Integrating EDC And RTSM Solutions

By Natalie Townsend, VP Strategy, Veeva RTSM, Veeva Systems

To accurately randomize and dispense inventory, there are critical data points a randomization and trial supply management (RTSM) solution must capture, for example, data required for stratification or dosing decisions. These same data points also need to be captured in the subject’s casebook via an EDC solution.

Without integration between RTSM and EDC, site users duplicate this data entry, creating additional workload and potential for error. Teams reviewing the data also have duplicated efforts for data review and reconciliation.

Integrating RTSM and EDC is not a new concept by any means; it is common practice. But historically, legacy solutions with legacy integrations have faced challenges such as integration failures, labor-intensive build processes, and difficulties changing data.

Let’s review the benefits and limitations of two different integration approaches: embedding RTSM features directly into the eCRF and connecting stand-alone solutions.