Clinical Operations & Pharma 8 min read

Automating Clinical Trial Patient Eligibility Screening Against FDA & EMA Protocols

BioPharma Regulatory Unit August 5, 2026

Accelerating Clinical Trial Enrollment & Protocol Adherence

Contract Research Organizations (CROs) and principal investigators face high patient drop-out rates when manual eligibility screening misses subtle protocol exclusion rules.

AI Protocol Eligibility Audit Engine

The ContextSkeleton Clinical Trial Protocol Resolver ($850/mo) evaluates anonymized patient profiles against protocol criteria:

  • Biomarker & Lab Threshold Validation: Verifies EGFR, ALK, or organ function lab values.
  • Washout Period Compliance: Flags prior chemotherapy or systemic therapy timing conflicts.
  • Eligibility Scorecard: Generates instant Pass/Fail recommendations with regulatory rationale.
Clinical Trial Protocol Resolver

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