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SOMS

The FDA’s Draft Guidance for AI in Clinical Trials: Implications for Sites and AMCs

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The FDA’s recently released draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” provides critical insights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

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

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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

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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

What is a Site Operations Management System (SOMS)?

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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

Negotiating Sponsor Reimbursement for Site-based Technology​ – A Complete Guide for Clinical Research Sites

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Negotiating Sponsor Reimbursement for site-base technology: A complete guide for clinical research sites

Clinical research is undergoing a significant transformation, driven by the adoption of site-based electronic systems. As the industry shifts towards these advanced digital platforms, including virtual visits, telemedicine, and sophisticated data management systems, their value becomes increasingly evident. eClinical technologies are improving the efficiency of clinical trials and becoming integral to their success. Consequently, a growing … Read more

Data Migration: Getting Started with RealTime  Software Solutions 

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RealTime eClinical Solutions - Data Migration: getting Started with RealTime Software Solutions

Amidst industry movements like the site network consolidation trend, broader diversity in clinical trials, and the increasing complexity of studies, clinical research sites are navigating an environment that demands even greater operational agility. RealTime Software Solutions recognizes this evolving need and offers a comprehensive eClinical suite of solutions designed to improve site operations, streamline workflows, … Read more

Maximizing Budgets in Clinical Trials: The Financial Advantages of an Integrated eClinical Solution  

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RealTime eClinical Solutions - Maximizing Budgets in Clinical Trials: The Financial Advantages of an Integrated eClinical Solution

In an analysis published by Nature, nearly a quarter of all trials experienced setbacks due to strategic issues, commercial barriers, and operational challenges. The financial repercussions of such setbacks are significant, with drug developers facing potential losses ranging from $600,000 to $8 million per day. This statistic underscores the critical importance of effective, end-to-end clinical … Read more

Clinical Trial Site Management: A Complete Checklist for Clinical Research Sites

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Clinical Trial Site Management

Do you have the right site technology to start studies faster, reduce FDA audit risk and lower protocol deviations? Increasingly, clinical research is transitioning from paper-based processes to the adoption of electronic workflows. In fact, since the FDA’s 2003 draft guidance on electronic technology in clinical investigations, the industry has witnessed a surge in the … Read more

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RealTime eClinical Solutions is a leading, enterprise-grade technology provider facilitating global clinical trials with a comprehensive eClinical platform. Purpose-built for clinical research sites, site networks, academic medical centers, sponsors, and CROs, the platform goes beyond traditional CTMS to empower research and business workflows for modern-day clinical trials.

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