In this video interview, Abraham Gutman, founder and CEO of AG Mednet, shares his key takeaways from SCOPE X, including a pointed caution against the idea that agentic AI can run clinical trials autonomously and why process architecture is the real entry point for AI to deliver on its promise.
In this video interview, Abraham Gutman, founder and CEO of AG Mednet, describes how AI can take on rote reasoning tasks like PHI redaction and document QA, and why offloading that work is what gives human experts the clarity to focus on genuine decision making.
In this video interview, Sam Hinsley, statistics manager at Phastar, explains why early phase decisions are the foundation of the entire development pathway and what is at stake statistically when those decisions are made on limited data.
In this video interview, Sam Hinsley, statistics manager at Phastar, introduces the Early Phase ESIG, a new special interest group bringing together statisticians from across academia and industry to share knowledge and raise standards in early phase research.
In this video interview, Sam Hinsley, statistics manager at Phastar, makes the case that as trial designs grow more complex, collaboration between statisticians and clinical experts is not just helpful but necessary to get meaningful answers.
In this video interview, Sam Hinsley, statistics manager at Phastar, explains how statisticians can ensure patient data is used responsibly and innovatively across every phase of development, from rare disease to personalized medicine to AI.
In this video interview, Sam Hinsley, statistics manager at Phastar, reflects on why she chose a career in clinical trials and what it means to do work that she believes makes a genuine difference.
In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen describes how improving representation has changed trial design and site selection at Merck, where the hardest barriers remain, and what the industry will need to sustain meaningful progress over the next five years.
In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen explains how Let's Talk Trials was designed to address gaps in clinical trial awareness and access, what differentiates it from earlier efforts, and how trust sits at the center of the initiative's approach.
In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen discusses how diversity in clinical trials has become embedded in how Merck designs and executes its studies, and what accountability looks like internally across trial planning and community engagement.
In this video interview, Del Smith, PhD, CEO and co-founder of Acclinate, explains how deep community relationships generate insights that improve protocol design, endpoint selection, and site placement, while building an on-ramp that compounds in value across future studies.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, moves past the buzzwords to describe what supply chain resilience means in practice, and why continuity may now deserve to sit above compliance in a sponsor's order of priorities.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, discusses why sponsors must now treat disruption as an expected condition and how real-time visibility and connected systems enable faster, more adaptive responses.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, traces how small documentation errors move through a fragmented supply chain and ultimately erode the trust that patients and regulators depend on.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, examines how siloed data and manual handoffs create version drift, visibility gaps, and failures that go undetected until the operational damage is already done.
In this video interview, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, explains how growing trial complexity has shifted the fundamental supply chain question from efficiency to continuity, and why even small changes can cascade into trial interruptions.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, identifies governance inertia and review cycle lag as the most underappreciated risks when AI speeds up protocol development faster than organizations can act on the insights it generates.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, offers a measured look at where AI is genuinely accelerating upstream protocol work and why proof points of faster approvals reaching patients are still limited.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, makes the case for integrating reimbursement probability into the standard PTRs framework earlier in development, and what happens when sponsors reach approval without a viable value story.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, discusses how crowded pipelines, compressed IP timelines, and competitive differentiation pressures are forcing smaller sponsors to treat protocol design as a core element of business strategy.
In this video interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, explains why the most consequential shift in clinical trial design is not methodological but organizational, and what an analysis of 200 FDA complete response letters reveals about where decisions are going wrong.
In this video interview, Del Smith, PhD, CEO and co-founder of Acclinate, outlines what a practical, sustained community engagement framework looks like in practice and how sponsors can translate that investment into faster, more efficient, and more representative enrollment.
In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, outlines the steps sponsors can take today—from early FDA engagement and robust non-clinical programs to adaptive trial designs and confirmatory evidence packages—to avoid delays as the guidance moves toward finalization.
In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, discusses how heterogeneity in disease course and patient characteristics creates confounding risk when using natural history data as an external control, and what sponsors need to do to achieve meaningful patient matching.
In this video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, examines the biological, dosing, and population-level considerations that sponsors must get right from the start when using basket and other master protocol designs to evaluate individualized therapies across multiple conditions.
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 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 this video compilation, industry experts share their perspectives on the operational, technological, and methodological shifts defining clinical research in 2026.
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 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.
