|
Ambulatory Blood Pressure Monitoring |
 |
|
|
Ambulatory Blood Pressure Monitoring
The Global Leader in ABPM
CoreLab Partners is an international provider of 24-hour ambulatory blood pressure monitoring (ABPM) with more than 36 years of cumulative research experience. As a result of CoreLab Partners’ efforts over the last decade, ABPM data are now included in most regulatory submissions for antihypertensive 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.
CoreLab Partners maintains the world’s largest database of ABPM profiles and has managed more protocols using this technology than any other company in the world.
CoreLab Partners has provided ABPM services for clinical studies throughout the world, sponsored by major companies as well as private and governmental organizations. Our ABPM and BP data has been used in NDA submissions and the drug approval process for both efficacy and safety requirements.
Full Range of ABPM Services
CoreLab Partners offers a full range of ABPM services including:
- Design and review of protocols for optimal ABPM data collection
- Case report form (CRF) recommendations for the collection of ABPM data
- Comprehensive, hands-on site training on equipment and procedures
- Electronic data transfer
- Web-based ABPM platform designed for data security, integrity, and ease of integration at the study site
- 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 journals
- Statistical reporting on ABPM data
- WebHeart® ABPM is a 21 CFR part 11 compliant, database-driven system, allowing for expedited set-up and validation
Unique Approach to ABPM
CoreLab Partners offers a unique and efficient means of standardized ABPM data collection, providing 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. 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.
|
|
|