The Vial EDC Platform uses Vial Technology to provide an eSource and EDC in one! Using the guidelines set forth by the FDA for Good Clinical Practice and 21 CFR Part 11 Compliance, Vial has engineered a platform that captures all the data needed in one place. Say goodbye to transcribing data from one platform to another, say hello to a new world of efficiency.

Realtime data capture is saving data to the system as it is collected from the subject during a visit. For example, logging a subject’s Medical History in the EDC as they report it to you is considered realtime data capture.

Audit trails are our best friends. An audit trail helps tell the story of the visit. We will know when data was captured, who captured it, and if/when it was changed for what reason. We didn’t make these rules, we are simply following FDA Compliance Guidelines and Good Clinical Practice!

While the audit trail gives us a a lot of information, we still encourage progress notes in the system for anything that needs a bit more story telling.

It is important to understand that e-Signatures in the Vial EDC are the legally binding equivalent to a handwritten signature. Whenever a user executes an e-Signature in any Computer System, it has the same validity and meaning as their handwritten signature. Electronic signatures are backed by the user's unique credentials used to access the EDC.