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. Key Changes For Computerized Systems And Electronic Data 5/24/2023

    Explore several modifications introduced in the updated guidelines by the European Medicines Agency regarding computerized systems and electronic data in clinical trials.

  3. 6 Ways Sponsors & CROs Are Optimizing Site Performance 5/11/2023

    See how Florence’s Site Enablement Platform works to overcome common trial hurdles and improve clinical trial operations, accelerate studies, and streamline compliance.

  4. 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.

  5. 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.

  6. 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. 

  7. Inova Health System Uses Advarra eReg Workflows And Integrations To Improve Regulatory Efficiency 2/22/2021

    Maintaining efficient, effective regulatory management processes can be a significant challenge. At Inova Health System, the research team improved regulatory efficiency by 20% without the need for extra regulatory staff by adopting Advarra’s eRegulatory Management System.