Biotrial has a Pharmacy authorized by the French Medicine Agency (ANSM) for supplying, packaging, labelling and stocking of the experimental study products.
For reasons of security and privacy, the pharmacy is a restricted area accessible only to the pharmacy staff. All storage rooms (ambient, cold or frozen storage) are under control of temperature and humidity (probes linked to the validated software Oceasoft) and are divided in several parts:
- the receipt room for the storage of study drugs before administration
- the return room for the storage of study drugs after administration (used and unused study drugs)
- the quarantine area
- the retention samples area
- the controlled drugs area
Study medication can be received in bulk as we have a large experience in repackaging or reconstitution of the IMP for clinical trials.
All the pharmacy processes (including receipt, accountability, reconciliation, destruction, repackaging, etc.) are performed under GMP and are described in our specific SOPs.
Systematically 1 pharmacist and 1 pharmacy assistant are dedicated to each project.
All the staff is annually trained to GMP/GCP.
We can manage multiple types of formulation: tablets, capsules, oral solution, injectable solution, etc., as we have dedicated premises (repackaging lab, under pressure room with isolator or laminar flow hood) and complete material on site.
We can help our client to design the IMP preparation or the blinding process.
A dedicated pharmacy manual (describing all pharmaceutical operations) is always written for each study performed at Biotrial and could be validated by the client.
Do not hesitate to contact us for advice.