DATARIVER SRL

DataRiver has developed the “ARIA” Telemedicine Platform, certified as a class IIa medical device according to MDR 2017/45, designed to ensure effective interaction between medical staff and patients and offer a tool for monitoring patients’ health and quality of life.

The ARIA platform enables:

– remote monitoring of the patient’s physiological parameters through the use of medical devices

– the management of Patient Report Outcomes (ePRO) for the administration of patient questionnaires via smartphone

– the management of a video-visit system that allows physicians and nurses to interact remotely with the patient

– the receipt of pre-alerts in case the values monitored by the patient through the medical devices used and the scores of the electronic questionnaires, exceed a certain threshold or a range of values predefined by the clinician

DataRiver has developed the “My Health eCRF” Web and Mobile Platform, for the management of clinical trials of Phase I – IV drugs, observational studies and trials on medical devices.
The My Health platform is validated (Computer System Validation) according to international standards and guidelines for clinical trials: ICH GCP, 21 CFR part 11 and IT security: OSSTMM, OWASP, NIST 800-115, ISO-IEC 27: 000 2016, ISO / IEC 27001: 2017, ISO / IEC 27002: 2013.

My Health eCRF allows to have a unified and complete view of information relating to patients enrolled in clinical trials, integrating the data collected through:

– a validated eCRF system for the management of Phase I – IV and observational clinical trials on drugs and clinical trials on medical devices
– app for administering patient questionnaires via smartphone and tablet
– wearable devices and sensors worn by patients to collect data on physical activity and rehabilitation performed
– medical devices for the collection of physiological parameters

MyHealth eCRF allows to optimize and reduce the workload of clinical centers during the course of the clinical trials through the use of several digital tools including an electronic informed consent management system and an eTMF system.