Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging ...

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 ...

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 ...

In this video interview, David Morton, PhD, director of biostatistics at Certara, reflects on the growing role of Bayesian ...

In today's ACT Brief, we explore how Bayesian methods are reshaping FDA interactions and trial design, quality tolerance limits are becoming operational guardrails in risk-based quality management, ...

In today’s ACT Brief, we highlight how Bayesian methods are reshaping adaptive trial design, a major eSource partnership is ...

In today's ACT Brief, we explore the operational capabilities clinical teams need to implement Bayesian trial designs, why gender diversity strengthens data science across drug development, and the ...

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 ...

The Patient Advocate Foundation and the PAN Foundation have announced a strategic merger to create the nation’s most ...

Quality tolerance limits work best as a small set of focused guardrails that prompt rapid investigation and documented action, not as documentation exercises, with early breaches expected when sample ...

As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more ...

Public-private collaboration and structured evidence consolidation are emerging as critical enablers of regulatory-ready digital endpoints, helping standardize terminology, reduce duplication, and ...