Workflow
Clinical Trial Investigator Agreement
Overview
CaseMark's Clinical Trial Investigator Agreement skill drafts comprehensive, FDA-compliant agreements between sponsors or CROs and principal investigators or institutions for regulated drug, biologic, and device studies. The AI handles the full complexity of clinical trial contracting—from regulatory flow-down obligations and IRB requirements to payment compliance, publication rights, and indemnification—producing a ready-to-review agreement in minutes.
Drafting clinical trial investigator agreements is one of the most time-consuming bottlenecks in study startup. Each agreement must weave together complex FDA regulations, ICH GCP standards, HIPAA requirements, institutional policies, and financial compliance rules—often requiring multiple rounds of legal review and negotiation that delay enrollment by weeks or months.
CaseMark automates the drafting of investigator agreements by intelligently assembling regulatory-compliant provisions based on your study's specific parameters. The AI identifies the correct regulatory track, incorporates site-specific policies and institutional constraints, and produces a comprehensive agreement with built-in compliance verification—dramatically accelerating study startup while reducing legal risk.