Product methodology
Clinical Trial Site Risk Index
Source contract, normalization path, entity-graph join, refresh posture, and publication limits for this Branmoor product.
Status
In service. This product has a functional preview or paid engagement surface in the current site. The full licensed product may still include private exports, alerts, APIs, or buyer-specific diligence that are not exposed publicly.
Distribution Scope
Nationwide; TN research sites; Nashville/Vanderbilt trial-site risk
Product Question
Scores clinical trial sites for inspection, payment, adverse-event, and sponsor risk.
Primary 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
Entity-Graph Join
NCT ID, site `npi`/address, sponsor `irs_ein`, investigator `npi`.
Publication Rule
Branmoor does not treat raw public records as the product. A surface is publishable only when the source record is dated, normalized, source-linked, and joined to the relevant Branmoor entity identifiers with enough confidence to state the limits of the result.
Current Methodology Note
v1 surfaces every active U.S. clinical trial site with activity volume, dominant sponsor, unique sponsor count, and phase distribution — the operating-volume substrate from ClinicalTrials.gov. The paid Risk Index layer adds FDA Form 483 / warning letter history per PI/institution, BIMO inspection results, CMS Open Payments concentration, FDA debarred-persons cross-reference, and FAERS site-indexed adverse event patterns, weighted into a composite risk score calibrated against historical trial-failure outcomes.
Limits
Coverage follows the underlying source. Missing state portals, gated APIs, PDF-only filings, suppressed fields, lagged agency refreshes, and entity-name ambiguity can all limit product completeness. Pending products are not marketed as live until those limits are documented on the product surface.