Analyzing Start-up Efficiency in Clinical Trials: A Q&A with Barry Lake, Co-founder & President, Devana

Clinical research sites are at a crossroads. The demand for efficiency, transparency, and accountability has never been higher, yet many sites still struggle with fragmented processes, disconnected data, and inefficient workflows. The question isn’t whether data is available but how sites can harness it effectively to improve operations, attract sponsors, and ultimately win more studies … Read more

A Cost-Benefit Analysis of eSource in Clinical Trials

As eSource (electronic source) adoption in clinical trials increases, organizations looking to make the switch are also evaluating the cost-effectiveness and benefits of eSource over traditional data collection methods. eSource enables clinical trial sites to capture, manage, and store data digitally, streamlining workflows and enhancing data accuracy. In contrast, traditional data collection methods, including paper … Read more

Implementing Clinical Research as a Care Option in Academic Medical Centers: A Guide to Leveraging Advanced Business Intelligence Solutions

Explore how academic medical centers (AMCs) can integrate clinical research as a care option (CRAACO) using RealTime-Devana’s advanced software platform. By providing a comprehensive roadmap, this document highlights the benefits of CRAACO, addresses common challenges, and demonstrates how Devana can streamline and improve the process of standing up clinical research programs within AMCs. This guide will … Read more

World-Class Research, Paper-Based Processes? Here’s How to Change That

World-Class Research

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

Everything You Need to Know About the FDA Diversity Action Plan: A Guide for Clinical Research Sites

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

How to Improve Patient Recruitment in Clinical Trials: Tools and Strategies That Work

How to Improve Patient Recruitment in Clinical Trials: Tools and Strategies That Work

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

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