BIOPHYTIS, a biotechnology company specialized in the development of drug candidates to treat aging diseases, has announced the implementation of a proprietary e-Health platform, SARA-data, to process patient data from its SARA clinical studies.
By combining highly standardized clinical outcomes with everyday-life health observations, SARA-data platform will allow a comprehensive assessment of the efficacy of Sarconeos in preventing physical disability in sarcopenia.
Biophytis explained that SARA-data is a clinical data platform designed to integrate data from the SARA clinical trials, beginning with the SARA-OBS study, from all sources and in real time. Key elements of SARA-data include:
• Electronic Case Report Form (e-CRF) and electronic Patient-Reported Outcomes (e-PRO), that will be used for more reliable and cheaper data management compared to standard paper-based clinical questionnaires;
• The opportunity for senior patients to utilize a web-based portal to complete standardized e-PROs remotely at home;
• Storage of bio-imaging source data and bioanalytical results, including biomarkers, for secondary research;
• Spontaneous physical activity will be recorded on a continuous basis via a connected accelerometer.
Biophytis selected Bluecompanion and eClinicalHealth, two innovative European e-health-focused firms, as partners for the design and implementation of SARA-data.
Following successful completion of SARA-OBS, SARA-data will also be utilized in the Phase 2b SARA-INT clinical trial, providing a comprehensive system for assessing the effectiveness of Sarconeos, said Biophytis.
Stanislas Veillet, CEO of BIOPHYTIS, declares: “We look forward to leveraging our proprietary e-Health platform, SARA-data, to more accurately track physical activity and analyse other clinical outcomes in sarcopenia patients. I am confident that the use of SARA-data will add significant value to the quality of the clinical data we will generate. Our use of SARA-data represents the exciting convergence of biotechnology and e-Health technology that can make the difference in better understanding sarcopenia in aging patients and better evaluating the effectiveness of Sarconeos.”
He adds: “With Bluecompanion, we have designed SARA-data in order to capture, integrate and make available on the same digital platform different source data: patients’ questionnaires, physical activity sensoring and recording, and DXA imaging, combined to standard clinical data reporting.”
Karl Landert, CEO of eClinicalHealth, comments: “We are pleased to be selected as the Biophytis technology partner to support the implementation of SARA-data. Through the use of Clinpal, we can work collaboratively with Biophytis and Blue Companion to move important innovative research efforts forward in sarcopenia patients.”