Drafting Clinical Trial Agreements manually requires extensive research across FDA guidelines, GCP standards, and institutional policies—often taking 6-8 hours per agreement. Attorneys must verify regulatory compliance, coordinate sponsor and investigator obligations, and ensure proper indemnification language while juggling multiple templates and legal resources. The complexity of balancing IP rights, publication policies, and budget terms creates bottlenecks that delay critical research timelines.
Clinical trial agreements require intricate balancing of regulatory compliance, risk allocation, IP protection, and operational clarity across multiple stakeholders. Manual drafting takes 12+ hours of attorney time to address FDA regulations, GCP guidelines, indemnification structures, and institution-specific requirements. Errors in regulatory provisions or risk allocation can delay trial initiation, expose parties to liability, or jeopardize compliance.
CaseMark automates comprehensive clinical trial agreement drafting with built-in FDA regulatory compliance, standardized risk allocation frameworks, and customizable provisions for study-specific requirements. The platform generates complete, execution-ready agreements in 15 minutes by intelligently extracting protocol details, applying current regulatory standards, and incorporating institutional policies. Healthcare attorneys maintain full control while eliminating repetitive drafting work.
This workflow is applicable across multiple practice areas and use cases
FDA regulatory attorneys need to draft and review clinical trial agreements that comply with FDA regulations, GCP guidelines, and investigational new drug (IND) requirements for pharmaceutical and medical device trials.
This workflow is specifically designed for FDA-compliant CTA drafting and includes built-in FDA guideline references, making it essential for attorneys specializing in FDA and food/drug law who regularly handle clinical research agreements.
IP licensing attorneys can use this workflow to address intellectual property provisions, publication rights, and technology transfer issues that arise from clinical trial collaborations between sponsors, institutions, and investigators.
Clinical trial agreements contain critical IP provisions regarding ownership of research results, patent rights, and licensing terms, which are core concerns for IP licensing practitioners working with research institutions and pharmaceutical companies.
Employment and consulting attorneys can adapt this workflow for investigator agreements and clinical research consultant arrangements, which define obligations, compensation, confidentiality, and termination terms similar to consulting agreements.
The workflow's sections on investigator obligations, compensation structures, confidentiality, and termination clauses parallel key elements in consulting and independent contractor agreements used in the healthcare research context.
Corporate counsel at pharmaceutical, biotech, and medical device companies can use this workflow to standardize clinical trial contracting processes and ensure consistent terms across multiple research sites and CROs.
In-house corporate attorneys at life sciences companies regularly negotiate and manage clinical trial agreements as part of their core responsibilities, requiring efficient contract generation and compliance oversight.
CaseMark's clinical trial agreement templates are built on current FDA regulations including 21 CFR Parts 50, 56, and 312, as well as ICH-GCP guidelines codified in ICH E6(R2). The platform automatically incorporates required regulatory provisions for informed consent, IRB oversight, safety reporting, and investigational product management. All templates are regularly updated to reflect new FDA guidance documents and regulatory changes, ensuring your agreements meet current compliance standards.
Yes, CaseMark adapts clinical trial agreements based on study phase, therapeutic area, and risk profile. The platform adjusts provisions for enrollment targets, monitoring intensity, safety reporting requirements, and insurance coverage based on protocol details you provide. Whether drafting agreements for early-phase oncology trials with significant safety monitoring or late-phase cardiovascular studies with large patient populations, the system tailors provisions to match the specific trial characteristics and regulatory requirements.
CaseMark incorporates industry-standard frameworks that protect sponsor proprietary information while preserving investigator academic freedom. The platform includes sponsor review periods (typically 30-60 days) for proposed publications, provisions preventing premature disclosure of interim or single-site data, and protections for sponsor confidential information. Simultaneously, it ensures investigators retain rights to publish final results after study completion, comply with ICMJE authorship guidelines, and present findings at scientific conferences, creating balanced provisions acceptable to both academic institutions and commercial sponsors.
CaseMark employs a mutual indemnification framework where each party assumes responsibility for harms arising from its own actions and areas of control. Sponsors indemnify for product liability, manufacturing defects, and inherent product risks, while institutions indemnify for investigator negligence, protocol deviations, and failure to obtain proper consent. The platform includes procedural requirements for claim notice, defense control, and settlement approval, along with appropriate insurance requirements based on trial risk profile. This balanced approach is widely accepted by both academic institutions and pharmaceutical sponsors.
CaseMark allows you to upload institutional policies, standard terms, or prior agreement templates that the AI analyzes and incorporates into new agreements. The platform can adapt to institution-specific requirements for overhead rates, payment terms, IRB procedures, conflict of interest disclosures, and technology transfer provisions. You can save institutional preferences as templates for future use, ensuring consistency across multiple clinical trial agreements while maintaining compliance with your organization's governance requirements and risk management policies.