Electronic Patient Reported Outcomes with an all-inclusive GxP Software Service
Ethical eDiary® for Electronic Clinical Outcome Assessment eCOA / ePRO
Using a Cloud Software Services for Electronic Patient Reported Outcome improves the efficiency of the study and the quality of the Patients' data while allowing a reduction in times and costs for completion of a study.
Patient Outcome Data Collection is often implemented as a paper processes whith the Patient Diaries Questionnaires printed and delivered to the Patients and collected by the Investigators.
This way the Patient Outcome Reporting process is time consuming, very difficult to be managed with GxP compliance.
The Ethical eDiary ® Cloud Software Service provides a complete flexible solution to manage the Electronic Clinical Outcome Assessment with:
. a dedicated Mobile App / Device for the Patients;
. a dedicated Mobile App / Device for the Investigators;
. a Dedicated Cloud Database for CRAs, Monitors, Data Managers and Sponsor Staff.
. the Services for Protocol Implementation, Technical Management, Systems Hosting, Documentation, GxP Validation support, Training and HelpDesk.
ensuring the effective central oversight of the Patient's activities related to Drug Compliance and data collection.
exploiting role-based workflows, rules and edit checks to enforce the adherence to Sponsor SOPs and Study Protocol.
TIME & COST SAVINGS FOR THE SPONSOR
delivering a complete, flexible and all-inclusive Software Service with a pre-defined Total Cost of Ownership.
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