OnlineCRF / Features
Transparency and traceability
The Activity of Doctor's initiation and the progress of CRF can be traced online by Sponsor's CTL profile.
Quick start
Thanks to remote Site initiation, the Project starts quickly.
Decreased couriers, postal and phone expenses
The Project is driven by OnlineCRF, which makes it possible to dramatically reduce costs for Site monitoring and Management.
Decreasing the number of well-qualified staff involved in on-Site monitoring
CRA has its own OnlineCRF profile, which allows being alongside each PMS participant.
High accuracy of data / information
Online validation and tracing of CRF editing enhances the level of data consistency and integrity.
Minimal timelines between all main steps in clinical data management and statistics
Automated system for Data Clarification and export of collected data into convenient format make the final PMS stage short.
OnlineCRF is compliant to 21 CFR, Part 11 Guidelines:
- Secure Individual Authorization
- Limitation of inactive session
- Logging of wide range of users' actions and activities
- Data validation prior to saving
- Tracking CRF changes and providing reasons for CRF alterations