Clinical Trials & Studies
REKA Health is proud to introduce Digital Cardiac Rhythm Monitoring that ensures companies who are engaged in clinical drug trials with regulatory compliance, while protecting patient safety with its digital cardiac rhythm monitoring solutions. Not only are we committed to improving patient safety, we provide solutions for collecting the highest quality ambulatory rhythm electrocardiography (ECG) data in clinical drug trials throughout the pharmaceutical product development lifecycle.
REKA Health specializes in supporting companies' regulatory compliance of patient safety with home and ambulatory electrocardiography (ECG) event monitoring solutions, including medical device, mobile software applications, secured data transmission and cloud data platform. We deliver technology and services that increase the integrity and reliability of home and ambulatory ECG data and improve the efficiency of clinical research. Having integrated technology and reliable processes across our solutions that are built upon proven scientific and regulatory foundation, REKA Health supports pharmaceutical companies, Contract Research Organizations (CROs), Biotechnology companies and Academic Research Organizations to collect and deliver safety and efficacy ECG data critical to every clinical research and pharmaceutical product development.
Our Cardiac Safety consultants have been influential in supporting biopharmaceutical sponsors, medical device companies and CROs to improve clinical trial protocols, increase data accuracy, and mitigate risk. Our industry experts have worked with regulatory authorities for decades, resulting in a thorough understanding of what methodologies and processes should be employed to ensure quality outcomes. As Cardiac Safety is one of the main reasons for drug withdrawals and labeling challenges, you can depend on REKA Health consultants to provide strategic value to your study design, avoid medical and regulatory issues before they become an impediment in the drug development process, all while placing patient safety first and foremost.
REKA Health Cardiac Rhythm Monitoring Solution has consistently demonstrated its key benefits such as high patient adherence (full portability and ease of use), high signal integrity (digital data transmission from device all the way to database, and automated data transfer process eliminates potential human errors), high efficiency (no or minimum skill and assistance required processes), excellent system security (128-bit encryption and HIPAA compliant), data reusability (quality ECG data preserves high reusability) and powerful cloud data processing (streamlining ECG data processing time).
1. REKA E100 was used in a Phase II clinical trial for home cardiac rhythm monitoring in Europe. (See the poster abstract pp20, CP13 DAY-TO-DAY CARDIAC RHYTHM MONITORING BY TRANSTELEPHONIC ECG FOR ANTIARRHYTHMIC DRUG ASSESSMENT: THE RAFFAELLO STUDY EXPERIENCE at the XXVI Congress of the Spanish Society for Clinical Pharmacology, 17-18 October 2013, Cadiz, Spain)
2. Phase II clinical trial RAFFAELLO (RANOLAZINE IN ATRIAL FIBRILLATION FOLLOWING AN ELECTRICAL CARDIOVERSION) was presented at LBCT03 Session: Late-Breaking Clinical Trials III, Heart Rhythm Society's 35th Annual Scientific Sessions, 10 May 2014, San Franciso, USA. (See the abstract, pp3, LB03-04)