|Headquarters|| Rennes, Nantes & Mulhouse, France
London, UK Newark, NJ, USA Montreal, QC, Canada
|Key people||Jean-Marc Gandon, President & CEO|
|Number of employees||201-500 employees|
Biotrial's mission is to provide our sponsors with high-quality pharmacology services, adding value to their projects by working together and meeting all needs throughout the development process.
To ensure this mission, Biotrial advocates controlled extension of its facilities and prides itself in developing long-standing relationships with our sponsors.
With experience gained from over 20 years activity, Biotrial has established flexible and efficient working practices ensuring client satisfaction – workflow tailor-made to keep to deadlines and budget terms as well as rigorous quality control covering every detail.
The active participation of key members of staff in all projects ensures the quality of our services.
- Non-clinical Pharmacology
- Early Development & Translational Medicine
- Patient Studies
- Core Lab
- Regulatory Affairs & Pharmacovigilance
Regulatory Affairs & Pharmacovigilance Experience
- Submissions to the French Medicines Agency (ANSM) and other Regulatory Agencies in Europe
- Participation in ANSM working groups and knowledge of ANSM procedures
- In-depth expertise with the European Clinical Trial Directive
Regulatory Affairs Services
- Advice in Submission strategy
- Certified translations of regulatory and clinical documents
- Preparation and submission of Clinical Trial Application (CTA) documents
- Preparation of Investigational Medicinal Product Dossier (IMPD)
- Preparation of Investigator Brochure (IB)
- Management of potential questions raised by ANSM or other European Authorities
- Management of substantial amendments
- Eudravigilance management (initial registrations, IMP declaration, SUSAR declarations)
- Serious Adverse Event (SAE) collection and processing
- Suspected Unexpected Serious Adverse Reactions (SUSARs) submission to competent authorities and ethics committees
- Development Safety Update Report (DSUR) or Periodic Safety Update Report (PSUR) writing and submission
- Regulatory submission
- Preparation and submission of a CTA in one week
- Regulatory monitoring
- Regulatory Consultancy
Top 5 Recent Tweets
|April 17, 2023||BiotrialUS||Our clinical trials undergo rigorous monitoring to ensure the well-being of our participants. Learn more about Biot… https://t.co/PjDBlhAwfl|
|April 17, 2023||Biotrial||Join our experts at AACR 2023 until April 19th. Stop by booth #2771 and have a chat with us!
|April 14, 2023||Biotrial||Biotrial follows the CDISC guidelines for data formatting including SEND for non-clinical data submitted to the FDA… https://t.co/vsxMEiKE1V|
|April 13, 2023||Biotrial||[BIOTRIAL'S EMPLOYEE SPOTLIGHT] ★ Today, we would like to highlight one of our employees: Laura Galland! Come and… https://t.co/Y3RMPss7PA|