Data Management

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.

Webinar Date/Time: Tue, May 12, 2026 11:00 AM EDT

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.

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.

Pharma modernization initiatives stall not from lack of ambition but from expanding governance layers that distance leadership from execution, slowing decision velocity and delaying the systems integration that drives competitive advantage.

Webinar Date/Time: Thu, May 7, 2026 1:00 PM EDT

Webinar Date/Time: Thursday, April 30th, 2026 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

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, makes the case that intuitive, easy-to-navigate technology directly reduces errors, improves site compliance, and prevents the workarounds that quietly undermine study performance.

As clinical trials grow more complex, the technology infrastructure supporting them is under renewed scrutiny. Across data validation, AI adoption, and site-based systems, 2026 is shaping up as a year of implementation rather than experimentation.

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.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, examines the operational challenges of incorporating wearable data into clinical workflows, including information overload and false alarm fatigue, and what those obstacles mean for patient safety.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, discusses how wearable devices are giving clinicians a unique window into patient health outside the clinic and why that real-world visibility is becoming essential to modern care.

In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, explains how early-stage planning, the estimand framework, and anticipating trial conduct problems can protect data integrity and make results more convincing and actionable.

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.

Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging indicators that arrive too late to prevent these problems instead of measuring readiness during training, when intervention still matters.

In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, examines the most common threats to trial data reliability, including opaque methodologies, synthetic controls, and the limits of AI-driven analysis, while making the case for explainable, transparent trial design.

In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, discusses how increasing trial complexity is making data interpretation less straightforward and why transparency and reproducibility are now essential.

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.