Featured Editorial
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Human-In-The-Loop In AI Validation And Control: From Principle To Practice
4/28/2026
Explores how human-in-the-loop oversight can move from principle to practice. with a risk-based framework for determining when HITL is required, how the human role should be defined, and what organizational factors influence its effectiveness.
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When The System Breaks, Who Pays? SCRS On Site Tech Gaps
4/27/2026
SCRS CSSO Jimmy Bechtel on why clinical site tech integration is an architecture problem – and who bears the risk when remote systems fail.
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HTA, Digital Twins, And Building Clinical Tech That Lasts
4/24/2026
ISPOR CEO Rob Abbott on HTA-integrated trial design, digital twin evidence gaps, SaMD’s continuous update problem, and the one change he’d mandate for clinical tech.
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Real-World Evidence And Wearables Are Reshaping Trial Tech
4/22/2026
ISPOR’s Rob Abbott on why RWE moved to number two in the 2026-2027 HEOR Trends Report, and what wearables, data fragmentation, and HARPER+ mean for clinical platforms.
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Navigating Elsa's AI Transition: Practical Guidance To Safeguard Confidential Information (Part 3)
4/22/2026
With FDA's Claude-to-Gemini transition underway within Elsa, Kimberly Chew, Esq., and Michael Yang, Esq., offer advice for proactive risk management to safeguard trade secrets and regulatory outcomes in part three of this series on Elsa's AI transition.
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HEOR, AI, And The Future Of Clinical Trial Technology
4/20/2026
ISPOR CEO Rob Abbott on why HEOR must be in the room when clinical trial tech is built, and what ISPOR’s latest Top 10 HEOR Trends Report means for ClinOps.
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AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research
4/16/2026
Companies that successfully use AI are those that understand technology magnifies accountability. Anyone that fails to internalize that lesson could find themselves defending the very systems they relied on to bring those products to market.
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Is It Time To Replace RECIST — Or Just Add AI?
4/16/2026
Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.
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Clinical Research Has System Sprawl Problem
4/15/2026
Disconnected systems are strangling clinical trials. Here’s what’s causing the sprawl, why it keeps getting worse, and what needs to change.
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How Clinical Trial Sites Must Adapt To The Predictive Analytics Era
4/13/2026
Clinical trial sites are now measured, ranked, and selected by predictive models. Learn how to perform and compete in this data-driven new era.