
Edios eInformedConsent
Edios eInformedConsent Solution is changing the way sites work with patients by transforming an inefficient process, supporting regulatory and protocol compliance, and improving patient comprehension, satisfaction and retention. Edios eInformedConsent Solution makes the informed consenting process more efficient and effective for patients, sponsors, sites and monitors. Elegantly designed to focus attention with documents that are easy for all patients to read, the fully-validated eInformedConsent solution uses explanatory videos, audio narration and glossary terms to put “informed” back into informed patient consent.
Edios eInformedConsent Key Features
Ensure patient understanding with engaging multimedia education
Enable real-time remote monitoring and tracking into the global consent process
Provide unprecedented insight into how patients read and understand documents
Improve patient retention through increased comprehension and satisfaction
Comply with global requirements (e.g. 21 CFR-Part 11, Annex 11, EU regulations)
Eliminate common paper errors (e.g. wrong versions, bad signatures) with secure document management
Patients
View multimedia education with consistent ICF term explanations
Better understand the risks and benefits of trial participation
Online Help with Frequently Asked Questions & Answers
Site Staff
No longer manage different versions of paper documents
Include all site specific variables in the documents
Receive alerts and track if/when subjects need to re-consent
Monitors
Check on a site consent status conveniently and remotely
See only the information they have authority to view
Have confidence that dates/times are always correct
Sponsors
Rest assured of the integrity of the consent process
Access useful analytics to track progress and identify trends
Achieve better recruitment and retention rates
Problem Solved
Inconsistent messaging
Challenging language(s)
No Transparency/Accountability
Lack of auditable controls
Lack of auditable controls
Frequent regulatory failures
Version Management/Control
Time-consuming and error-prone paper-based logistics