eReg Resources

1. AI In Regulatory Medical Writing: Balancing Innovation With Human Expertise 12/2/2025

   Artificial intelligence is reshaping regulatory medical writing by accelerating document development while maintaining compliance and scientific rigor, creating faster, regulator-ready submissions without compromising quality.

2. The AI Revolution In Clinical Trials 11/13/2025

   AI is reshaping clinical trials by accelerating patient recruitment, optimizing protocol design, and improving data quality—driving faster, more efficient, and more inclusive research outcomes.

3. How Sponsors Can Drive Success With Central eSource At Investigator Sites 6/17/2025

   Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.

4. Streamlined Site Study Start-Up 3/26/2025

   Explore the critical process of Study Start-Up (SSU) in clinical trials, with an emphasis on the collaborative efforts of sponsors and research sites to enhance efficiency and reduce timelines.

5. Choosing The Right eClinRO Solution For Reliable Trial Data 2/21/2025

   Electronic clinician-reported outcomes (eClinROs) enhance the quality and consistency of clinical trial data. Discover key factors to consider when selecting an eClinRO provider.

6. The Regulatory Binder Checklist For Clinical Trial Sites 7/16/2024

   By following this checklist, research teams can enhance organizational efficiency, maintain compliance with regulatory standards, and confidently navigate the complexities of documentation management.

7. 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.

8. 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.

9. 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.

10. 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.