Data Management

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.

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.

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.

In this episode of the Applied Clinical Trials Podcast, C.K. Wang, MD, chief medical officer at COTA; and Sujay Jadhav, CEO of Verana Health, discuss how their organizations’ merger is advancing the use of real-world data to inform trial design, patient recruitment, and regulatory decision-making.

As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more flexible, data-driven approaches that integrate prior knowledge, reduce sample size demands, and align with evolving FDA guidance to accelerate evidence generation.

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.

Jonathan Andrus, co-CEO of CRIO, highlights the need for earlier cross-functional collaboration and greater site involvement to ensure data quality, workflow alignment, and operational success.

Jonathan Andrus, co-CEO of CRIO, outlines how disconnected systems and inconsistent data collection across sites create risk, while centralized eSource approaches present a major opportunity.

Jonathan Andrus, co-CEO of CRIO, explains how protocol-driven eSource templates and standardized data capture are improving consistency, oversight, and efficiency across clinical trial sites.

Jonathan Andrus, co-CEO of CRIO, discusses how increased reliance on site-based technologies and eSource is strengthening data quality, compliance, and trust at the point of patient encounter.

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.

Angela Zubel, chief development officer, Debiopharm, emphasizes that organizations willing to standardize data and adopt practical AI tools are already gaining efficiency, cost savings, and stronger real-time oversight across development programs.

Angela Zubel, chief development officer, Debiopharm, outlines how predictive models are improving compound selection from early clinical phases, while noting the ongoing challenges of forecasting success from preclinical development to patient outcomes.

Angela Zubel, chief development officer, Debiopharm, explains how AI-enabled site selection, patient allocation, and real-time data monitoring can reduce costs, shorten timelines, and limit inefficiencies caused by non-performing sites.

As eSource adoption expands, industry leaders are confronting new questions around AI oversight, unstructured data activation, institutional readiness, and regulatory trust. Here’s how experts say the next phase will unfold.

Webinar Date/Time: Tue, Mar 17, 2026 11:00 AM EDT

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.

Mike Wenger, chief innovation officer at CRIO, explains how AI can responsibly support data quality and monitoring with proper oversight, and why advancing eSource and EHR systems remains critical to strengthening data integrity and remote trial operations.

Individual-level attribution modeling reveals that real-world semaglutide effectiveness is not a fixed property of the molecule, but an interaction between pharmacological exposure and modifiable care and support conditions, carrying implications for real-world evidence interpretation and clinical development.

Mike Wenger, chief innovation officer at CRIO, discusses how different site types—from academic medical centers to independent research sites—require distinct eSource approaches, and why aligning technology with site workflows is critical to study execution.

See how real-world evidence is enabling smaller, smarter, and more efficient trial designs through hybrid models, external comparators, and continuous patient monitoring—while preserving the role of traditional clinical trials.

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.