Clinical Operations & Strategy

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Outdated payment methods like prepaid cards and checks create administrative burden and retention friction, but modern flexible payment platforms with multiple payout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%.

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.

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.

Clinical Trials Day is an international celebration of everyone who makes medical discoveries possible. It is also an opportunity to shine a light on the innovations helping to keep research rising.

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.

Managing financial integrity in a complex, milestone-driven operating model.

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.

As imaging-heavy clinical trials grow more complex and globally distributed, sponsors are increasingly re-evaluating traditional infrastructure models, with cloud-native platforms showing potential to reduce operational burden, accelerate site activation, improve imaging quality oversight, and lower total trial costs.

From payment delays and feasibility misalignment to technology burden and AI adoption, clinical research sites are navigating a convergence of pressures that increasingly determine who sponsors work with and how well trials perform.

Zentails announced the first dosage of Azenosertib administered in its phase III Aspenova trial to test azenosertib vs chemotherapy in Cyclin E1-positive platinum-resistant ovarian cancer.

Integrating technology and collaboration to close the evidence gap.

Payment experience—including timeliness, transparency, and consistency—is emerging as a key operational factor influencing site financial stability, working relationships with sponsors and CROs, and overall clinical trial execution.

In this Q&A, Jenna DiRito, PhD, COO and co-founder of Revalia Bio, discusses how earlier, human-relevant data is reshaping go/no-go decision-making in drug development and what a truly front-loaded workflow looks like in practice.