Newsletter | June 13, 2025

06.13.25 -- In The Age Of AI, Data Is Still King

TRIAL MONITORING

From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials

Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

The Difference Between Clinical Trial Auditing And Monitoring

While both trial auditing and trial monitoring have the same goal of protecting participant safety and rights, they are two separate yet important pieces of the clinical trial process.

PPD Monitoring Application (MApp): A Flexible Technical Solution

This dynamic, system-agnostic approach to modernizing clinical trial monitoring supports targeted oversight, as well as sampling at the subject, visit, and form levels.

CLINICAL DATA MANAGEMENT & ANALYTICS

In The Age Of AI, Data Is Still King

While AI captures attention, data quietly runs the show, says Empactful Ventures Founder Denise Bronner, Ph.D. She explains why proprietary data sets are the foundation of everything AI promises to deliver.

Harness AI Beyond Chatbots To Innovate Medical Information Offerings

Take an in-depth look and the challenges and benefits of incorporating AI solutions to enhance Medical Information (MI) services and the necessity of regulatory compliance.

Clinical Analytics Use Cases For AI

Automating FDA data validation rules and analyzing audit trail data can significantly reduce fraud and predict areas of concern. Discover how these advancements can transform your clinical trials.

The Future Of Patient Recruitment: Leveraging RWD For Precision

To combat the costly challenges of patient recruitment and keep trials on track, sponsors can leverage real-world data.

Harnessing Data For Deeper Insights In Medical Information

Discover the groundbreaking software solution that your organization can leverage to meet industry demands by transforming vast amounts of raw data into actionable insights.

AI-Driven Digital Trial Tech Is A "Monumental Breakthrough"

Learn how AI solves repetitive, time-intensive manual tasks to decrease time to First Patient In (FPI) for digital and decentralized clinical trials, dramatically accelerating study startup.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. To make changes to your newsletter selections, update your topic preferences.

  • 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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