CRO/Sponsor

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.

Moving beyond vendor evaluation to incentive design in Phase II/III rare and genetic disease trials.

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.

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.

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.

As trials expand into new geographies and decentralized models mature, sponsors are confronting a core operational challenge in 2026: how to scale global execution while reducing system complexity and day-to-day burden on research sites.

As ESG expectations rise across clinical development, sponsors are finding that sustainability efforts gain traction only when embedded into existing vendor oversight and quality management processes rather than treated as a standalone reporting exercise.

Assess the data quality, linkage, transparency, and auditability challenges that sponsors must overcome to make de-identified real-world evidence fit for regulatory submissions.

A look at how efficiency, access, platformization, AI, non-traditional players, and regulatory recovery are expected to reshape clinical operations in 2026.

Global clinical development has evolved into a technology-enabled, highly regulated, and geographically diversified enterprise, as sponsors adapt trial design, partnerships, and operations to meet rising demands for scale, speed, and patient-centricity.