Challenge: A leading specialty pharmaceutical company focused on the development and commercialization of next generation therapies for cancer and immunomodulatory diseases was mired in an unsatisfactory engagement with an offshore CRO for a Phase I oncology trial. Clinical data was delayed weeks in the cleansing and verification stages of the process. The missing pages report was inconsistent, outdated, and included incorrect data.

Results: ARG performed a one-time data dump from the existing CTMS, analyzed the data and worked on-site to prompt corrections to the existing EDC system. The sponsor was extremely pleased with their access to realtime data from TrialVista® CTMS, and with the extremely detail-oriented and successful CRA work that Atlantic Research Group performed to rescue the study and to fix data and procedural problems created by the former CRO.

Lessons Learned: The ability to consistently hit milestones while simultaneously ensuring quality is a differentiating ARG characteristic. Following ARG’s exceptional performance in the Phase I oncology trial, we became the sponsor’s preferred provider for CRO services.