• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Biotrial contests Marisol Touraine’s statement, disagrees with IGAS

Biotrial contests Marisol Touraine’s statement, disagrees with IGAS

May 26, 2016
CenterWatch Staff

Biotrial, a medical research center in Rennes, France, has released a statement expressing shock over Health Minister Marisol Touraine’s statements regarding a recent trial that caused the death of a patient.

Biotrial received the General Inspectorate of Social Affairs’ (IGAS) final report at the same time the press conference—which Biotrial was not invited to attend—was ending. This report had, however, been previously provided to the media on Sunday evening.

Regarding the plan of action required by the Social Affairs and Health Minister, Biotrial had already begun to put one into place following exchanges with the French National Agency for the Safety of Medicines and Health Products (ANSM). In addition, the ANSM and the Regional Health Agency’s (ARS) recommendations were immediately put into place after the accident in January 2016.

According to Biotrial, the clinical research center did not wait for the IGAS report and the Health Minister recommendations to make volunteer care improvement its utmost priority.

Regarding the General Inspectorate of Social Affairs’ report, Biotrial contests the conclusions from the IGAS final report which, in order to stay consistent with the report that was hastily published in February, would not allow itself to include the input provided by Biotrial. The center deplores the methods, which it considers contrary to legal procedures that were used to put together the report. Biotech believes this has “remove[d] all of its credibility.”

Biotrial will submit to the Health and Social Affairs Minister its plan of action, which is already in place.

Biotrial stated the Portuguese Laboratory Bial’s compound, by it unexpected and unpredictable toxicity, was at fault for the accident.

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • Virtual Doctoer

    Simple Changes Can Make Trials More Patient Friendly

  • Drug approval

    Two-Thirds of Trial Subjects for Drug Approvals Are Outside the U.S.

  • VaccinewithNeedle-360x240.png

    Rules of Vaccine Approval May Be Changing, But Statistical Analysis Tools Remain Constant

  • AskTheExperts-360x240.png

    Ask the Experts: Trial Operations Adjustments in a Remote World

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing