Cardiac Safety » Clinical Trial Services

Biomedical Systems participated in our first pharmaceutical clinical trial in 1985. Up until that time, the company had been one of the pioneers of Holter service and equipment to physicians, hospitals and clinics in the United States. Biomedical Systems knew that if we were to bring value to Sponsors in this new area, we would have to show that same pioneering, innovative attitude to this industry. If not, we would run the risk of being just another “me-to” company.

Biomedical Systems conducted an in-depth analysis of the methodology being used in clinical trials in 1985. We saw better, more efficient ways to acquire, analyze and manage data collected at clinical sites. Methods that produced improved data accuracy, shortened timeframes and lowered costs for the industry.

Today, we continue to use the same design that has worked so well for over 20 years. Yet we constantly evaluate, refine and improve the day to day implementation as technology and regulatory issues evolve. Our goal is to remain the industry leader by continually monitoring Sponsor’s needs and developing solutions that are beneficial to their success.

The Biomedical Systems Way

Identical equipment is placed at all sites involved in a study to reduce data discrepancy. Equipment of the same make and model also allows for consistent training across all sites thus shortening the time required by site personnel to learn the equipment and procedures.
A single cardiologist overreader is employed to reduce variability associated with the reading of measurements and interpretations of the diagnostic data.
Global standard operating procedures for our North American and European receiving stations. These Globals SOPs ensures that data collected from anywhere in the world is handled in the same efficient, comprehensive manner and that it meets with Sponsor protocol requirements.

Did You Know Biomedical Systems….

Has participated in studies in over
75 countries around the globe
Offers equipment options for
cardiac safety studies
Employs a multi-lingual staff
that speaks 20 languages
Has Global SOPs to ensure
consistency in data acquisition
and analysis
Offers 12-Lead Holter
Has a dedicated TQT Project Management Team
Places identical equipment in clinical trial sites
Employs a single overreading cardiologist to read per study
Is a certified vendor to the FDA Warehouse and successfully downloaded Sponsor data to the warehouse
Worked with over 11,000 clinical sites around the world

Biomedical Systems’ Chief Scientific Officer, Dr. Tim Callahan will be joining a group of international experts at the 4^th Charles River Labs Symposium in Japan on 24 April 2009. With the theme of the symposium based on recent global regulatory movements and practical approaches to achieve them, Dr. Callahan will give a talk entitled, “Practical Applications of the ICH E-14 Guideline to Thorough and Intensive QT Trials”. The talk will review the historical aspects of the E-14 as well as look at the differences between the “traditional” Thorough QT Study versus the Intensive QT study design required for compounds that cannot be tested using the stricter guidelines.

Dr. Callahan’s talk will also touch on the areas of type of trial (parallel versus crossover), subject population, use of the Positive Control, blinding of the ECGs and the FDA Data Warehouse. For more information on the 4^th Charles River Labs Symposium, please download the PDF brochure.