Rapidly evolving research and regulatory markets are focused on blood pressure (BP) from both an efficacy and a safety endpoint.
Bioclinica is an international service provider of BP solutions, including Ambulatory Blood Pressure Monitoring, 24 hour pulse wave assessment and automated home and office BP solutions to fit the specific needs of a clinical trial design. Both the home and office BP monitoring include remote data telemonitoring either directly from the patient’s home or clinic to a centralized study data base. Bioclinica can support a series of options to meet the needs of a study from early clinical development through late stage clinical trials and provide a quality BP monitoring solution for you.
Ambulatory blood pressure monitoring (ABPM) – from efficacy to safety
Bioclinica began integrating ABPM technology and services within the anti-hypertensive research indication over 25 years ago. Besides being actively used and regarded as a key diagnostic technology within hypertension research, ABPM data are now included in a number of regulatory submissions for novel drugs, serve as a surrogate endpoint to describe the changes in BP over 24 hour time periods (circadian patterns), and are increasingly considered for determining new drug safety during regulatory review.
Bioclinica’s full range of ABPM services include:
- Design and review of protocols for optimal ABPM data collection
- Case report form (CRF) recommendations
- Study equipment, validation and hands-on site training
- Web-based ABPM platform optimized for standardized data collection, security and study site integration
- Real-time, onsite, quality control checks
- Flexibility with ABPM technology to meet the study requirements, therapeutic indication and population
- Cardiac safety BP threshold notification based on study criteria
- Advanced statistical reporting on ABPM data
As leaders in the conduct of trials with BP endpoints, Bioclinica maintains a leadership role in shaping regulatory trends through active participation with the Metrics Champions Consortium (MCC) and the Cardiac Safety Research Consortium (CSRC). With unparalleled experience in the management of protocols using ABPM technology, Bioclinica has provided comprehensive ABPM services for pharmaceutical, biotech, and government sponsors. Our ABPM and BP data have been used in NDA submissions as part of the drug approval process. Bioclinica is an international provider of ABPM with more than 36 years of cumulative research experience. We have supported >300 protocols and 300,000 ABPM records across the globe.
Automated Blood Pressure
Automated blood pressure (BP) measurement is increasingly viewed as a preferred alternative to traditional methods of BP measurement in clinical trials. Bioclinica has proven experience integrating automated BP in clinical trials for both office and home environments.
Benefits of Automated office BP monitoring:
- calibration and standardization of equipment across study sites
- removal of variability resulting from human/auscultatory bias
Benefits of Automated home BP monitoring:
- Capture of BP data in a comfortable environment
- Elimination of the white-coat effect
- Elimination of transcription errors (when implemented as a remote telemedicine solution)
- Early identification of trends in BP responses
- Early endpoint identification (adaptive clinical trial design)
RESOUCES FROM TRUSTED
WebHeart® Overview Sheet
Bioclinica’s comprehensive cardiovascular safety services are built on WebHeart our proprietary trial management platform. From Phase I studies to global, large multisite studies, WebHeart provides sponsors with a configurable and validated tool for the capture, processing, analysis, reporting and archiving of cardiac safety data.
Collection and Analysis of BP Data for Clinical Trials
Assessment of drug-induced increases in blood pressure during drug development: Report from the Cardiac Safety Research Consortium