Applied Clinical Trials at the 2026 DIA Global Annual Meeting: Conversations on Data, Outsourcing, and the Patient Voice

Real-time clinical trials require standardized digital data capture at the point of care through scaled eSource-EDC-EHR integration, but progress stalls because competing standards lack regulatory enforcement and one-off system integrations cannot scale beyond single studies without industry-wide alignment and legal clarity on data ownership.

In this Q&A, Saamir Pasha and Carole Berini, PhD, of Ontada discuss what it takes to harmonize fragmented oncology data into reliable real-world evidence, how lab markers can proxy for missing functional status data, and where the biggest remaining barriers to consistent RWE generation lie.

Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.

Clinical trial endpoints define what success looks like, but patients and caregivers are rarely the ones setting that definition, and the gap between what trials measure and what patients actually value is showing up in post-approval evidence, regulatory submissions, and the design rooms where protocols are written.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.

Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, describe what operationalizing regulatory-grade quality frameworks requires—and why fit-for-purpose evidence generation is a transparency and documentation discipline, not just a data cleanliness exercise.

The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.