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Clinical Trial Agreement

Draft Clinical Trial Agreements in Minutes, Not Days

15 minutes with CaseMark

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2. Upload the files you want analyzed.

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Workflow

Clinical Trial Agreement

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Workflow

Clinical Trial Agreement

Overview

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.

How it works

  1. 1. Upload your documents

  2. 2. AI analyzes and extracts key information

  3. 3. Review and customize the generated content

  4. 4. Export in your preferred format (DOCX, PDF)

What you get

  • Parties and Recitals

  • Definitions

  • Scope of the Study

  • Sponsor Obligations

  • Institution and Investigator Obligations

  • Compensation and Budget

  • Confidentiality

  • Publications and Intellectual Property

  • Indemnification and Insurance

  • Term and Termination

  • Governing Law and Dispute Resolution

  • Miscellaneous Provisions

  • Signatures

What it handles

  • Parties and Recitals

  • Definitions

  • Scope of the Study

  • Sponsor Obligations

  • Institution and Investigator Obligations

  • Compensation and Budget

  • Confidentiality

  • Publications and Intellectual Property

  • Indemnification and Insurance

  • Term and Termination

  • Governing Law and Dispute Resolution

  • Miscellaneous Provisions

  • Signatures

Required documents

  • Study Protocol

    Complete clinical trial protocol including study design, endpoints, patient population, and procedures

    .pdf, .docx

Supporting documents

  • Investigator Brochure

    Comprehensive information about the investigational product including safety data and pharmacology

    .pdf, .docx

  • Budget Template

    Itemized budget showing per-subject costs, startup fees, and procedure-specific compensation

    .xlsx, .pdf, .docx

  • Institutional Policies

    Institution-specific requirements for clinical research agreements, IRB procedures, or conflict of interest policies

    .pdf, .docx

  • Prior CTA Examples

    Previous clinical trial agreements from the institution or sponsor for reference and consistency

    .pdf, .docx

Why teams use it

Generate FDA and GCP-compliant agreements in 12 minutes vs. 6+ hours manually

Automatically extract study details from protocols to populate scope and objectives

Access verified legal sources for sponsor obligations, indemnification, and IP provisions

Ensure regulatory compliance with built-in FDA guideline and bar association references

Standardize confidentiality, publication rights, and termination clauses across all CTAs

Questions

How does CaseMark ensure clinical trial agreements comply with current FDA regulations?

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.

Can the platform handle different types of clinical trials like Phase I, II, or III studies?

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.

How does CaseMark balance sponsor IP protection with investigator publication rights?

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.

What indemnification structure does CaseMark use for clinical trial agreements?

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.

How does the platform handle institution-specific requirements and policies?

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.

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