CRO/Sponsor

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

Patient Engagement Strategies in Anti-Obesity Medication Clinical Trials: Addressing Drop Out Rate and Improving Retention

Real-world evidence is shifting from a post-market footnote to a concurrent validation layer running alongside trial data, requiring organizations to build unified data environments that integrate EHRs, claims, and patient-reported outcomes on an ongoing basis rather than retrospectively.

In this Q&A, Del Smith, PhD, CEO and co-founder of Acclinate, discusses how structural and relational barriers continue to limit participation from underrepresented communities in clinical trials—and what it takes to build the kind of trust that translates into lasting research impact.

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.

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.

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.

Clinical development productivity improved in 2025, but gains remain fragile as end-to-end timelines lengthened again, signaling that future success depends less on individual trial execution and more on program-level orchestration, site engagement, and adaptive operating models.

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

FDA Commissioner Marty Makary’s departure caps a turbulent tenure marked by leadership instability, industry pushback, and a series of regulatory controversies that complicated drug development for sponsors and CROs.

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.

Execution instability often originates in strategy timing rather than study conduct, which sponsors can correct by integrating execution oversight expertise earlier in development decisions.

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 Q&A, Hal Green, senior solution architect and life sciences vertical lead EMEA at Loftware, examines how clinical supply chain fragmentation has shifted from an efficiency problem into a resilience problem—and what it takes to build infrastructure capable of absorbing disruption without losing trial continuity.

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 Q&A, Mwango Kashoki, MD, MPH, SVP and global head of regulatory strategy at Parexel, breaks down the FDA's plausible mechanism framework and what it means for sponsors developing individualized therapies in ultra-rare disease settings.

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.

Behavioral science reveals how recruitment failures, site disengagement, and underrepresentation in clinical trials are rooted in early design decisions, and what sponsors can do to address them before they become costly problems.