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Articles by Shaun Hastings
10.30.26 -- The New Clinical Trial Regulatory Landscape Balances Speed, Quality, And Compliance — Are You Ready?
Webinar: From Black Box to Trusted Tool: How One Site Verified AI AI can transform clinical research workflows, but in high-stakes environments, trust can’t be automated. Luke Snedaker of West Clinical Research and Mike Wenger of CRIO share what they learned building AI-powered eSource workflows, from early missteps to combining AI with deterministic code and safeguards. Discover a practical framework for deciding where AI belongs and how to use it. Click here to learn more.
10.23.26 -- How One Sponsor Rescued A Trial Mid-Study — Plus 6 Steps To AI-Ready Data
Get Ready For Regulators With This Speed-Quality-Compliance Framework Part two of a two-part series, experts Sapna Rani and Shaun Hastings offer a five-part framework to balance speed, quality, and compliance amid evolving clinical trial regulations. More Than A Copilot: Agentic Clinical Monitoring In Action Clinical monitoring is one of the most resource-intensive and costly parts of a trial, but it’s also one of the biggest opportunities for transformation.
Get Ready For Regulators With This Speed-Quality-Compliance Framework
By Sapna Rani, Lead Analyst, Beroe Inc., and Shaun Hastings, quality assurance professional The regulatory environment — in the EU, UK, and U.S. — regarding clinical trial compliance is changing. In part one, we identified the shift in focus toward risk-based oversight, stronger data governance, and greater acceptance of digital innovation. Now, we focus on what those changes mean in practice.
The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?
By Sapna Rani, Lead Analyst, Beroe Inc, and Shaun Hastings, Quality Assurance Professional Global clinical trial regulators are shifting their focus toward risk-based oversight, stronger data governance, and greater acceptance of digital innovation. ICH E6(R3) is reinforcing this transition through quality by design, proportional oversight, sponsor accountability, and fit-for-purpose technology.
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