The Pitfalls of Using SharePoint for Compliance and Document Management in Clinical Trials

The Pitfalls of using SharePoint in clinical trials

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

The FDA’s Draft Guidance for AI in Clinical Trials: Implications for Sites and AMCs

The FDA’s recently released draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” provides critical insights into how artificial intelligence (AI) can be integrated into clinical trials. This guidance is central to understanding the role of AI in clinical research. It marks a significant step toward … Read more

Regulatory Updates in Clinical Trials: What’s New

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

What Sponsors Expect from Clinical Trial Sites: Raising the Bar in 2025

what sponsors expect from clinical trial sites

Sponsors are raising their expectations for clinical research sites to deliver higher levels of efficiency, data integrity, compliance, and patient engagement. With advancements in eClinical technology, increasing regulatory demands, and a growing focus on diversity and hybrid trials, the bar for site performance has never been higher. Several key trends are shaping these expectations. From … Read more

Accelerate Clinical Trial Cycle Times at Academic Medical Centers and Health Networks with eReg/eISF

Accelerate Clinical Trial Cycle Times at Academic Medical Centers and Health Networks with eReg/eISF

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

eReg/eISF in Clinical Trials – 8 Trends Driving Adoption

In our blog, “What is eRegulatory in Clinical Trials,” we explored four key trends fueling the adoption of eReg/eISF across Academic Medical Centers (AMCs), sites, site networks, and sponsors. In this follow-up, we dive deeper, expanding on four additional trends driving eReg/eISF in clinical trials.  The transition from paper-based systems or disconnected platforms to integrated … Read more

What is eRegulatory in Clinical Trials?  

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

Improving Clinical Trial Compliance: Top 5 eRegulatory Features for Academic Medical Centers  

RealTime eClinical Solutions - Improving Clinical Trial Compliance: Top 5 eRegulatory Features for Academic Medical Centers

At the center of every clinical trial lies a maze of regulatory requirements, from FDA regulations to institutional review board (IRB) approvals, and improving compliance in clinical trials remains an imperative. For academic medical centers (AMCs), ensuring compliance with these regulations can be an overwhelming task, often requiring extensive paperwork, meticulous documentation, and stringent adherence … Read more

Clinical Trial Naming Conventions: Refining Standards in Clinical Trial Management 

RealTime eClinical Solutions - Clinical Trial Naming Conventions: Refining Standards in Clinical Trial Management

Clinical trials operate under a strict framework of regulations and compliance standards, reinforcing the importance of meticulous record-keeping. Well-documented cases such as Vioxx serve as reminders for clinical research sites and academic medical centers conducting clinical trials, highlighting the critical nature of maintaining impeccable organization and regulatory adherence. As the volume of data and documents … Read more

The Benefits of eRegulatory for Academic Medical Centers 

The Benefits of eRegulatory for Academic Medical Centers

As of March 2024, there are almost 150,000 clinical studies registered in the United States, with Academic Medical Centers (AMCs) overseeing a staggering volume of clinical trials annually across various therapeutic areas. At the forefront of medical innovation, patient care, and medical education, AMCs drive advancements in healthcare while nurturing the next generation of medical professionals.