Clinical Trial Materials Management
Eurofins BioPharma Product Testing network of laboratories dedicates a large infrastructure to its clinical trial logistics service, including a storage area of 6,500 m2 and a technical platform recognized for its quality assurance. In addition to a wide range of storage conditions at controlled temperatures, Eurofins BioPharma Product Testing provides pharmaceutical manufacturing operations, distribution and logistics of treatment units, medical devices and documents for clinical trials.
Clinical Good Manufacturing Practice status activity
Eurofins BioPharma Product Testing provides the following manufacturing operations:
- Medication Sourcing
- Importation of Drug Substances and Drug Product for clinical trials from and outside the European Community
- QP release with worldwide manufacturer site audit and batch certification
- Manufacturing (capsule filling and over encapsulation)
- Solid forms primary packaging (blister packs and pillboxes)
- Liquid forms primary packaging (aseptic Fill and Finish)
- Secondary packaging created in order to best meet the specific requirements of the study
- Label design and printing, clinical labeling (booklet label up to 40 different languages, detachable flap label)
- Randomization and labeling of boxes
- Stability study of clinical batches (storage and analysis) and extension of expiry date
Clinical Good Distribution Practice status activity
Eurofins BioPharma Product Testing network of laboratories supports all operations for the distribution of your investigational products:
- Reception of investigational Drug Products for clinical trials
- Storage in controlled conditions (-80°C, -20°C, 4°C, 20°C)
- International logistics with cold chain management to investigative centers (hospitals and medical offices) for multicenter clinical studies
- Web interface for stock and shipments management
- Return, reconciliation and destruction of remaining Drug Product
- Establishment of temperature monitoring systems with the appropriate software for metrological control in investigative centers
- Qualification of freezers, refrigerators and other forums in investigative centers
- Validated insulated transport packages used in summer, winter, midseason
Logistics services
- Large qualified facilities (Paris and Lyon) in controlled conditions (-80°C, -20°C, 4°C, 20°C)
- International logistics with strong reactivity (shipment 24/7 in Europe)
- Import / export coordination with customs and authorities
- Customer clearance facilitation in every country of the world
- Expertise in Cold Chain Management
- Temperature traceability during storage
- Temperature during shipment with validated insulated transport package
- Batch tracking
- Dedicated Quality System
Logistics services for biological samples
- Sample collection kit design
- Supply of sampling kits to customers
- Dedicated pickup and delivery to labs in compliance with regulations (ADR, IATA)
- Storage in controlled conditions (-80°C to -20°C) with temperature traceability
- Management of Investigational sites (inventory, resupplies…)
- Laboratory Services & Biomarker analysis through Eurofins network
- Destruction of biological samples
