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Rennes, France — May 10th, 2009
Biotrial, a leading Contract Research Organization in early development and recognized expert in QT studies, proposes through its ECG Central Laboratory division an integrated solution for collecting, managing and analyzing cardiac safety data collected in-house or externally. Biotrial also provides study design consulting, statistical analysis and reports.
“Mortara is happy to welcome Biotrial as a certified partner.” said Mark Mentzer, VP Clinical Research at Mortara. This new certification makes Biotrial one of only a few partners worldwide recognized by Mortara for rigorously adhering to the HL7 annotated ECG standard used by the FDA to manage its data warehouse. This certification enhances the company’s capability to deliver cardiovascular data which follows the strict international requirements for annotated ECGs. It is another guarantee for sponsors that the ECG data processed by Biotrial is fully compliant when submitted for regulatory review.
Jean-Marc Gandon, Biotrial CEO, commented: “Over the years Biotrial has proved its excellence in performing clinical studies; with this certification we are also demonstrating it with our ECG Central Laboratory services. Our main goal is to accompany our clients in their product development and to constantly ensure compliance with international regulations and expectations.”
“Adaptability to ever changing technological and regulatory environments is in our motto,” said Philippe l’Hostis, Head of Biotrial ECG Central Laboratory. “This new certification illustrates how we constantly strive to improve the quality of our processes at every level from ECG acquisition to submission, allowing us to strengthen Biotrial’s position as a key provider for Thorough QT studies.”
About Mortara Instrument
Based in Milwaukee, WI, Mortara Instrument, Inc. is distinguished in the field of noninvasive cardiology for innovations that are the core of the company’s complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company’s web site is
Founded in 1989 by Jean-Marc Gandon, PharmD, (President & CEO),
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.
Since the creation of their ECG and Imaging Central Laboratory, Biotrial expert cardiologists have manually read more than 350 000 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.