Advarra electronic data capture (EDC) tool

Manage study data while maintaining 21 CFR Part 11 compliance with Advarra eSource + EDC, an electronic data capture tool.

21 CFR Part 11 compliance

The 21 CFR Part 11 validated system ensures data security and integrity with:

Audit trails
Secure signatures

Unlike REDCap and OnCore’s eCRFs, with Advarra eSource + EDC there is:

No need to keep source documents (paper documents, EPIC, etc.).
No need to ensure the source data is signed/initialed.
No need to notate when you manually enter the data into OnCore.

Comparison: Electronic data capture tools

Electronic data capture tool	Advarra eSource + EDC	REDCap
21 CFR Part 11 compliant	Yes	Partially (only eConsent)
Data export types	Excel, SAS	SPSS, R, Stata, Excel, SAS
Allows data import	No	Yes
Who enters data	Study team	Study team, plus participants can fill out surveys
Allows surveys	No	Yes
Who creates the protocol/project	EDC admin team	Study team

OnCore integration

Advarra eSource + EDC’s integration with OnCore clinical trial management system (CTMS) minimizes duplicate data entry, while maintaining consistent information across systems. This integration streamlines data management for:

Organizations: Pull all organization records from the organization administrator into Advarra eSource + EDC.
Protocols: Import a protocol from OnCore and create a link between OnCore and Advarra eSource + EDC.
Subjects: Subjects in OnCore are automatically created in Advarra eSource + EDC.