|Articles|December 6, 2018

Risk-Based Monitoring in Clinical Trials, 4th Edition

Applied Clinical Trials presents the latest issues that have risen to prominence since RBM adoption grows. This edition presents a well-rounded look at RBM including articles that describe current RBM trends; a survey of European CRAs, which shows the difficulties among sites and monitors with RBM; a comprehensive look at how sponsors and CROs can support their employees in the RBM transition, and closes with a case study on Novartis' use of adaptive monitoring.

External Link - ACT_Risk-Based-Monitoring-Clinical-Trials_2-1-2016.pdf

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

Related to this article

September 18th, 2026

DPHARM 2026: What the Patient-Site Relationship Needs Most Right Now

In a video interview prior to the 2026 DPHARM conference, Andrea Valente, CEO of uMotif, shares what she expects to be at the center of the conversation—from building trust between patients and sites to where AI may and may not have a role in that relationship.

Scaling AI in life sciences takes more than more tools, it takes a platform that connects workflows, data and governance. Credit: Stock.Adobe.com/Grispb.

September 18th, 2026

How a Platform Approach Can Scale AI’s Impact in Life Sciences

A platform-based approach connects AI across workflows, data and governance, helping life sciences organizations move from isolated wins to real scale.

September 18th, 2026

ACT Brief: Patient Voice as Methodology, AI System Bottlenecks, Regulatory Convergence on Patient Input

In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.

© C Davids/peopleimages.com - © C Davids/peopleimages.com - stock.adobe.com

September 17th, 2026

What "Patient Voice" Actually Requires: Beyond the Buzzword

The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.

September 17th, 2026

Lessons from Hundreds of Clinical Trials: AI’s Successes, Gaps, and Opportunities

Why clinical development’s next AI bottleneck is not the model, but the system around it.

September 17th, 2026

ACT Brief: Expedited IND Pilot Launch, Operating Model Importance, and Readiness Prediction

In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.

© JHVEPhoto - © JHVEPhoto - stock.adobe.com

September 16th, 2026

FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines

The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.

© FlowStudio - © FlowStudio - stock.adobe.com

September 16th, 2026

Benchmarking Study Finds Clinical Trial Performance Is Shaped by Operating Model Design, Not Sourcing Strategy

A Syneos Health-announced study from Tufts Center for the Study of Drug Development finds no single sourcing model consistently outperforms others, pointing instead to vendor coordination, governance, and fit-for-purpose design as the real performance drivers.