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 The missing pages report was inconsistent, outdated, and included incorrect data.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.
Following ARG’s exceptional performance in the Phase I oncology trial, we became the sponsor’s preferred provider for CRO services.