Clinical Operations & Strategy

In this pilot episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Paulo Limgenco, VP of business operations and ESG strategy lead at YPrime, about how sustainability is shifting from a compliance checkbox to a factor that shapes vendor selection, client trust, and long-term business value.

Clinical development operates as an integrated system where dependencies persist across phases and vendors, but treating contracts as execution handoffs creates invisible oversight gaps that surface later as vendor performance problems, timeline slips, or inspection findings.

In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explains why execution failures surface where they're visible but originate where conditions were set—and why clinical operations leaders too often inherit problems they had no hand in creating.

Clinical R&D modernization stalls through incremental optimization of individual workflows, but meaningful systemic change requires leaders to visualize structural relationships, understand hidden incentives, and identify leverage points that benefit the whole system rather than parts.

The evolving role of medical affairs in connecting patients, physicians, and evidence generation.

Protocol assumptions about patients, visit schedules, timelines, and vendors are rarely tested against operational reality until startup, but early engagement of experienced execution strategists can identify and mitigate feasibility gaps before commitments harden into expensive course corrections.

From real-time evidence generation to federated AI to site-level data integration, ACT spoke with seven experts at DIA 2026 on the trends and challenges defining clinical trial operations today.

Discover how Quest Diagnostics puts its vast database of lab results to work and leverages patient and physician credibility to efficiently and effectively connect the best-fit patients to the clinical trials that will benefit from their participation.

Discover how Quest Diagnostics’ comprehensive lab data can elevate your clinical trials. Our latest white paper, "6 Ways Lab Data Can Improve Clinical Trials," explores the power of real-world data at every stage of the trial process.

Download the case study and learn how Quest Diagnostics and PatientsLikeMe helped accelerate recruitment and enrollment for a struggling study.

Traditional CRO contracting models create misalignment between effort, progress, and financial outcomes, driving revenue recognition risk and margin volatility, but shared performance contracts linking costs to deliverables can improve transparency and accountability.

Outdated payment methods like prepaid cards and checks create administrative burden and retention friction, but modern flexible payment platforms with multiple payout options and global reach can improve participant experience without adding compliance complexity.

In this Q&A, Abraham Gutman, founder and CEO of AG Mednet, discusses why the clinical trial industry has mastered data capture but never built the execution architecture needed to act on it, how the right infrastructure changes the role of human experts, and why enthusiasm for agentic AI is outrunning what clinical trials can realistically support.

In this Q&A, Robert Hummel, chief operating officer at Suvoda, discusses how agentic AI is compressing RTSM build and deployment timelines, what safeguards are needed to maintain compliance and oversight at speed, and how intelligent automation will reshape the broader clinical trial technology stack over the next decade.

From planning one Phase III trial at a time to digital standardization on repeat.

In this Q&A, Sam Hinsley, statistics manager at Phastar, discusses the role statisticians play in raising standards across the clinical development timeline—and why getting early phase decisions right is critical to the entire drug development pathway.

Optimization challenges spurring cultural, strategic, and organizational change.

Study coordinators identify only about 45% of critical and major problems during document reviews, with substantial performance variability across experience levels, but focused training can improve detection rates from 45% to approximately 68%.

Despite political headwinds, life sciences leaders are holding their ground on DEI, but translating organizational commitment into representative enrollment requires structural changes to protocol design, site selection, and community engagement that most of the industry has yet to fully make.

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 Q&A, Adrelia Allen, executive director of clinical trial patient diversity at Merck, discusses how the company is embedding diversity into clinical trial execution—from protocol design and site selection to long-term community engagement that extends well beyond individual trial timelines.

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.

The CNPV program has compressed drug review timelines to as little as one to two months for qualifying sponsors, but succeeding under that pressure requires a fundamental rethink of how development teams plan, communicate, and execute.