Feature|Articles|June 29, 2026

Real-Time Clinical Trials: What the FDA's Push Toward Continuous Oversight Means for Sponsors

The FDA's launch of real-time clinical trial proof-of-concept studies signals a fundamental shift in regulatory oversight, one that most sponsors are not yet equipped to meet and that demands urgent investment in unified data infrastructure, quality-by-design practices, and protocol digitization.

The FDA's launch of proof-of-concept real-time clinical trials marks one of the most consequential shifts in regulatory oversight in decades. By enabling near real-time visibility into safety signals and endpoint data as trials progress, the agency is pushing the industry toward a continuous development model that most sponsors are not yet operationally equipped to support.

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Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection

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.

October 16th, 2026

Building Trust Into Oncology Real-World Evidence: Q&A with Saamir Pasha and Carole Berini, Ontada

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.

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October 22nd, 2026

Building Standardized Evidence for eSource-Enabled Clinical Trials: Multi-Site Validation of a Clinical Research Coordinator Satisfaction Methodology

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.

October 27th, 2026

Closing the Medical Writing Capacity Gap: Why Training Beats Technology

Medical writing capacity pressure is fundamentally a talent development problem, not a technology problem, since hybrid resourcing and AI cannot substitute for the experienced judgment needed to review AI output and mentor the next generation of writers.

October 21st, 2026

What Expanding AI Ecosystems Mean for Sponsor Complexity and Oversight

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.

October 15th, 2026

Endpoints That Reflect What Patients Actually Value: Who Decides What Counts as Trial Success

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.

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October 26th, 2026

Measuring What Matters: Realigning Clinical Endpoints with Patient Reality

Patients don’t experience primary endpoints, so trials that stop at biomarkers and rigid rating scales risk declaring success while leaving daily burden untouched, and digital tools only deliver meaningful evidence when they are co-designed with patients and deployed with restraint.

October 22nd, 2026

Bipartisan Bill Would Build Reusable Clinical Trial Networks, With a Focus on Rare Disease

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%.