Clinical Operations & Strategy

In this first part of a 2-part perspective, clinical trial recruitment failures are reframed as design outcomes, making the case for embedding enrollment feasibility into protocol governance from the start.

Closing the gender gap in data science and tech requires tackling barriers at every stage, from early education through career advancement, while actively challenging the unconscious biases that continue to hold women back.

Webinar Date/Time: Thursday, March 26th, 2026 at 12pm EDT | 9am PDT | 4pm GMT | 5pm CET

Jonathan Andrus, co-CEO of CRIO, discusses how governance across the data lifecycle, site-focused technology adoption, and scalable AI-enabled workflows will define operational readiness in 2026.

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.

Rising development costs, low success rates, and increasing trial complexity are reshaping the clinical trial project manager role, demanding stronger digital fluency, adaptive leadership, and expanded stakeholder coordination to deliver studies efficiently.

Webinar Date/Time: Thursday, March 12th, 2026 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET

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.

Explore how AI, decentralized tools, eSource, and IRT are reshaping clinical development operations in Applied Clinical Trials' February issue.

Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, discusses how ESG is evolving from a reporting exercise into an auditable measure of operational readiness, and what that shift means for sponsor expectations, vendor qualification, and supplier governance discipline.

Charlie Paterson, partner at PA Consulting, outlines how limited FDA guidance on innovative designs, decentralized models, and digital endpoints is forcing clinical operations teams to recalibrate expectations and minimize regulatory risk.

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.

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

Acknowledging the need to optimize decentralized adoption of innovation in clinical research.

Examine how the FDA’s acceptance of de-identified real-world evidence shifts clinical operations workflows and why understanding the difference between pseudonymized and anonymized data is now critical for privacy, compliance, and evidence generation.

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.

The clinical trial ecosystem is entering a phase of consolidation and reinvention driven by the collapse of boundaries between functions, data, and even companies themselves.

Persistent recruitment delays, high dropout rates, and missed timelines continue to slow global clinical trials, while data show that sub-Saharan Africa offers a largely untapped opportunity with established research capacity, large patient pools, and strong enrollment and retention performance.

Review the performance, engagement, and satisfaction metrics sponsors and CROs should track to determine whether operational improvements are reducing burden and strengthening site relationships.

Learn how AI-enabled automation can streamline existing operational processes, reduce manual effort, and enhance efficiency while allowing sites to work as they do today.

Webinar Date/Time: Tuesday, January 27th, 2026 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Examine how evolving sourcing strategies, functional standardization, and system choices can help sponsors support sites more effectively while minimizing operational switching and complexity.