Andy Studna, Senior Editor

New FDA-funded resource consolidates regulatory guidance, validation standards, and implementation best practices to help sponsors and developers accelerate adoption of sensor-based digital health technologies in medical product development.

Angela Zubel, chief development officer, Debiopharm, discusses why 2026 marks a shift from AI pilots to broader operational implementation across clinical trials and drug development programs.

In today’s ACT Brief, we explore how eSource adoption is advancing with AI-enabled validation and interoperability, examine how flexible outsourcing models are helping sponsors balance control and efficiency, and highlight why adaptive, simulation-driven trial design is becoming essential to improving study success.

As eSource adoption expands, industry leaders are confronting new questions around AI oversight, unstructured data activation, institutional readiness, and regulatory trust. Here’s how experts say the next phase will unfold.

Miriam Dervan, founder & CEO of mdgroup, discusses how patient-centered strategies rooted in empathy and advocacy engagement can strengthen recruitment, retention, and overall trial execution.

In today’s ACT Brief, we examine new data on regional variation in clinical trial risk, why patient experience must move from intent to execution, and how digital endpoints are advancing efficiency and regulatory alignment in oncology trials.

Jeremy Wyatt, CEO, Ametris, explains how digital endpoints improve trial sensitivity, patient centricity, and efficiency through continuous real-world data, and why early regulatory collaboration is essential to reducing adoption risk and establishing consistent validation standards across programs.

In today’s ACT Brief, we cover a new real-world data collaboration aimed at scalable interoperability, how AI fits into modern data capture and quality oversight, and what leaders say must change to move diversity efforts forward in clinical trials.

Mike Wenger, chief innovation officer at CRIO, explains how AI can responsibly support data quality and monitoring with proper oversight, and why advancing eSource and EHR systems remains critical to strengthening data integrity and remote trial operations.

Strategic collaboration integrates Datavant’s privacy-preserving tokenization technology into Thermo Fisher’s PPD clinical research business to enhance real-world evidence generation, trial enrichment, and patient-level data connectivity.

In today’s ACT Brief, we cover how AI is being deployed to optimize global trial design, why ESG performance is emerging as a core vendor qualification signal, and how sites are becoming more selective as payment practices come under scrutiny.

Holly Leslie, vice president of services at Ledger Run, discusses how persistent payment friction, increasing administrative burden from AI-generated queries, and lack of sponsor accountability are pushing sites to become more selective—favoring sponsors that pay transparently, reduce operational strain, and treat site experience with the same rigor as patient recruitment.

Under a new strategic collaboration, Bristol Myers Squibb will deploy Evinova’s AI-native Study Designer platform to optimize trial design, improve decision-making, and drive efficiencies across its global clinical portfolio.

In today’s ACT Brief, we highlight how purpose-driven efficiency is reshaping clinical development priorities, where leaders see the greatest opportunity for accelerating trial timelines, and how artificial intelligence is already influencing decisions across the R&D lifecycle.

Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, discusses why suppliers must shift from ESG activity to decision-grade evidence, and how embedding sustainability into clinical research quality could reshape sponsor expectations, oversight, and supplier selection in the years ahead.

Raja Shankar, VP of machine learning at IQVIA, discusses which AI capabilities sponsors are most likely to adopt first to streamline trial workflows and reduce operational burden, while also highlighting emerging applications that could shape the next phase of clinical trial design.

Jeremy Wyatt, CEO, Ametris, discusses how operational best practices for integrating wearables into oncology trials center on minimizing patient burden through thoughtful workflow design, careful device selection, and early planning to ensure digital measures fit the realities of complex patient populations.

Charlie Paterson, partner at PA Consulting, explains how mixed signals on FDA risk tolerance are accelerating the globalization of clinical trial programs and reshaping how sponsors align development activities worldwide.

Industry leaders emphasized that accelerating clinical research must go hand in hand with sustained, community-driven strategies to advance diversity, equity, and inclusion in clinical trials.

Miriam Dervan, founder & CEO of mdgroup, explains how treating patient experience as a strategic investment—rather than a secondary consideration—changes how sponsors, sites, and operational teams design and deliver clinical trials.

Mike Wenger, chief innovation officer at CRIO, discusses how different site types—from academic medical centers to independent research sites—require distinct eSource approaches, and why aligning technology with site workflows is critical to study execution.

Industry leaders explore areas of opportunity for acceleration as well as how early-phase planning, technology, and collaboration can keep moving the clinical ecosystem forward.

Ken Getz of Tufts CSDD and Eliav Barr of Merck discuss how efficiency, public trust, and AI all fit into the current state of clinical research.

Holly Leslie, vice president of services at Ledger Run, explains why site selectivity is not yet universal, but increasingly driven by larger, more sophisticated sites that are demanding stronger remuneration policies and greater leverage in sponsor relationships.

Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, discusses how ESG is evolving from a reporting exercise into an auditable measure of operational readiness, and what that shift means for sponsor expectations, vendor qualification, and supplier governance discipline.

Raja Shankar, VP of machine learning at IQVIA, explains how AI-driven trial simulation and automation are beginning to influence decision-making across every phase of clinical development.

Charlie Paterson, partner at PA Consulting, describes how FDA capacity constraints are creating uncertainty from initial submissions through late-stage approval, elongating timelines and influencing global development strategies.

Charlie Paterson, partner at PA Consulting, outlines how limited FDA guidance on innovative designs, decentralized models, and digital endpoints is forcing clinical operations teams to recalibrate expectations and minimize regulatory risk.

New findings from a Phase II study indicate that antenatal treatment with the FcRn blocker nipocalimab resulted in low fetal drug exposure and transient reductions in infant IgG levels at birth, without evidence of impaired immune recovery or vaccine response through nearly two years of follow-up.

Charlie Paterson, partner at PA Consulting, discusses how fewer new guidance updates are pushing sponsors to rely on historical precedents and non-US standards when making trial design and operational decisions.