CLINICAL TRIAL SITE INTEGRATION TO EDC
STREAMLINING CLINICAL TRIAL OPERATIONS
FOR DATA SHARED BETWEEN CLINICAL TRIAL SITES AND AN EDC, ENTITECH SOLUTIONS IMPROVED THE LATENCY FROM 2 WEEKS TO NEAR REAL-TIME.
The process of collecting data from clinical sites during the clinical trial process is cumbersome and error prone. It requires site personnel to cut and paste information from their electronic medical record system (EMR) to the sponsor’s electronic data capture system (EDC).
Due to the time intensive nature of the process and the workload of site staff, there can be weeks between the subject visit and the data entry.
Entitech Solutions has worked with a “Top Five” pharmaceutical company to develop a direct integration between clinical sites and the EDC system. Where other efforts have had mixed success attempting to integrate directly into the site’s EMR system, our solution: provides an extremely flexible integration architecture which can leverage any existing data warehouse or business-to-business (B2B) integration capability. By supporting various integration methods, sites can onboard quickly and leverage their existing integration solutions for removing protected health information (PHI) thereby removing need for HIPAA compliance on the sponsor side.
- Provides extremely flexible integration architecture which can leverage any existing data warehouse or business-to-business (B2B) integration capability.
- Quick onboarding for sites and leverages their existing integration solutions for removing PHI
- Removes the need for HIPPA compliance on the sponsor side because of the integrated solutions that remove PHI also.
As of now, six (6) sites have been onboarded to the platform and have tested submitting data in real-world scenarios. Data latency was measured to improve from an average of two weeks between visit and data receipt to a worst-case scenario of a 24-hour latency. In some cases, the sites are sending data in near real-time. Due to the flexible nature of the solution, our ability to onboard sites requires minimal discussion with IT staff and in some cases requires little to no effort.