The Clinical Supply Agreement is essential for organizations conducting clinical trials in Singapore, establishing the framework for the supply of investigational products and related materials. This agreement type is crucial for ensuring compliance with Singapore's strict regulatory environment, including HSA guidelines and Good Manufacturing Practice requirements. It typically covers quality standards, manufacturing processes, testing procedures, storage conditions, and delivery specifications, while addressing local regulatory requirements for clinical trial materials.
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Key Requirements PROMPT example:
Clinical Supply Agreement
"Need a Clinical Supply Agreement for a Phase II oncology trial where our Singapore-based pharmaceutical company will receive drug supplies from a manufacturer in Germany, with first delivery required by March 2025 and specific temperature control requirements."
1. Parties: Details of the supplier and recipient entities, including registration numbers and addresses
2. Background: Context of the agreement, including the clinical trial details and purpose of supply
3. Definitions: Key terms used throughout the agreement including Product, Specifications, GMP, Clinical Trial
4. Supply Obligations: Core obligations regarding the supply of clinical materials, including quantities, timelines
5. Quality Requirements: GMP compliance, specifications, testing requirements
6. Delivery and Storage: Delivery terms, storage conditions, handling requirements
7. Regulatory Compliance: Compliance with applicable laws, permits, licenses
8. Payment Terms: Pricing, payment schedule, invoicing requirements
9. Confidentiality: Protection of confidential information exchanged
10. Term and Termination: Duration of agreement and termination provisions
1. Manufacturing Change Control: Process for managing manufacturing changes when supplier is manufacturing the product
2. Technology Transfer: Terms for transfer of manufacturing technology when manufacturing process needs to be transferred
3. Safety Reporting: Procedures for adverse event reporting when supplier has direct involvement in safety monitoring
4. Insurance: Insurance requirements and coverage when specific insurance coverage is required
1. Product Specifications: Detailed technical specifications of the clinical supplies
2. Quality Agreement: Detailed quality requirements and responsibilities
3. Pricing Schedule: Detailed pricing information and structure
4. Supply Schedule: Delivery timeline and quantities
5. Technical Transfer Protocol: Details of technology transfer process if applicable
6. Safety Data Exchange Agreement: Procedures for safety data exchange between parties
7. Storage and Handling Requirements: Detailed storage and handling specifications
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