Clinical research sites are speaking up. The average site now juggles 22 different technology systems per study, each with its own logins, training, and data pipelines. That kind of overload leads to staff burnout, compliance risk, and redundant workflows that drain time and quality. But what if the solution isn’t more technology? What if it’s trusting sites to use the … Read more
In clinical research, budgets are always under pressure. So, when a sponsor, CRO, or vendor offers a “free” system, whether it’s a Clinical Trial Management System (CTMS) or an eRegulatory (eReg) platform (also called an electronic Investigator Site File, or eISF), it can sound like a welcome relief. But as many Academic Medical Centers (AMCs), … Read more
About the Author: Michele Corvino, Vice President of Product at RealTime eClinical Solutions, has more than 25 years of product management experience at companies such as Oracle, IBM Smarter Workforce, and Complion. As VP of Product, she designs and creates innovative solutions that improve clinical research efficiencies and helps customers focus on research and maximizing … Read more
When the FDA announces an audit of your clinical research site, it can feel daunting. However, with proper preparation, your team can confidently navigate the process and demonstrate compliance with regulatory requirements. We’ll unpack essential strategies and practices to help clinical research sites in preparing for an FDA audit, improving the likelihood of a smooth … Read more
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 Outdated systems can lead to slower workflows, limited integration … Read more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
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
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
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
