DATA RIVER

DataRiver has developed the “My Health eCRF” Web and Mobile Platform (https://www.datariver.health/en/myhealth-ecrf/), 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.