ICH GCP E6(R2) Compliance in Clinical Trials

The ICH GCP E6(R2) guidelines have been amended to encourage implementation of improved approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated.

To help you navigate these standards, we compiled the below information.

We’ve worked with the sponsors, IRBs, and sites to design Florence eHub as an innovative solution simplifying compliance with the updated¬†ICH GCP E6(R2) standards for remote oversight, recording, reporting, electronic records and essential documents.

Florence eHub - Clinical Trial Site Oversight 2

Don’t simply comply with the new ICH GCP E6(R2) guidelines, harness them to accelerate your clinical trials.