Clinical Trial Consulting Services

Biomedical Systems provides Sponsors with a full slate of consulting services for Cardiac Safety & Efficacy, Imaging and Respiratory clinical trials. Lead by our Chief Medical Officer, Dr. Pierre Maison-Blanche, and our Chief Scientific Officer, Dr. Tim Callahan, our team of international experts provides consult for;

Protocol Development for Diagnostic Services
Medical Writing
Biostatistics
Report Writing

High Level ECG Data Review

In addition, Biomedical Systems can provide Sponsors with a High Level Data Review for Centralized ECG Data. The object of which is to review the data like an Regulatory Reviewer would. Dr. Maison-Blanche and Dr. Callahan provide the thorough review of data for this program.

       Review uses both standard techniques and exploratory analyses

       Allows Biomedical Systems to understand and respond to data
       issues potentially raised by the FDA

       ECG data review occurs at end of study

       ECG data review includes intra- and inter-subject variations

       ECGs overall quality and ECGs with measurements that are outliers

Dr. Maison-Blanche earned his MD in 1981 from the University of Paris and specialized in Cardiology at Lariboisière Hospital. For the past thirty years, Dr. Maison-Blanche has performed angiography and clinical research in the cardiovascular therapeutic area in the Cardiology Department at Lariboisière Hospital. Dr. Maison-Blanche’s clinical specialty is non-invasive cardiac electrophysiology and he organized the first ECG Laboratory at Lariboisière Hospital under the leadership of Dr. Philippe Coumel.

Dr. Timothy Callahan received his Ph.D. from Capella University in Interdisciplinary Studies with a concentration in Research Methodology. He has conducted research in Silent Myocardial Ischemia at the National Institutes of Health in Bethesda Maryland. Dr. Callahan has been in the research industry for approximately 20 years. An expert in diagnostic testing, he co-authored 2 patents in QT interval analysis and has authored many abstracts and publications. Dr. Callahan is a frequent speaker at Pharmaceutical Industry functions, including acting as the co-chair of the October, 2002 DIA “ECGs in Clinical Trials” meeting.