About Clinical Precedent
Clinical Precedent is clinical site intelligence for trial sponsors, CROs and clinical-quality teams: the FDA Bioresearch Monitoring record on a clinical investigator or site — inspection history, the findings cited, warning letters, and disqualification and debarment status — assembled into one check that fits in the site-selection file.
Why it exists
Most sponsors check for an FDA warning letter before engaging a site. It is easy to find, and it is the right first step. But there is a lot more to inspection history than a warning letter. FDA sends inspection findings to the clinical investigator, not typically to the sponsor, and a site running several trials at once may have been inspected on someone else’s study. The classification, the findings and, where it is available, how the site responded are all part of the public record. They are just not in one place, and they are not easy to read.
Clinical Precedent puts that record in one place and makes it readable. Everything in it is built from publicly available FDA data, assembled and cross-referenced so it reads as one record. It reports the record; it does not make recommendations or provide regulatory advice. What you do with what it shows is your qualification decision, and it belongs alongside the factors this service deliberately does not cover: therapeutic-area expertise, site capabilities, your own history with the clinical investigator, and your qualification visit.
Who is behind it
Clinical Precedent was created by a father and son who brought two different careers to the same problem.
Joshua runs the company and built the platform: the data pipeline, the daily source monitoring and the application itself. He is a senior software engineer with more than twenty years of production experience in real-time simulation and training systems for defense and commercial customers.
Jerry has been in the pharmaceutical industry for more than 40 years. He shaped what the service checks and how it presents the record: which FDA actions matter to a sponsor, how a clinical-quality team reads an inspection history, and where a warning-letter-only check falls short.
The company
Clinical Precedent is a division of Elite Tech Media LLC, an Illinois software and simulation engineering firm established in 2008 and led by Joshua Chapman. Clinical Precedent is the company’s registered Illinois assumed name; Elite Tech Media LLC is the contracting party in our Terms of Service, and subscription charges appear as Clinical Precedent. The company is based in the Chicago metro area. Clinical Precedent is on YouTube, LinkedIn and X.
How we handle the record
- FDA data, checked daily. The service is built from FDA Bioresearch Monitoring records. Every source is checked every day, and the data is updated whenever new FDA information is available. The date of the latest check appears at the foot of every page.
- Documents as issued. Warning letters and disqualification documents are served as FDA issued them, unaltered, so they can be filed as evidence.
- The record, not a verdict. Nothing here is a recommendation, a score, or regulatory advice. The service shows what FDA recorded and, where the record includes it, how the site responded.
- Your data stays yours. We keep the minimum needed to run your account, watchlist and saved items, and we do not sell, share or analyze it beyond that. Details are in the Privacy Policy.
Contact
Questions, and Team and Organization subscriptions: support@clinicalprecedent.com.