CRO/Sponsor

The execution translation gap—the failure to convert identified problems into coordinated, timely action—costs millions per trial through delayed amendments, persistent deviations, and slow site activation, yet remains addressable through aligned accountability and proactive execution management.

A collaborative study by the Tufts Center for the Study of Drug Development and CRIO identifies protocol interpretation and source document preparation as an understudied yet significant bottleneck in study start-up timelines that may hold key opportunities for efficiency gains.

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.

Risk-based monitoring requires integrated data systems, validated analytics, and strong governance to work effectively across global trials, but sponsors face significant technical and operational challenges that demand strategic solutions and organizational alignment.

Real-world data is increasingly used to optimize trial design, reduce recruitment burden, and support regulatory decisions, but adoption remains uneven due to challenges around data quality, integration, and internal alignment across functional areas.

In this Q&A, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, examines what it takes to build and sustain a clinical trial technology infrastructure that can keep pace with increasingly complex study designs.

In this video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, discusses why sponsors must integrate their digital and physical supply chains as a single operational flow and how to build the in-house capabilities and partner relationships needed to manage that complexity effectively.

Sample integrity and traceability often fail not because of science but because clinical trials rely on manual processes and fragmented systems that obscure problems until samples are already compromised.

In the first months of 2026, the FDA has moved on multiple fronts to modernize how drugs are developed, evaluated, and approved, signaling a broader regulatory shift toward flexibility, mechanism-based evidence, and human-centric science.

Why rigorous testing and validation matter more than ever.

Investigator-initiated trials operate under the same regulatory and operational requirements as industry-sponsored studies but rely on fragmented, consumer-grade tools, creating a persistent technology gap that can impact data integrity, efficiency, and compliance.

The next phase of digital transformation in clinical research will not be defined by the number of platforms deployed, but by how well those platforms work together in service of participants, sites, and science.

In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, reflects on the gap between sponsor expectations and statistical reality, drawing on lessons from the COVID era to argue for more pragmatic, cost-efficient trial execution and greater patient access to clinical research.

In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is encouraging sponsors to move beyond traditional methods, leveraging Bayesian frameworks to improve efficiency, particularly in rare disease and small population studies.

As sponsors navigate rising complexity, AI adoption, and global scale, outsourcing strategies are shifting toward hybrid models, deeper CRO collaboration, and function-level flexibility to support execution in 2026.

Sylviane de Viron, data and knowledge manager at CluePoints, shares new data highlighting regional variations in clinical trial risks—and how proactive risk planning based on up-to-date data is needed to overcome them.

Holly Leslie, vice president of services at Ledger Run, discusses how persistent payment friction, increasing administrative burden from AI-generated queries, and lack of sponsor accountability are pushing sites to become more selective—favoring sponsors that pay transparently, reduce operational strain, and treat site experience with the same rigor as patient recruitment.

Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, discusses why suppliers must shift from ESG activity to decision-grade evidence, and how embedding sustainability into clinical research quality could reshape sponsor expectations, oversight, and supplier selection in the years ahead.

Raja Shankar, VP of machine learning at IQVIA, discusses which AI capabilities sponsors are most likely to adopt first to streamline trial workflows and reduce operational burden, while also highlighting emerging applications that could shape the next phase of clinical trial design.

Charlie Paterson, partner at PA Consulting, explains how mixed signals on FDA risk tolerance are accelerating the globalization of clinical trial programs and reshaping how sponsors align development activities worldwide.

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.

Today's biopharmaceutical landscape demands a fundamental rethinking of outsourcing approaches that embrace collaboration, flexibility, and teams willing to meet halfway.