Scope of Work
Devis has a 10 year history of supporting the FDA and the Center for Drug Evaluation and Research (CDER). The Division of Scientific Investigation (DSI) of CDER, and the database systems Devis has developed, stand at the center of the complex challenge of: collecting ever-growing amounts of information and data; orchestrating an inter-disciplinary collaborative analysis; and creating from this a holistic, evidence-based, actionable decision support system for policy makers, regulators, and private sector clinical and non-clinical investigators.
The shared goal of these systems and the participants is to verify the integrity of efficacy and safety for data submitted to the FDA in support of new drug applications and to protect the rights and welfare of human research subjects. In this way, DSI contributes in a direct and material way to enhancing the health of the American people.
Skills and Expertise Required
Devis designs, develops, and deploys the DSI Database Application, built with Microsoft Access, in the FDA CDER environment utilizing the Devis Agile software development methodology. Our Business Analysis professionals work closely with DSI experts to address critical data analysis needs and to track requirements.
Results/Impact
The continuing partnership between Devis and DSI has resulted in high-quality databases for: Complaints Related to FDA-Regulated Clinical Drug Trials; the Prescription Drug User Fee Act (PDUFA); Human Subjects Protection (HSP) Institutional Review Board (IRB); Good Laboratory Practice (GLP); and Bioequivalence (BEQ). The DSI Database application provides a real-time mechanism to collect, analyze and report on large amounts of critical data from these disparate sources.