eRegulatory

For Academic Medical Centers (AMCs), health systems, and site networks conducting clinical trials, regulatory compliance and document management are pivotal to success. Yet, many institutions are still using legacy eRegulatory/eISF platforms that lack the functionality and efficiency needed to keep up with today’s demanding regulatory expectations. Outdated systems can lead to slower workflows, limited integration … Read more

Academic Medical Centers (AMCs) are among the most prestigious institutions in the world of medicine and research. They are the birthplace of groundbreaking discoveries, home to top-tier investigators, and leaders in medical education and patient care. Their reputation is unmatched in expertise and innovation. But when it comes to clinical trial technology, many AMCs still … Read more

Academic Medical Centers (AMCs) and health systems often rely on Microsoft SharePoint as a document management solution for clinical trials. With its widespread adoption across institutions and integration with existing IT infrastructures, SharePoint may seem like a practical and cost-effective alternative to a purpose-built electronic regulatory (eReg/eISF) system. However, clinical trials operate under rigorous compliance … Read more

In 2025, clinical research will continue to undergo significant transformation driven by key initiatives and updates from regulatory authorities like the FDA and the International Council for Harmonisation (ICH). These updates reflect a broader effort to modernize clinical trial practices, improve patient safety, and ensure that studies remain inclusive, efficient, and aligned with the latest … Read more

The adoption of eReg/eISF solutions in clinical trials can significantly improve outcomes across Academic Medical Centers (AMCs) and health networks, where efficient regulatory documentation management is essential. eReg/eISF solutions, electronic platforms specifically designed for regulatory document and process management in clinical trials, streamline the entire workflow, from document creation and secure storage to real-time access … Read more

eRegulatory, often abbreviated as eReg or eReg/eISF (electronic investigator site file), refers to the use of electronic systems to manage regulatory documentation and compliance processes in clinical trials. eReg is an eClinical solution that streamlines the management of critical clinical trial documents. This safeguards that these important documents are securely stored, tracked, and accessed. Today, … Read more