Clinical Supply Agreement Template
A Clinical Supply Agreement is a crucial legal document that establishes the terms and conditions for manufacturing and supplying pharmaceutical products for clinical trials. This agreement ensures compliance with Good Manufacturing Practice (GMP) standards while clearly defining the responsibilities between the manufacturer and the trial sponsor.
What This Template Is For
This template is designed for pharmaceutical companies, contract manufacturing organizations (CMOs), and clinical trial sponsors who need to formalize their manufacturing and supply relationship. It covers essential aspects including quality standards, production specifications, delivery terms, and regulatory compliance requirements for clinical trial materials.
When To Use This Template
Use this template when:
- Engaging a contract manufacturer for clinical trial materials
- Setting up supply arrangements for investigational products
- Establishing quality control and testing requirements
- Defining manufacturing schedules and delivery terms
- Documenting compliance with regulatory requirements
How To Customize It
Follow these steps to customize the agreement:
- Insert specific product details and manufacturing specifications
- Define quality control procedures and acceptance criteria
- Specify production timelines and delivery schedules
- Add relevant regulatory compliance requirements
- Include pricing and payment terms
- Customize liability and indemnification clauses
- Add confidentiality provisions
Common Use Cases
This agreement is commonly used in:
- Phase I-III clinical trials
- Contract manufacturing relationships
- Multi-site clinical studies
- International drug development programs
- Biotech product development
Best Practices
Follow these guidelines:
- Clearly define product specifications and quality standards
- Include detailed manufacturing process requirements
- Specify batch release criteria and testing requirements
- Address stability testing and storage conditions
- Define clear timelines for delivery and acceptance
Template Variations
Common variations include:
- Small-scale clinical trial supply agreements
- Large-scale commercial manufacturing agreements
- Research-phase manufacturing agreements
- Technology transfer agreements
Success Stories
This template has been successfully used in:
- Phase III oncology drug trials
- Multi-site vaccine studies
- Biological product development
- International clinical programs
Frequently Asked Questions
What are the essential elements of a clinical supply agreement?
Essential elements include manufacturing specifications, quality requirements, delivery terms, pricing, regulatory compliance obligations, and liability provisions.
How long should a clinical supply agreement be valid?
Typically, these agreements cover the duration of the clinical trial plus additional time for stability testing and potential extensions, usually 2-5 years.
What quality standards should be included?
The agreement should reference GMP standards, specific quality control procedures, testing requirements, and acceptance criteria for manufactured products.
How should pricing be structured?
Pricing typically includes manufacturing costs, testing fees, storage charges, and may include volume-based pricing tiers.
What regulatory requirements should be addressed?
The agreement should cover FDA/EMA compliance, GMP standards, documentation requirements, and audit rights.