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
September 17, 2018BiotrialGet the scoop on Risk-Based Monitoring from booth 407 at #SCDM2018, Sept 23-26! Until then, learn more about #RBM b… https://t.co/LMl2cXkoDL
September 13, 2018BiotrialRisk-based monitoring (#RBM) is defining the future of clinical decision making. Drug developers need to know what… https://t.co/W8p3l67unI
September 13, 2018theworldofCROsWhy Drug Developers Can't Ignore the Advantages of RBM https://t.co/eUNkbEWyqz


Top 5 Recent News Headlines

Top 5 Lifetime Tweets

Top 5 Lifetime News Headlines

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

Verification history