Site-level risk score for every active clinical trial in the U.S. — combining ClinicalTrials.gov, FDA 483s, Open Payments, and adverse event histories.
What it is
Clinical Trial Site Risk Index is a continuously updated risk score for every active U.S. clinical trial site. The score combines investigator history (FDA Form 483s, warning letters, debarment), industry payment patterns (CMS Open Payments), site enrollment performance across prior trials, adverse-event reporting patterns indexed back to the site, and the inspection history of the institution.
Pharma sponsors choosing Phase II and Phase III sites today rely on CRO recommendations and prior relationships. A site with a latent data integrity issue can kill a pivotal trial — delay, FDA refusal-to-file, and 2–3 years of program impact. Branmoor gives the sponsor — or the sponsor's CRO doing site selection on her behalf — an independent risk score before the contract goes out.
Two buyer cohorts. Pharma sponsors and large CROs (IQVIA, Parexel, ICON, Labcorp Drug Development) use it for site selection diligence. Plaintiff firms working trial-injury cases use it for the inverse: identifying sites with the risk-marker pattern post-incident. Sold under named institutional license.
Primary data sources
- ClinicalTrials.gov — Active trials, sites, principal investigators
- FDA Form 483 and warning letter database — Investigator and institution inspection findings
- FDA Bioresearch Monitoring Program inspections — BIMO inspection results and classifications
- CMS Open Payments — Industry payments to physician investigators
- FDA debarred persons list — Debarment and disqualification
- FAERS site-indexed adverse events — Site-attributed adverse event reporting patterns
Buyers
- Pharma sponsors (site selection diligence)
- Large CROs (IQVIA, Parexel, ICON, Labcorp Drug Development, PPD, Syneos)
- Plaintiff firms working clinical trial injury cases
- Site management organizations benchmarking
- Clinical trial insurance underwriters
Methodology
Risk score components are weighted from a calibrated model; weights and rationale are disclosed. False-positive controls are baselined against published BIMO outcomes.
Inquire about access
Clinical Trial Site Risk Index is sold under named institutional license. Pricing is scoped per engagement. Reach out with the institutional context (organization, role, intended use) and we'll route a relevant scope of work.