News

In today's ACT Brief, we examine a major trial retraction and regulatory action against a rare disease drug, regulatory scenarios for selective safety data collection, and FDA's domestic manufacturing incentive program.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, explains how four jointly developed regulatory scenarios give sponsors a blueprint for adopting selective safety data collection with greater confidence and stronger agency alignment.

Regulators on both sides of the Atlantic have taken action against Tavneos after an FDA investigation found patient outcome data was altered and trial personnel were unblinded during the pivotal study that supported the drug's approval.

In today's ACT Brief, we examine what the FDA's real-time oversight initiative demands of sponsors, why clinical data security must be designed in rather than layered on, and how AI is reshaping CDMO workflows and asset value.

The FDA's launch of real-time clinical trial proof-of-concept studies signals a fundamental shift in regulatory oversight, one that most sponsors are not yet equipped to meet and that demands urgent investment in unified data infrastructure, quality-by-design practices, and protocol digitization.

Clinical data security built into system architecture from the foundation, rather than layered on afterward, reduces regulatory risk and actually accelerates research by removing manual compliance burden and improving team confidence in data integrity.

In today's ACT Brief, we recap key themes from DIA 2026 on operational priorities and regulatory shifts, examine infrastructure gaps in continuous data review, and report on EMA support for a new BTK inhibitor strategy.

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.

In this Q&A, Raj Indupuri, CEO and co-founder of eClinical Solutions, discusses what the FDA's push toward continuous data review actually demands of sponsors operationally, why fragmented systems are the core obstacle, and how AI and real-world evidence fit into a more data-driven regulatory environment.

Discover how Quest Diagnostics puts its vast database of lab results to work and leverages patient and physician credibility to efficiently and effectively connect the best-fit patients to the clinical trials that will benefit from their participation.

Discover how Quest Diagnostics’ comprehensive lab data can elevate your clinical trials. Our latest white paper, "6 Ways Lab Data Can Improve Clinical Trials," explores the power of real-world data at every stage of the trial process.

As the clinical research landscape evolves, decentralized clinical trials (DCTs) have emerged as a foundational competency, enabling broader patient participation, increasing trial efficiency, and driving more inclusive, real-world data collection. However, the successful execution of DCTs requires more than just innovative technology—it demands a comprehensive strategy that addresses the unique challenges of decentralization.

Download the case study and learn how Quest Diagnostics and PatientsLikeMe helped accelerate recruitment and enrollment for a struggling study.

In today's ACT Brief, we examine integrating site and sponsor data systems, a high-profile trial retraction over integrity concerns, and a new first-line breast cancer treatment.

A Phase III trial linking morning administration of immunochemotherapy to dramatically better survival outcomes in non-small cell lung cancer has been pulled over concerns about data integrity, protocol inconsistencies, and unexpected findings.

In this video interview following the 2026 DIA Global Annual Meeting, Jonathan Andrus, co-CEO of CRIO, explains why integrating site-level data systems with sponsor oversight has remained so difficult, what a central eSource model requires to work for all stakeholders, and why the industry needs to stop waiting for perfection and start taking the step.

In today's ACT Brief, we examine regulatory uncertainty and 2026 breakthroughs shaping clinical research, reimagining CRO contracting models for financial transparency, and Eli Lilly's acquisition strategy.

In this video interview, Marwan Fathallah, president and CEO of DIA Global, makes the case for ecosystem-wide leadership in a time of regulatory uncertainty and highlights the breakthroughs in obesity, healthcare AI, and cell and gene therapy that have most excited him in 2026.

Traditional CRO contracting models create misalignment between effort, progress, and financial outcomes, driving revenue recognition risk and margin volatility, but shared performance contracts linking costs to deliverables can improve transparency and accountability.

In today's ACT Brief, we examine HHS coordinated effort to restore US clinical research leadership, two decades of rising protocol complexity, and data architecture frameworks for AI sustainability.

A coordinated department-wide initiative combines FDA regulatory reforms, NIH investments, and new agency programs to reduce development timelines and reverse a growing shift of clinical research overseas.

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.