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The FDA’s Draft Guidance for AI in Clinical Trials: Implications for Sites and AMCs

The FDA’s recently released draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” provides critical insights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 Compliance and eSource: A Guide for Clinical Research Sites

Regulatory compliance and esource, a guide for clinical research sites, business professional reading on a tablet

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

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

Clinical Trial Site Management: 4 Key Trends to Watch in 2025

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

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

DTRA 2024 Recap – Reducing Site Burden with Bring Your Own Technology (BYOT)

DTRA 2024 Recap Blog_wp

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

How eSource Reduces Monitoring Costs in Clinical Trials

Electronic Source (eSource) presents a compelling case for reducing monitoring costs in clinical trials. By streamlining data collection, improving accuracy, enabling remote monitoring, strengthening compliance, and altogether reducing administrative burdens, eSource solutions provide a powerful tool for clinical research sites, sponsors, and CROs looking to achieve better outcomes. There’s a reason why thousands of sites … Read more

What is a Site Operations Management System (SOMS)?

What is a site operations management system?

Clinical research is highly competitive and regulated. Staying on top of study oversight and management is crucial for research sites aiming to run efficient, compliant, and impactful trials. But with many moving parts – including study start-up, patient recruitment, compliance tracking, and more – managing numerous trials across multiple locations can become overwhelming. For many … Read more