam offered by the Society for Clinical Data Management.
Data Integration and Reporting
We deliver data in client-specific structures and formats. Our trials often involve external data from IVRS, central and core labs, eSource, event committees, and patient reports. For real-time trial-management reports, site payments, and interim analyses, we continuously integrate these data with clinical databases. We also routinely reconcile data against safety-surveillance systems held at the DCRI, with the client, or with a third party.
Contact Walter Kwiatek, Executive Director, Data and Technology Solutions, for more information about these services.