Innovation In Centralizing Diagnostic Data For Clinical Trials

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 16 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