In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.
|Articles|November 9, 2009
Vitalograph Successfully Passes MHRA and FDA Audits
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Vitalograph has passed its first routine inspection by The Medicines and Healthcare products Regulatory Agency (MHRA). The Agency reported zero critical findings, zero major findings and few observations. Vitalograph is one of 5% of CROs to pass with this degree of success.
“The results of our MHRA audit in October confirms that our systems and processes...meet the high standards of best practice demanded by this rigorous regulatory environment,” says Vitalograph Clinical Trials Director, Lewis Weidman.
Last year’s FDA audit of the Vitalograph research and manufacturing facility in Ennis, Ireland was also a great success, with zero deficiencies {483's} raised.
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Hierarchical composite endpoints analyzed through pairwise comparisons more accurately reflect multifaceted treatment benefit than time-to-first-event composites, but transparent outcome prioritization, patient involvement in ranking, and reporting of Net Treatment Benefit remain underutilized despite their importance to interpretation.
In this video interview, Claire Riches, VP of clinical solutions at Citeline, offers practical guidance for clinical operations teams beginning their AI journey—making the case that the tools are more accessible than many assume and that waiting to start is a competitive risk in itself.
In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
The new effort combines adaptive platform trial design, AI-enabled site activation, nationwide data infrastructure, and patient data contribution tools to reduce timelines, costs, and patient burden across clinical development.
In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains how AI is shifting trial risk management from reactive to proactive—enabling sponsors to pressure-test protocols and anticipate pivots before a single patient is enrolled.
In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.
AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.
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