Editorial Videos

In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, discusses how increasing trial complexity is making data interpretation less straightforward and why transparency and reproducibility are now essential.

In this video interview, David Morton, PhD, director of biostatistics at Certara, reflects on the growing role of Bayesian approaches in modern drug development, emphasizing their potential to improve decision-making, efficiency, and overall trial success.

In this video interview, David Morton, PhD, director of biostatistics at Certara, explores the practical challenges of implementing Bayesian designs, including the need for simulation, cross-functional alignment, and clear communication with regulators.

In this video interview, David Morton, PhD, director of biostatistics at Certara, outlines how increasing FDA support is helping drive adoption of Bayesian methods, particularly in rare disease and small population studies where efficiency is critical.

In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is encouraging sponsors to move beyond traditional methods, leveraging Bayesian frameworks to improve efficiency, particularly in rare disease and small population studies.

In this video interview, David Morton, PhD, director of biostatistics at Certara, discusses how growing FDA support is accelerating the adoption of Bayesian approaches, enabling more flexible, data-driven trial designs through external data borrowing, adaptive decision-making, and simulation-based planning.

Jonathan Andrus, co-CEO of CRIO, discusses how governance across the data lifecycle, site-focused technology adoption, and scalable AI-enabled workflows will define operational readiness in 2026.

Jonathan Andrus, co-CEO of CRIO, highlights the need for earlier cross-functional collaboration and greater site involvement to ensure data quality, workflow alignment, and operational success.

Jonathan Andrus, co-CEO of CRIO, outlines how disconnected systems and inconsistent data collection across sites create risk, while centralized eSource approaches present a major opportunity.

Jonathan Andrus, co-CEO of CRIO, discusses how increased reliance on site-based technologies and eSource is strengthening data quality, compliance, and trust at the point of patient encounter.

Angela Zubel, chief development officer, Debiopharm, emphasizes that organizations willing to standardize data and adopt practical AI tools are already gaining efficiency, cost savings, and stronger real-time oversight across development programs.

Angela Zubel, chief development officer, Debiopharm, outlines how predictive models are improving compound selection from early clinical phases, while noting the ongoing challenges of forecasting success from preclinical development to patient outcomes.

Angela Zubel, chief development officer, Debiopharm, explains how AI-enabled site selection, patient allocation, and real-time data monitoring can reduce costs, shorten timelines, and limit inefficiencies caused by non-performing sites.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Charlie Paterson, partner at PA Consulting, explains how reduced FDA capacity and staff turnover have led to longer regulatory timelines, increased preparation for agency interactions, and delayed feedback during early trial planning.

See how real-world evidence is enabling smaller, smarter, and more efficient trial designs through hybrid models, external comparators, and continuous patient monitoring—while preserving the role of traditional clinical trials.

Assess the data quality, linkage, transparency, and auditability challenges that sponsors must overcome to make de-identified real-world evidence fit for regulatory submissions.