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.
|Articles|April 8, 2019
Clinerion Partners with Alpha MD to Fast Track Innovative Treatments in India
Advertisement
Clinerion partners with Alpha MD to broaden patient treatment options in India. Patients may be matched with international research studies by bringing Indian healthcare organizations onto the Patient Network Explorer platform. With this partnership, patients will gain better access to clinical care as the Patient Network Explorer draws international clinical studies to the country, directly to the patients who will benefit most from participation in trials.
Read the full release
Advertisement
Related to this article
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.
In this video interview, Claire Riches, VP of clinical solutions at Citeline, makes the case for AI as a sophisticated strategic advisor in trial design while arguing that humans must remain in the lead—especially when factors the model can't fully account for are at stake.
In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.
RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
The Control Plane for Agentic Clinical Operations: Governing Autonomous Digital Actors in Regulated Trials
2
HHS Launches SURPASS Program and Three Complementary Initiatives to Transform Clinical Trial Design and Infrastructure
3
Where AI Leads in Trial Design—and Where Humans Still Need To
4
What an AI-Informed Approach Means for How Sponsors Think About Risk
5