October 26, 2007 – ROCKVILLE, MD (USA) / LANGENFELD, GERMANY / SHANGHAI, CHINA, October 26, 2007 – MEDIFACTS INTERNATIONAL, INC. a leading provider of noninvasive cardiac safety services, announces the signature of a 4-year study worth in excess of $4.2 million dollars. The award – by a major West Coast biotechnology company - represents a substantial 15 month Phase III study with extension work stretching over nearly 3 years.
MEDIFACTS will provide comprehensive global cardiac safety and efficacy services including provision of equipment for digital collection and centralization of data that will be transferred to MEDIFACTS for processing and analysis. MEDIFACTS’ proprietary web-based platform, WebHeart® will enable the efficient management of the data, and provides a fully-digital environment for manual measurement and overread of ECGs and other cardiac safety and efficacy data while exceeding regulatory guidance and technical standards.
Michael Woehler, MEDIFACTS’ President and Chief Executive Officer said: “We are delighted to be supporting this important study, a key program for our sponsor exploring a substantial therapeutic advance. This award represents repeat business and as such is another endorsement of the tremendous quality of MEDIFACTS’ global services and a continuing vote of long term confidence in the Company by the sponsor community. MEDIFACTS and our WebHeart® platform continue to set the global standard in cardiac safety data collection, management and submission, and we continue to consolidate our position as one of the top 5 global cardiac safety businesses.”
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 three years 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
