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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.

When a single pivotal trial can determine the fate of an entire program, success depends less on marginal gains in speed or cost and more on building robust, adaptive trial designs that actively manage uncertainty and protect the probability of a positive outcome.

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.