An in-depth thought leadership whitepaper explaining how sponsors can operationalize the FDA’s 2025 guidance on inclusive and representative clinical trial design. It outlines current industry ...
In addition to improving payment speed, accuracy, and transparency, modern payment technology is creating new opportunities to further improve the trial experience. For example, AI is being used to ...
This article explores how adopting a “workflow” mindset anchored in measurable sponsor outcomes meets this challenge, ultimately yielding the lower costs, higher quality, and an architecture ready for ...
That's the purpose of the estimand framework—to define ahead of time, before you even start randomizing patients, everything that can happen, and then define the methods you will use to attenuate the ...
At the SCOPE Summit, Tekton Research shares how its physician-led clinical trial network is helping accelerate research in neuroscience and cardiometabolic disease. By pairing pra ...
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 ...
For many years the clinical trial industry has treated older adults as a recruitment challenge, particularly in digital environments. Yet behavioral data from modern recruitment c ...
In today's ACT Brief, we explore the transparency demands of complex trial designs and synthetic controls, how measuring site readiness during training predicts protocol execution, and the FDA's ...
Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging ...
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 ...
ACT Brief: Trial Data Transparency, Protocol Design Drives Enrollment, FDA Shifts Approval Standards
In today's ACT Brief, we examine why transparency in complex trial designs is essential for data confidence, how protocol structure—not operational effort—determines recruitment success, and the FDA's ...
For more than a decade, patient recruitment and retention have been persistent hurdles in clinical research and are consistently cited as the biggest operational challenges with r ...
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