News

Protocol complexity in clinical trials has risen for two decades, but the trend has not been comprehensively quantified by phase and sponsor across the full 2004–2025 window on ClinicalTrials.gov.

In today's ACT Brief, we examine a major CRO-tech partnership scaling agentic AI, operational challenges sites face with decentralized trials, and AI-driven CNS drug discovery collaboration.

In this video interview from the 2026 DIA Global Annual Meeting, Nick Scott of Biogen and Samantha Hadfield of Thermo Fisher Scientific, discuss where mixed outsourcing models deliver the greatest gains in efficiency and agility, and why a deliberate, partnership-first approach is what separates successful implementations from ones that struggle.

In this video interview from the 2026 DIA Global Annual Meeting, Joan Chambers, independent senior consultant at Tufts CSDD, examines the operational challenges sites face when implementing DCT components and makes the case that the industry is still in a learning phase—one the data will ultimately need to guide.

The enterprise-wide partnership brings Microsoft 365 Copilot, Azure, and Fabric infrastructure to ICON's Orbis platform, supporting AI deployment across study design, site operations, and regulatory workflows.

In today's ACT Brief, we examine mixed FSP models as strategic agility tools, key themes from the 2026 DIA Global Annual Meeting, and federated AI expanding oncology research.

In this video interview from the 2026 DIA Global Annual Meeting, Angie Maurer, VP of AI-enabled clinical development at Medable, describes how digitizing protocols transforms manual amendment workflows into automated, AI-orchestrated processes—and why structured data from the start is the foundation the FDA's continuous review model depends on.

In this video interview from the 2026 DIA Global Annual Meeting, Stacy Hurt, chief patient officer at Parexel, explains how federated AI is expanding what's possible in oncology research, why the patient voice gets lost earliest in development, and why someone in every organization needs to explicitly own patient needs from the very beginning.

In today's ACT Brief, we examine real-time evidence generation priorities, automating protocol digitization, and fit-for-purpose decentralized trial deployment.

In this video interview from the 2026 DIA Global Annual Meeting, Ittai Dayan, co-founder and CEO of Rhino Federated Computing, explains how data fragmentation limits AI in clinical trials, what federated learning can and cannot solve, and what sponsors actually need to deploy these approaches at speed.

Beyond a compliance checkbox, rigorous UAT planning and execution can ensure eCOA platforms function reliably across real-world trial workflows, from study design through post-launch changes.

In this video interview from the 2026 DIA Global Annual Meeting, Nick Scott of Biogen and Samantha Hadfield of Thermo Fisher Scientific, explain why mixed FSP models are becoming a strategic tool for sponsors seeking greater agility and how geography and portfolio structure shape the decision.

In this video interview from the 2026 DIA Global Annual Meeting, Joan Chambers, independent senior consultant at Tufts CSDD, explains how the flexibility and accessibility of decentralized trial modalities are expanding patient reach—and why fit-for-purpose deployment is key to making them work.

A CFO’s perspective on capital allocation, balancing risk and opportunity, and structuring successful China-based clinical programs.

In this video interview from the 2026 DIA Global Annual Meeting, Angie Maurer, VP of AI-enabled clinical development at Medable, explains the three structural barriers that kept protocol digitization out of reach and why the convergence of LLMs, industry standards, and validated environments has finally changed the equation.

In this video interview from the 2026 DIA Global Annual Meeting, Kevin Bugin, head of global regulatory policy and intelligence at Amgen and executive sponsor of TransCelerate's Embedded Pragmatic Trials initiative, reframes the FDA's continuous review expectations around real-time evidence generation and explains why quality by design—not data cleanup—is what regulators are now demanding.

How sponsors can leverage both the EU Clinical Trials Regulation and UK’s reformed framework to achieve cost efficiencies, faster timelines, and stronger regulatory positioning.

In today's ACT Brief, we examine building infrastructure for real-time clinical and real-world data integration, modernizing participant payments to reduce dropout, and a Phase III confirmatory trial failure for a lung cancer drug.

Premium Label & Packaging Solutions launched MyClinicalSuite™, a clinical-dedicated label and packaging environment that segregates trial work from commercial production to accelerate timelines while maintaining regulatory compliance and data integrity.

Outdated payment methods like prepaid cards and checks create administrative burden and retention friction, but modern flexible payment platforms with multiple payout options and global reach can improve participant experience without adding compliance complexity.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, explains why organizations that build infrastructure capable of harmonizing clinical and real-world data in real time will be best positioned for the continuous, data-driven regulatory environment now emerging.

In today's ACT Brief, we examine quantified returns on RBQM implementation, why allowing sponsors to control AI governance builds adoption, and how basket trials reshape rare pediatric oncology development.

A Tufts CSDD study quantifies risk-based quality management's net financial value at $13.8 million per Phase III oncology trial, with ROI multiples up to 22.7x driven primarily by cycle time reductions rather than monitoring cost savings.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, describes how giving sponsors the ability to inject their own SOPs, protocols, and governance frameworks into AI systems is the key to building the trust needed for real-world adoption.

In today's ACT Brief, we examine moving beyond study-level risk management, why execution architecture is essential before AI can deliver value, and growing FDA/EMA support for rare pediatric disease development.

AI can improve recruitment only when it is embedded in protocol design, EHR-enabled matching, patient engagement, site workflow, and governance. The highest-value near-term use cases are human-in-the-loop decision-support applications with documented context of use, validation, privacy controls, and bias monitoring.

In this Q&A, Abraham Gutman, founder and CEO of AG Mednet, discusses why the clinical trial industry has mastered data capture but never built the execution architecture needed to act on it, how the right infrastructure changes the role of human experts, and why enthusiasm for agentic AI is outrunning what clinical trials can realistically support.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, argues that study-by-study RBM is no longer sufficient and describes what enterprise-wide, AI-enabled risk and quality management looks like in practice.