Clinical Supply services
Clinical Supply services
Our clinical trial units operate in close collaboration with formulation development and commercial manufacturing to take advantage of the full range of capacities, resources and complete big pharma infrastructure offered by all of our facilities.
They are comprised of:
>> Clinical Manufacturing
>> Comparator Procurement
• Label Printing & Labeling
• 100% inspection of all clinical labels (four-eye principle)
• Documented 100% reconciliation
• Generation of randomisation lists
• Code-breaking envelopes
• Multi-lingual booklet labels & wrap-around labels
Packaging / Pre-production Service
• Interpretation of study protocols & conversion into optimized packaging design
Secondary Packaging
•Syringes, vials & ampoules, visit boxes, patient kits, centre boxes, shipping boxes, graphic packaging design
Analytical / QA-Service
• In-house lab • Analytical method development, transfer and validation • Stability tests according to ICH • Release testing • Issuance of CoA • QP release
Storage
• Dedicated shipping warehouse area • Commercial warehouse • Cold Storage Room @ 2-8°C • Cold Storage Room & Freezer Storage @ -20°C
Distribution
• Worldwide distribution • IVRS/IWRS • Shipment tracking with modern communication systems • Cold chain distribution management, including refrigerated & frozen shipment • Data logger system • Return drug reconciliation & management • Certified destruction
