Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only ...
The FDA has published a Transparency Roadmap outlining its fiscal year 2026 milestones and fiscal year 2027 priorities across ...
In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread ...
A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight ...
Mixed outsourcing models have moved from exception to mainstream as sponsors look to allocate resources more deliberately, ...
In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical ...
Autonomous capability can expand via new tools, memory, prompts, and delegation despite unchanged models, necessitating ...
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 ...
Community engagement is a powerful tool but its impact depends on how it is done. When it begins early, is sustained over time, and is built through organizations and individuals communities already ...
In a recent video interview with Applied Clinical Trials, Claire Riches, VP of clinical solutions at Citeline, discussed how AI is transforming the way sponsors approach trial des ...
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 ...
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