PRESS RELEASE - February 25th, 2016
Rennes Clinical Trial Accident: Clarifications from Biotrial
Rennes, February 25th, 6:00 PM
Following different articles published, especially in Le Figaro, Biotrial reiterates that it is not a pharmaceutical company, but a clinical research company, service provider for international pharmaceutical companies. The company is certified by the Ministry of Health and its studies are strictly regulated by international guidelines and the trials are always approved by the ANSM (National Agency for the Safety of Medicines and Health Products) prior to being performed.
As such, Biotrial cannot, alone, be the only name associated with the painful events which led to the death of the volunteer. Using a shortcut to damage the company, the event is often presented as “The Biotrial Case”. It is important to remember that Biotrial is not responsible for the death of the volunteer. The accident happened during the clinical trial for the molecule BIA 10-2474, performed for the Portuguese pharmaceutical company, Bial.
This confusion is harmful to the company and in order to preserve its interests, Biotrial will be obligated to bring legal action to repair damage suffered.
Furthermore, Biotrial reiterates that it in no way participated in the non-clinical/animal trials for this molecule. In addition, Biotrial never performs animal toxicology studies. Only the sponsor, the Portuguese pharmaceutical company, Bial, has all of the information regarding the results of tests performed and is able to provide information on how they were performed and the detailed results.
Biotrial remains in contact with the volunteers who participated in the study and continues to provide the assistance and support needed.
Guillaume Didier +33 6 74 08 27 17
BIOTRIAL is a private centre for medical research licensed by the Ministry of Health (based in Rennes and present internationally). It conducts Phase I clinical trials, i.e. for a first administration to humans, on behalf of laboratories and biotechnology companies.