Biotrial

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[1]
Type Private
Founded 1989
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


Overview

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.[1]

Services

  • Non-clinical Pharmacology
  • Early Development & Translational Medicine
  • Patient Studies
  • Oncology
  • Bioanalysis
  • Core Lab
  • Biometrics
  • 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


Pharmacovigilance services

  • 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

Expertise

  • Regulatory submission
  • Preparation and submission of a CTA in one week
  • Regulatory monitoring
  • Regulatory Consultancy



Top 5 Recent Tweets

DateAuthorComment
December 12, 2018BiotrialToday, Biotrial Senior Statistician Cécile Lerner attended the @EFSPItweet Decision-making in #drugdevelopment even… https://t.co/3VlpIj7amh
December 10, 2018BiotrialWe are happy to share our recently published research paper focusing on Parkinson's Disease-related neuropsychiatri… https://t.co/1f8rdUTVRq
December 06, 2018BiotrialBiotrial has exciting opportunities available for highly motivated Business Development Managers to join us in the… https://t.co/pHwsJrU4Hf
December 05, 2018BiotrialStop by booth 18 at #OCTEastAsia to discover the advantages of partnering with Biotrial for your projects!… https://t.co/V6om5nylfN


Top 5 Recent News Headlines

Top 5 Lifetime Tweets

Top 5 Lifetime News Headlines

  1. https://www.biotrial.com/

Verification history