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
Clinical research is essential for developing life-saving treatments, but for years, trials have often failed to reflect the diversity of the populations they aim to serve. To address this disparity, the FDA introduced the Diversity Action Plan, a significant step toward making clinical trials more inclusive. For clinical research sites, understanding and implementing this plan … Read more
Patient recruitment is one of the most critical and challenging aspects of clinical trials. With up to 80% of trials experiencing delays due to recruitment issues, sites and site networks must adopt strategies and tools to reach, engage, and enroll participants. Purpose-built eClinical solutions are game changers in improving recruitment outcomes. In this guide, we’ll … 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The FDA’s recently released draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” provides critical insights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 clinical research, electronic source (eSource) systems are transforming how data is collected, managed, and utilized. However, as with any technology used in regulated industries, eSource platforms must comply with stringent regulatory requirements to ensure data integrity, security, and traceability. Two primary regulations governing the use of eSource in clinical trials are FDA 21 CFR … 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
2025 is set to bring new advancements in clinical trial site management driven by technology, efficiency demands, and industry growth. Staying ahead of these trends will be key for sites looking to remain competitive. From fully integrated ecosystems to real-time data access, hybrid trial capabilities, and improved participant experiences, here are four key trends for … 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
At the recent Decentralized Trials & Research Alliance (DTRA) conference, industry leaders took to the center stage to discuss one of the most pressing challenges in clinical research: reducing site burden and improving operational efficiency. With the complexity of clinical trials growing exponentially – sites now juggle an average of 22 systems per study – … Read more
