Ambulatory Blood Pressure Monitoring
Medifacts International has over 24 years of experience in providing 24-hour Ambulatory Blood Pressure Monitoring (ABPM). As a result of Medifacts’ efforts over the last decade, ABPM data are now included in most regulatory submissions for anti-hypertensive drugs, serve as a surrogate endpoint to describe the changes in blood pressure over 24 hours (circadian pattern), and are increasingly considered for determining new drug efficacy and safety during regulatory review.
Medifacts maintains the world’s largest database of ABPM profiles and has managed more protocols using this technology than any other company in the world.
Medifacts offers a full range of ABPM services including:
- Design and review of protocols for optimal ABPM data collection
- Case Report Form recommendations for the collection of ABPM data
- Comprehensive, hands-on site training of equipmpment and procedures
- Electronic data transfer
- Site-specific equipment programmed according to study requirements
- Site-driven quality control checks
- Validation of ABPM equipment for use during research trials
- Development of Investigator meeting presentations and support materials
- Preparation of publications for peer-review journal
Medifacts offers a unique and efficient means of standardized ABPM data collection, and we believe it provides added value to the management of ABPM data. We can provide each site with the required study equipment and site-specific software that will enable 24-hour data download and onscreen evaluation at the site. Our standardized equipment increases study data accuracy and timeliness of study execution. The use of this technology has been used to evaluate safety and efficacy of hypertension medications and has also been a valuable tool in determining safety in a number of therapeutic indications.