Andy Studna, Senior Editor

Agency outreach targets a compliance gap affecting thousands of registered trials, with nearly 30% of studies subject to mandatory reporting showing no results submitted to ClinicalTrials.gov.

In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, breaks down how the FDA evaluates substantial evidence of effectiveness for individualized therapies in ultra-rare conditions, and why that determination depends on the totality of mechanistic, biomarker, and clinical outcome data rather than trial numbers alone.

In today's ACT Brief, we examine how protocol interpretation and source document preparation delay study startup, how the plausible mechanism framework accelerates individualized therapy timelines, and how real-time tracking technologies improve supply chain and sample integrity in decentralized trials.

In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, explains how the plausible mechanism framework reshapes the development timeline for individualized therapies by allowing first-in-human studies to serve as pivotal trials and giving sponsors earlier clarity on the evidence needed for approval.

In today's ACT Brief, we examine Thermo Fisher's expanded real-world data access through HealthVerity, how FHIR-based standards are finally enabling scalable eSource implementation, and FDA's second complete response letter for Replimune's oncolytic immunotherapy.

New agreement provides enterprise-level access to claims data covering more than 270 million de-identified patient lives, supporting trial feasibility, recruitment, and real-world evidence generation.

In today's ACT Brief, we explore industry perspectives on operational and methodological shifts defining 2026, how agentic AI will augment clinical trial roles over the next two years, and Roche's expanded partnership with C4 Therapeutics on next-generation antibody conjugates.

In this Q&A, Krishna Cheriath, VP and head of clinical research digital data and AI at Thermo Fisher Scientific, examines how AI is reshaping clinical operations—from case intake and trial design to site burden reduction and the emerging reality of agentic AI in the workforce.

In today's ACT Brief, we examine why expanding governance layers slow digital modernization initiatives, how AI will augment clinical trial roles over the next two years, and how evolving regulatory frameworks are reshaping biopharmaceutical development timelines.

In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, introduces a practical augmentation scale for thinking about how AI agents will transform clinical trial roles over the next two years and why workforce planning for that shift needs to start now.

In today's ACT Brief, we explore why clinical trial diversity requires protocol redesign from the outset, the highest-impact opportunities for AI across the complete trial lifecycle, and the regulatory and operational barriers slowing companion diagnostic adoption in oncology.

In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, maps the highest-impact opportunities for AI across the trial lifecycle—from smarter protocol design and enrollment matching to data collection, cycle time compression, and the emerging potential of synthetic data in rare disease.

In today's ACT Brief, we examine the technical and operational challenges of implementing risk-based monitoring across global trials, how AI must address social determinants of health and site burden, and the emerging role of domain-specific generative AI in clinical practice.

In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, argues that effective patient-centered AI must go beyond direct-to-patient tools to address social determinants of health and reduce the administrative burden on sites so that investigators can focus predominantly on the patient.

In today's ACT Brief, we explore the leadership priorities that enable meaningful AI gains in clinical research, how Bayesian methodologies are reshaping trial design and innovation, and proposed federal budget cuts threatening NIH research funding.

The administration's latest budget proposal seeks sweeping reductions to federal health research funding, including the elimination of several NIH institutes and centers.

In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, outlines the leadership priorities, team structures, and boundary-spanning capabilities that separate organizations that realize meaningful AI gains from those that struggle to move beyond the pilot stage.

In today's ACT Brief, we examine how real-world data is being applied across oncology, ophthalmology, and other therapeutic areas to optimize trial design, how AI is reshaping clinical case intake workflows, and enrollment barriers that led Pfizer and BioNTech to halt a COVID-19 vaccine trial.

In this video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, explains how AI is being applied to case intake today and why successful adoption depends less on technology than on reimagining workflows and investing in workforce upskilling.

In today's ACT Brief, we explore how digital twin technology creates reliable virtual control arms from historical data, what defines an effective clinical trial tech stack in complex studies, and emerging vaccine platforms advancing toward universal influenza protection.

In this Q&A, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, examines what it takes to build and sustain a clinical trial technology infrastructure that can keep pace with increasingly complex study designs.

In today's ACT Brief, we explore how to decide which trial complexities warrant core technology platforms versus custom configurations, how measuring patient and site experiences early identifies actionable solutions, and Daiichi Sankyo's collaboration with Tempus to improve ADC patient selection through AI.

In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, offers a framework for thinking about which emerging trial complexities deserve to be built into core technology platforms and which are better managed as bespoke, one-off configurations.

In today's ACT Brief, we explore how user-friendly technology reduces errors and site workarounds, strategic approaches to combining traditional and real-world data collection for vaccine long-term follow-up, and Merck's collaboration with Infinimmune to accelerate antibody discovery using AI.

In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, makes the case that intuitive, easy-to-navigate technology directly reduces errors, improves site compliance, and prevents the workarounds that quietly undermine study performance.

In today's ACT Brief, we examine the three converging technology priorities reshaping trial execution in 2026, why sponsors must integrate digital and physical supply chains operationally, and Eli Lilly's multi-billion dollar AI drug discovery collaboration with Insilico.

As clinical trials grow more complex, the technology infrastructure supporting them is under renewed scrutiny. Across data validation, AI adoption, and site-based systems, 2026 is shaping up as a year of implementation rather than experimentation.

In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, discusses why sponsors must integrate their digital and physical supply chains as a single operational flow and how to build the in-house capabilities and partner relationships needed to manage that complexity effectively.

In today's ACT Brief, we examine why eClinical platforms must prioritize user workflows over data flow, how digitizing sample tracking prevents integrity failures in transit, and the FDA's consolidated adverse event monitoring system enabling real-time safety signal detection.

In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, examines why current eClinical technology too often prioritizes data flow over the day-to-day needs of users and what a truly guided workflow experience should look like for busy site teams.