Profil Institute expands capabilities to detect cardiac safety signals in diabetes and obesity clinical trials

Nov 22 2010

Profil™ Institute for Clinical Research, Inc., a company specializing in early phase clinical trials for diabetes and obesity, announced today the expansion of its capabilities for cardiac safety and cardiovascular efficacy studies in the company's early phase diabetes and obesity clinical trials.

"Assessing cardiac safety is a critical early objective for the evaluation of new drugs, particularly in compounds for the treatment of diabetes," said Robert J. Schott, a cardiologist and Director of Cardiometabolic Research at the Profil Institute for Clinical Research.  "At Profil Institute we are excited to be implementing new technologies and procedures which allow us to assess cardiac safety signals in Phase I drug research, specifically in our ability to detect a drug's risk for causing sudden cardiac death with prolongation of the QT interval as a marker.  We understand that detection of cardiac safety signals is mission-critical in early drug development, and new technologies allow us to do this in a more cost-effective and timely manner for our customers."

Profil Institute's cardiovascular research capabilities include automated ECG analysis and Holter monitoring for Thorough QT studies, stress echocardiography and basal and exercise metabolic rate determination.  Through academic partners, Profil Institute is also able to provide magnetic resonance imaging and invasive assessments, including cardiac catheterization and monitoring device implantation.  

As the momentum in performing Thorough QT interval studies has increased, clinical trial companies are racing to adopt the technologies suitable to evaluate cardiac safety. Profil Institute's core expertise in Phase I and II clinical trials and its additional cardiometabolic capabilities enable a timely assessment of cardiovascular side effects within its diabetes and obesity drug studies, as well as the ability to recruit diabetic patients with cardiovascular disease and related metabolic disorders (dyslipidemias).

"When testing a new drug compound, you want a clinical research institute that can assess all possible adverse side-effects early, before the drug enters costly later phase clinical trials," said Dr. Marcus Hompesch, Profil Institute CEO.  "In that respect, early phase clinical trials are certainly the most critical when determining whether or not a new drug will make it to market."

To date, the Profil Institute has been involved with almost every clinically promising drug category and device development in diabetes and in more than 140 clinical studies since the company's inception in 2004. Contributing to Profil Institute's success is that the company is recognized as the leader in automated glucose clamps, considered the "Gold Standard" for the evaluation of anti-diabetic drugs and devices.

SOURCE Profil Institute for Clinical Research, Inc.