eReg Resources

1. eISF In European Clinical Trials And How eBinders Can Help 1/18/2024

   By addressing the unique hurdles tied to regulations in European clinical trials, eBinders offer a streamlined approach to managing electronic trial documentation.

2. eReg Benefits For Clinical Research: Use Cases For All Types Of Sites 5/1/2023

   Unearth the different kinds of eRegulatory use cases for diverse clinical site types and other eRegulatory capabilities designed to serve all sites.

3. FDA Guidance Has Implications For EDC And EHR eSource Capabilities 2/28/2023

   Gain insight from an eSource study observing digitally received data as far back as 2007 to just before initial guidance was released by the U.S. FDA in 2013.

4. EU Annex 11: How To Stay Compliant 11/16/2022

   EU Annex 11 lays out the European Union’s regulations for using computerized systems during clinical trials. Learn how sponsors and sites seeking treatment approval in the EU must follow Annex 11. 

5. Utilizing eRegulatory Integrations To Expedite Regulatory Workflows 7/27/2022

   Explore how direct communication and integration between key operating systems contributes to a more efficient and compliant trial. 

6. Beginner’s Guide To eTMF, eISF, And Regulatory Research Documents 7/20/2022

   This blog identifies applicable regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exchange, and store them.