October 12, 2007 – ROCKVILLE, MD (USA) / LANGENFELD, GERMANY / SHANGHAI, CHINA, October 12, 2007 – MEDIFACTS INTERNATIONAL, INC. a leading provider of noninvasive cardiac safety services, announces the submission of locked ECG data within 72 hours of last patient visit in an important Thorough QT Study. The innovative design required successive weekly dosing of cohorts to add data until sufficient power was achieved to demonstrate QT safety. This allowed a reduction in overall duration and number of patients shaving time and expense from the study.
Michael Woehler, MEDIFACTS’ President and Chief Executive Officer said: “This innovation was enabled by MEDIFACTS’ unique ability to receive, analyze, process and lock data in real time. Our results were provided in sufficient time to allow for statistical power analysis to be done prior to the induction of the next week’s dosing cohort. Once again, MEDIFACTS’ proprietary WebHeart® platform and leading service capabilities are setting the global standard in cardiac safety data collection, management and submission, and we continue to demonstrate MEDIFACTS’ leadership in Thorough QT Study execution.”
About MEDIFACTS MEDIFACTS is a global leader providing quality Cardiac Safety and Efficacy services to pharmaceutical, biotech and medical device companies that are developing therapeutic drugs and products. MEDIFACTS provides ECG, Holter, and ambulatory blood pressure monitoring services from offices in the US, Europe, and Asia. Driven by best-in-class Science, Technology, and Quality System Management, MEDIFACTS’ Core Lab has been undergoing very strong growth during the last year and the company is now established as one of the top 5 providers in this industry. MEDIFACTS International’s scientific expertise, proprietary WebHeart® technology, global presence and recognized quality leadership mean the company is increasingly selected as the partner of choice by pharmaceutical and biotech drug developers.
WebHeart® is a proprietary, global, Web-based platform that offers a complete solution to acquiring, displaying, measuring, and managing Cardiac Safety data in clinical trials. This system allows for real-time access to ECG and Ambulatory Blood Pressure data. Because no actual programming is needed, the time and cost of both study setup and data submission are dramatically reduced. All ECG data can be converted into an XML format that meets FDA requirements and protocol setups are easily configured and expanded to accommodate additional information.
Contact Jennifer Grigonis Associate Director, Global Business Development Operations MEDIFACTS International 301-424-9700 jgrigonis@medifacts.com www.medifacts.com
