Stirling, Scotland - eClinicalHealth Limited, a technology and consulting company dedicated to providing innovative clinical trial solutions, is proud to announce the final results and success of the VERKKO remote online Phase IV clinical trial for diabetes. The objectives of VERKKO, developed in collaboration with Sanofi, Langland and Mendor, were to study the use of a patient-centric online clinical trial platform integrated with Mendor’s 3G-enabled wireless blood glucose meter in a completely remote clinical trial setting. Sixty patients - all recruited through Facebook - participated in the study that had no site visits. Patients self-registered their interest in the Clinpal system, after which the coordinating study site reviewed their application. Patients who were selected reviewed electronic patient information before signing the informed consent form electronically. Study materials were delivered directly to patients who then connected the smart, wireless glucose meter with their personal Clinpal account. Actively guided by the Mendor Smart glucose meter, patients completed an innovative glucose profiling protocol. Their glucose measurements were automatically transmitted from the device into the Clinpal system where they were available for real-time review by the patients and the study site. Various performance indicators were compared with those from a previous study that used a similar study protocol but with a more traditional site-based process. The VERKKO results exceeded expectations in many areas:
Improvements observed in relation to the comparator study:
The approach used in VERKKO is ideal especially for late-phase trials that often involve large patient populations and require a more efficient approach. However, online patient recruitment and engagement can benefit studies of any phase. “We are very pleased with the results that demonstrate that remote trials are not only operationally feasible, but deliver excellent performance and are very well accepted by both the patients as well as the researchers,” said Douglas Bain, eClinicalHealth’s CTO. “We’re looking forward to transforming the clinical trial process and making this technology available to the industry.” Sanofi R&D is contributing to the VERKKO study as part of its innovation program to develop patient-centric clinical trials, to assess the efficiency and perceived value from study participants. For more information, visit
www.clinpal.com
,
www.sanofi.com
,
www.langland.co.uk
and
mendor.com
.
About eClinicalHealth Limited
Headquartered in Scotland, eClinicalHealth Limited, developers of the revolutionary Clinpal patient engagement platform, was founded in early 2012 to provide innovative clinical trial solutions. The company is committed to leading open and collaborative innovation discussions about remote clinical trial processes and technology with pharmaceutical companies, CROs and other service and technology providers.
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