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Rennes, France, March 3, 2009-QT studies are crucial in clinical research. For the past 20 years, Biotrial has been recognized by pharmaceutical companies worldwide as an expert in this area. Not only because of the cutting edge technology of its state-of-the-art clinical pharmacology unit, the unique expertise of its highly trained and committed staff, and its large therapeutic and scientific experience, but also because of the excellence reached today by its ECG and Imaging Central Laboratory.
Since the creation of their ECG and Imaging Central Laboratory, Biotrial expert cardiologists have manually read more than 350 0000 ECGs and measured more than one million QT intervals. More than 120 cardiac safety studies have been directly managed in house or outside since the implementation of digital ECGs.
“QT studies are key in the development process. The pharmaceutical industry, now more than ever, is aware of the importance of assessing cardiac safety for evaluating the re-polarization effects of new drugs,” said Jean-Marc Gandon, Biotrial CEO. “We’re experiencing a significant increase in the demand for QT studies from the Top 10 as well as midsized pharmaceutical and biotech companies.”
“The regulatory authorities have made clear that the process of drug development should include a QT study. But to succeed in gathering high-quality data and to fulfill regulatory requirements in this area you need the right people, the right equipment and the right expertise,” said Philippe l’Hostis, Head of Biotrial ECG Central Lab. “We are happy to serve our customers with excellence in these three areas. We are thankful for the trust that our sponsors have put in us, and are celebrating this important milestone confirming the continuing growth of our ECG central laboratory activity.”
Biotrial’s ECG central laboratory proposes an integrated solution for collecting, managing, and analyzing cardiac safety data collected in-house or externally, as well as study design consulting and statistical analysis and reports. Biotrial’s ECG central laboratory IFA commitment is: Integrity of data delivered, Flexibility to sponsor’s needs and Adaptability to ever changing technological and regulatory environment.
Founded in 1989 by Jean-Marc Gandon, PharmD, (President & CEO), Biotrial (www.biotrial.com) is an independent and privately owned CRO. With 150 beds and a staff of 250 in several subsidiaries in France and the UK, Biotrial runs over 80 studies per year, either in their own clinics in Paris and Rennes, or in cooperation with hospital specialists and general practitioners. With a large range of services from Phase I studies, Clinical Trial Management Phase II-IV, Oncology, Data Management, Biostatistics, Central Labs (ECG, Imaging), Medical Writing, Non-Clinical Pharmacology, QA & advice in Regulatory Affairs, Biotrial can manage every step of your development process.