Oncology Case Study
ARG rescues Phase I Oncology Trial Using TrialVista® CTMS
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 The missing pages report was inconsistent, outdated, and included incorrect data.
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 real-time 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.
ARG employs a proprietary, analysis-based surveillance methodology that was developed to identify and minimize potential risks, proactively.
The fundamental concepts behind DDTM are Quality by Design (QbD) and Centralized Data Surveillance (CDS). Through these concepts, DDTM is supporting cross-functional collaboration between functional groups and making proactive adjustments needed for better project success. Through this process, ARG considers and addresses any difficulties in trial design sooner rather than waiting for the final data analysis. QbD focuses on identifying, defining, and collecting critical safety and efficacy endpoints and ensures that the trial design supports those patient safety and data quality for streamlined adoption of CDS.
CDS is an adaptive, targeted approach to clinical trial management. Its purpose is to direct resource allocation and activities in all functional groups, especially the monitor or CRA’s focus to the areas that have the most impact on subject safety and data quality.