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                                                – the use of a direct doctor-patient communication channel through voice assistants and ChatBots
– the management of images and photos taken directly remotely by the patient
– the management of a televisit system that allows the medical staff to interact remotely with the patient
– the integration of clinical data collected in Electronic Health Record (EHR), clinical registries, Lab Database and eCRF systems


The MyHealth platform allows the management of Electronic Patient Report Outcomes (ePRO) via App on smartphones/tablets used by the patient

The automatic randomization tool allows to assign patients in multiple therapy arms defined in the prepared list, distributing the sample based on the stratification variables set and allows to set one or more randomizations of patients in distinct phases of the study, define therapy arms or set double-blind randomization.

The web and mobile platform allows you to monitor in real time the trend of patient enrollment for each clinical trials managed and to view data and statistics of interest relating to the clinical trials, through the graphic display of the data.

My Health eCRF allows to collect and manage informed consent electronically, allowing sending, signing, verification and withdrawal. Electronic informed consent can be administered remotely to the patient via PC, tablet and smartphone, providing better information to patients and enable them to make conscious decisions regarding the participation in the clinical trial through the use of interactive multimedia components.

The system allows the management of high definition images taken and uploaded to the eCRF platform by the medical staff or even directly uploaded by the patient using a tablet, PC or smartphone

Automatic collection of physiological parameters and data of physical activity and rehabilitation carried out by the patient via medical devices, wearable devices and sensors. Through the use of medical devices it is possible to remotely monitor the patient’s parameters (such as Heart Rate, ECG, SpO2, Blood Pressure, Respiratory Rate, Glucose-Related Parameters, Body Temperature).

Management of patient therapy with the possibility of setting various functions and automatic alerts/notifications for the doctor and the patient including:
Pill Reminder,
Drug-drug interaction,
Patient therapy database management,
Blood test results.