Newsletter | September 25, 2025

09.25.25 -- 3 FDA Guidance Documents That Shaped Today's Computer System Validation

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FEATURED EDITORIAL

3 FDA Guidance Documents That Shaped Today's Computer System Validation

Consultant Richie Siconolfi outlines three FDA guidance documents for evaluating and mitigating risks in validating computerized systems.

INDUSTRY INSIGHTS

How Can Sponsors Enable Research-Naïve Clinical Trial Sites

Clinical trial capacity in the U.S. is heavily concentrated, and technology is playing a critical role in enabling a shift to expanding site networks and alleviating the burden on sites and patients.

Enhancing The Accessibility And Affordability Of Healthcare

The March/April 2025 issue of Value & Outcomes Spotlight explores the urgent global health crisis of accessibility and affordability, highlighting the nearly 2 billion individuals lacking essential medicines.

How RFI/RFP Optimization Changes The Game

Selecting the right vendors can determine whether a clinical trial advances smoothly or stalls under budget overruns and delays.

Optimizing Site Activation To Accelerate Clinical Trials

Clinical trial site activation delays are a major bottleneck in drug development, hampering trial timelines and funding flows. To reverse this trend, site-focused solutions are being prioritized.

Mental Health Apps: Regulation And Validation Are Needed

Explore a proposed digital ecosystem that would balance rigorous validation with the urgent need for accessible mental health solutions, transforming the landscape into a resource for global well-being.

Building One Home for Sites

Watch this presentation and demonstration of One Home for Sites for the latest updates on how the industry is coming together — even competitors — to alleviate the technology burden on research sites.

The FDA's Remote Regulatory Assessments: The Future Of Inspections

Remote Regulatory Assessments (RRAs) provide distinct advantages over traditional inspections, such as increased efficiency, reduced travel costs, and enhanced global oversight capabilities.

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