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

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

How eSource Improves Clinical Trials: 5 Key Benefits

The shift from traditional paper-based methods to electronic source data (eSource) platforms is reshaping data collection and management in clinical trials. In its Draft Electronic Source Data in Clinical Investigations Guidance Document, the FDA has recognized the growing importance of electronic systems in improving data integrity and compliance in clinical investigations. While there is an … Read more

Leading Clinical Trials with Precision: Tracking Performance that Delivers Results

Leading Clinical Trials with Precision

Why Tracking Performance Metrics Matters Academic Medical Centers (AMCs) and health networks, tasked with managing a diverse portfolio of clinical trials, face significant challenges in maintaining operational efficiency, data integrity, and regulatory compliance. One pivotal strategy to navigate this challenging environment is the effective capture and tracking of key performance metrics (KPIs). These clinical trial … Read more