• If We Were Designing Clinical Research Today, Would We Still Separate Source Documentation from Data Capture?

    Clinical Research News | Clinical research has never been only about generating evidence that a therapy is safe or effective. It is equally about generating confidence in the evidence itself. Every observation, every assessment, every protocol deviation, every adverse event, every laboratory result, and every conclusion must be supported by documentation that can withstand scrutiny. We work in a profession built on verification. “Trust but verify” is woven into our quality systems. “If it wasn't documented, it wasn't done” is probably the most recognized sentence in our field.

    Sep 16, 2026

  • The Adherence Imperative: Clinical Operations and Patient Centricity

    Clinical Research News | Participant adherence is a leading indicator of trial health. Adherence reflects patient centricity as a measure of how effectively a clinical trial has removed barriers, supported participants throughout the study journey and enabled sites to deliver a high-quality participant experience. As participant experiences improve, usually so does adherence, especially considering that approximately half of all dropouts in phases 2-3 come down to participant choice rather than adverse reactions or study staff decisions.

    Sep 11, 2026

  • Global Effort to Overhaul Regulatory Framework for AI Medical Devices

    Clinical Research News | Data routinely captured to track health and measure wellness do not reflect ground truth, as is well known in the field of medical informatics. That imperfect healthcare data is nonetheless being used to train artificial intelligence (AI) models powering devices used in patient care, often having never been evaluated on their clinical effectiveness.

    Sep 8, 2026

  • The Scope of Things: Source Preparation Emerges as a Clinical Trial Startup Bottleneck

    Clinical Research News | Clinical trial startup delays are often attributed to budgets, contracts, and regulatory review, but a less visible bottleneck may occur at the investigative site level: source preparation. During the latest episode of The Scope of Things, Ken Getz, executive director of the Tufts Center for the Study of Drug Development, and Rick Ward, chief commercial officer at CRIO, discussed their companies’ collaboration exploring how preparing source documents delays getting the first patient in and slows enrollment.

    Sep 3, 2026

  • FDA's Real-Time Clinical Trials Initiative Takes Shape: What Near-Live Data Sharing Means for Sponsors and Operations

    Clinical Research News | The FDA's Real-Time Clinical Trials (RTCT) initiative is testing whether earlier access to selected clinical trial data can improve regulatory oversight by allowing reviewers to observe selected safety and efficacy signals while studies remain underway. Under the proof-of-concept pilot announced in April, participating sponsors share agreed-upon data elements rather than giving FDA reviewers unrestricted access to complete trial databases.

    Sep 1, 2026