MRC Sleep Study - Purchase of IMP to include the following activities:
- Support with regulatory approvals (preparation of IMPD)
- Sourcing of Trazodone 100mg tablets & Zolpidem 5mg tablets
- Over-encapsulation of active products & Manufacture of matched
placebo capsules)
- Packaging of products in to bottles, designing and providing blinded labels in accordance with Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 Amendment to Regulations
- Hold appropriate MIA(IMP) authorisation
- QP Certification for use in the UK
- Storage & Distribution to UK Pharmacy
- Ensure full traceability of materials and processes, including batch release certificates and audit trails
- Conducting such work as instructed, and in accordance with any relevant protocol / policy / work-instruction, for the duration of the contract.
- Compliance with Medicines for Human Use (Clinical Trials) Regulations 2004 and the 2025 Amendment to Regulations when they are applied in April 2026 plus any other applicable regulatory requirements