Clinical Trials Logistics
Eurofins BioPharma Product Testing provides logistics for clinical trials considering always the specific needs of the Sponsor in each step of the product development and/or marketing: R&D, Clinical studies phase I to IV.
The studies are carried out by professionals with a deep knowledge of pharmaceutical and shipment regulations and state-of-the-art equipment.
We provide detailed reports of the set up, shipment, manufacturing, storage and distribution performing the studies according to GDP and GMP regulations.
- Importation of products for clinical trials
- Batch release
- Secondary packaging
- Storage in control conditions
- Software for stock control
- Storage attestation
- Acknowledgement of receipt for each entering or leaving product
- Reactivity for delivery within 24/72 hours in Europe
- Validated packaging procedures for shipment: controlled temperature and follow up of temperature
- Personnel Training
Collection of Biological Products
- Sampling kit manufacturing
- Transport regulation of dangerous goods
- Authorized transport packaging
- Storage in controlled conditions (-20°C/-80°C)
- Serotheque management
Return from Investigator Sites
- Package Collection
- Return Stock Control
- Storage Certificate
- Destruction after Authorization by Sponsor
The facilities are equipped with large climatic chambers with different temperature and humidity conditions and a number of refrigerators and freezers that allow performing storage according to specific regulations for each type of project (ICH, ISO, CIPAC, etc.).
Storage conditions monitoring includes continuous recording of temperature using validated software to manage data obtained from the measuring probes. The installations are subject to qualification at least once a year.
Available Storage Conditions
- 20°C + 5°C
- 4°C + 3°C
- -20°C + 5°C
- -80°C + 5°C