Clinical Precedent in two minutes
The walkthrough in brief: what the FDA inspection record shows on a clinical investigator or site before a sponsor signs, and how Clinical Precedent puts it in front of you.
Transcript
Clinical Precedent. Clinical investigator vetting on the FDA record. Choosing a qualified clinical investigator is the sponsor's obligation under 21 CFR 312.53.
Qualification is usually read as credentials: CV, licensure, trial experience, site capabilities, and the sponsor's own history with the clinical investigator. But a clinical investigator's regulatory history is part of the same question.
That history is public, but it is scattered across systems that do not talk to each other, and it is not easy to find. Clinical Precedent curates FDA's Bioresearch Monitoring data for drugs and biologics, no matter where in the world the inspection took place, into one vetting tool: inspections, findings and warning letters, every source checked daily. Enter a name or FEI number and see every inspection, its classification, the findings cited and any warning letters, benchmarked against the whole data set. Compare finalists side by side, and check the disqualification and debarment lists. Search thousands of findings by concept, by problem area or by regulation, and drill down to the source record every time. See what FDA is citing right now, and prepare for your own inspection with a readiness checklist built from the findings FDA cited. Keep the clinical investigators, CROs and IRBs you work with on a watchlist, and get a weekly digest of any new FDA activity.
Thank you. Visit clinicalprecedent.com.