MORE THAN AN eCRF
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
Features
The My Health eCRF Platform allows the management of Phase I – IV and observational clinical trials on drugs and clinical trials on medical devices
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
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