Connect every clinical trial in your portfolio to FDA drug approvals, EMA medicines, medical device classifications, safety signals, and the patent records the FDA publishes — automatically enriched from 18+ authoritative databases.
Regulatory intelligence and clinical trial data live in separate worlds. Teams manually cross-reference FDA approvals, EMA authorizations, exclusivity records, and device classifications against their trial portfolios. This takes hours, introduces errors, and means critical competitive signals are discovered too late.
ClinicaLister automatically links your followed clinical trials to relevant drugs and devices across FDA and EMA databases. AI-powered matching identifies connections, every link carries a confidence score you can check, and enrichment adds safety, substance, and — where the FDA publishes them — patent and exclusivity records.
The Drug & Device Intelligence module provides four integrated views:
Confirmed drug-trial associations with full FDA/EMA regulatory data
AI-identified potential matches with confidence scores and community validation
Confirmed device-trial associations with classification, safety, and GUDID data
AI-identified device matches pending community validation
Access regulatory data on 29,600+ FDA-approved drug products, enriched with Orange Book therapeutic-equivalence data and the patent and exclusivity records the FDA publishes.
Coverage is thin and we publish the number: of 29,808 FDA drug records we hold patents on 4.4% and exclusivity end-dates on 1.8%. That supports a per-drug lookup where the FDA publishes the data — not a portfolio patent-cliff or loss-of-exclusivity timeline. A full Orange Book feed is not yet ingested.
European Medicines Agency data from EPAR covering 2,700+ centrally authorized medicines across EU member states.
Comprehensive medical device regulatory data covering 177,000+ FDA device submissions across all major submission pathways.
ClinicaLister's AI engine identifies potential drug-trial and device-trial relationships using advanced matching algorithms. Every suggestion is transparent, scored, and community-validated.
Reads trial titles, summaries, eligibility, and intervention text
Candidate drugs and devices matched across multiple independent signals
Every link graded High, Medium, or Low confidence
Each link is automatically quality-checked before it's surfaced
Verified links can be confirmed by the community
Every drug and device link is enriched by cross-referencing multiple authoritative databases:
UNII codes, molecular formulas, molecular weight, CAS numbers, substance class
FDA adverse event reports — event narratives, patient demographics, severity outcomes
Recall classification, status, recalling firm, reason, distribution pattern
Product code classifications, medical specialty, device class, review panel
Device identifiers, brand names, MRI safety, latex content, sterilization methods
Therapeutic equivalence, patent listings, exclusivity data for FDA-approved drugs
National Drug Code product listings with marketing dates, DEA schedule
Cross-references to EU trials — trial numbers, status, phase, recruiting states
FDA-approved drug labeling, package inserts, medication guides, and prescribing information
National Average Drug Acquisition Cost — retail pharmacy pricing data for cost intelligence
Active FDA drug shortage tracking with supply status and estimated resolution dates
Trial-linked publications providing evidence context and research citations
Physician and teaching hospital payment data from pharmaceutical and device manufacturers