SAFETY DATA, SURVEILLANCE, & IMPLEMENTING STUDIES

Our professionals’ analyses of benefits and risks throughout the investigational, clinical trial, launch, and marketing stages of medical products’ lives have been requested often for FDA submissions.  Our scientists have a broad as well as detailed understanding and experience in conducting literature searches and reviews focused on both efficacy and safety issues.  We are adept at the research, collection, and evaluation of postmarketing adverse events and the preparation of updated product labeling for the safe use of drug, device, biologics, dietary supplement, and food products. We use pharmacovigilance and postmarketing surveillance procedures intended to assess reporting trends, including research across a variety of databases (e.g. FAERS, MAUDE, CAERS, administrative claims databases) to help detect new safety concerns, and track the evolution of previously identified concerns and develop potential mitigation strategies.

No project is too small or too large.  Please reach out to us with any of your needs or questions.