As Outsourcing-Pharma.com reported yesterday, the new site is a Phase I unit designed for early development studies.
According to Francois Peaucelle, General Manager, Biotrial, the company has started activities with studies for European and American biotech, the pharma industry, and US generics companies.
“We aim to perform 50 clinical studies per year on healthy volunteers for the pharmaceutical research,” Peaucelle told Outsourcing-Pharma.com.
The new site is the result of a $30m investment and the company expects the future annual turnover to reach $30m. There is also the possibility of additional development on the same site, allowing for increased capacity.
In a word from the president at the opening ceremony, Jean-Marc Gandon said that with more than 50% of early clinical trials performed in the US, “it is only logical to follow the market – it is the FDA which is the principal motor behind the majority of regulatory changes all over the world.”
Overall, Peaucelle told us that group activity is growing – with the exception of Phase I activities in France. When asked how the company is working to move past the issues surrounding the site, which conducted the trial during which one patient died, Peaucelle focused on transparency.
“From the beginning, the desire of our company is to be transparent on all the facts, despite all mediatics or political assertions (sometime far from the truth),” he said.
Following three investigations, with one still pending, there have been no charges brought against Biotrial and the company has not been the object of any administrative sanction, Peaucelle reiterated.
“We have adapted all our processes as recommended by the French Authorities and we collaborate fully with the French Judicial authorities, but also with the scientific community to improve the understanding of what occurred and improve the research safety in the world,” he explained.
Peaucelle said this transparency has helped Biotrial keep its relationship with its clients, and that “professionals of pharmaceutical research” continue to trust in the company’s “skills and high level performance.”