Newsletter | September 12, 2025

09.12.25 -- The Risks Of AI In Clinical Research From A Trial Management Perspective

SPONSOR

Webinar: From Protocol to Execution: Unlock the Future of AI-Powered Clinical Trials

Unlock the future of clinical trials with Medidata’s two-part webinar series. Discover how AI-powered design boosts protocol certainty, accelerates site activation, and ensures enrollment readiness. Then, learn how AI-driven workflows and centralized platforms transform study start-up and execution for unmatched speed, visibility, and efficiency. Don’t miss your chance to revolutionize trial performance and drive success from day one. Click here to learn more.

TRIAL MONITORING

The Risks Of AI In Clinical Research From A Trial Management Perspective

In part two of this series, consultant Donatella Ballerini explores the challenges of integrating AI into eTMF management and how to mitigate them.

Top Technologies Transforming Decentralized Clinical Trials

In today’s clinical development environment, DCT technologies are not optional innovations; they are essential drivers of more resilient, efficient, and patient-focused trials.

Remote Patient Monitoring Using Mobile Health Technology

This study investigates the attitudes of cancer patients towards the adoption of mHealth technologies, including applications and wearable devices, for monitoring purposes during or after their treatment.

SPONSOR

Revolutionize your approach to clinical trials at DPHARM: Disruptive Innovations to Modernize Clinical Research, taking place September 16–17, 2025, in Philadelphia. This conference showcases cutting-edge strategies and technologies designed to reduce patient and site burden, streamline operations, improve data quality, and accelerate access to therapies.

CLINICAL DATA MANAGEMENT & ANALYTICS

Breaking Free from 20 Years of 'Do Everything' Mentality

Joe Fitzgerald of Regeneron provides historical context for the regulatory evolution from ICH E6's original focus on thorough, consistent execution to the current emphasis on QbD. He explains how the industry is shifting from 100% SDV and exhaustive edit checks to early detection and prevention of high-impact errors, emphasizing the mindset change required for successful implementation.

FDA Guidance On The Use Of DMCs In Clinical Trials

Gain an overview of FDA guidance on the use of Data Monitoring Committees (DMCs) in clinical trials and their critical role in safeguarding patient safety and ensuring unbiased decision-making.

Fast-Tracking Regulatory Submissions: How To Cut Review Time By 65%

Discover how leading Biotech teams are eliminating SharePoint headaches, streamlining document reviews, and accelerating submission timelines without the chaos of version confusion or email overload.

The Big Impact Of Medable AI

Streamline your clinical trial study creation by automating and accelerating the eCOA build process. Generative AI models perform your repetitive configurations and significantly shorten build times.

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  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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