Medifacts International Inititates TQT Study in 10 Days
Fiona Markwood, MEDIFACTS’ Global Head of Operations said: “Our sponsor wanted to utilize short term availability of a Phase I unit to execute their study. Our ability to rapidly deploy and equip the site, provide on-location training and support; and set up the technology infrastructure necessary to support a substantial Thorough QT Study allowed our sponsor to exploit this opportunity: thereby significantly shortening anticipated timelines and reducing overall study costs.” Michael Woehler, MEDIFACTS' President and Chief Executive Officer added: "Once again, our substantial investments in technology and efficiency in process are benefiting our sponsors. Thanks to MEDIFACTS’ industry-leading service platform and proprietary WebHeart® technology, we have assisted a sponsor in exploiting a tremendous opportunity to save time and cost in their cardiac safety program. MEDIFACTS’ world leading technology and service infrastructure meant we could configure and deploy the project within 10 days of their request. MEDIFACTS and our WebHeart® platform continue to set 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 301-795-2500 jgrigonis@medifacts.com www.medifacts.com