Electronic Patient Reported Outcomes with an all-inclusive GxP Software Service

Ecoa Introduction

EXECUTIVE SUMMARY

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.


THE CHALLENGE

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 SOLUTION

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 

THE BENEFITS

DATA QUALITY
ensuring the effective central oversight of the Patient's activities related to Drug Compliance and data collection.

PROCESS QUALITY
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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