Newsletter | September 26, 2025

09.26.25 -- The Evolution Of A Clinical Research Coordinator

SPONSOR

Webinar: From Regulation to Innovation: How ICH Oversight Changes and AI Are Shaping the Future of Clinical Trials

Join us to gain insight into the recently released ICH E6 (R3) revisions and their implications for clinical trial oversight. We’ll assess strategies for sponsors to adapt to changing compliance requirements and enhance trial management, and explain how artificial intelligence is transforming clinical trial oversight with predictive insights, automated analytics, and integrated platforms. Click here to register.

TRIAL MONITORING

The Evolution Of A Clinical Research Coordinator

From The Editor | By Dan Schell, chief editor, Clinical Leader

Briana White is a CRC with Superior Clinical Research, a small clinical research site in Smithfield NC. She talks about how she got into the clinical industry and what she struggles with in her job (spoiler alert: it involves tech). 

Automated Trial Monitoring Workflows Make Small Teams More Efficient

Case Study | Medidata, a Dassault Systemes company

A pharmaceutical therapy developer was looking to automate reports, confirmation letters, and follow-up letters. See what happened when they adopted a cloud-based solution for end-to-end trial management.

CLINICAL DATA MANAGEMENT & ANALYTICS

A Real-World ICH E6 R3 Implementation Example

Video | By Clinical Leader Live

Joe Fitzgerald, head of clinical data processing and reporting at Regeneron, provides a concrete example of operationalizing ICH E6 R3's risk proportionate principles using a Phase 3 oncology trial. He walks through the complete framework, making abstract concepts tangible and actionable.

AI In Clinical Trials: Key Insights From Industry Experts

Article | Medable

Find out what experts from the FDA are saying about AI’s ability to demonstrably impact three critical success metrics in clinical trials.

Solutions From Research To Phase IV Studies/Surveillance

Brochure | Verana Health

These integrated data-driven solutions combine secure, advanced AI, deep clinical expertise, and exclusive real-world data from leading medical societies.

Electronic Data Capture (EDC) System: Leverage Flexibility And Speed

Product | Crucial Data Solutions

Neither traditional nor hybrid clinical trials can operate on rigid EDC systems. Give your team the freedom to build, deploy, and manage their studies, their way, weeks faster and for a fraction of the cost.

Solutions For Clinical Data Review

Brochure | Revvity Signals Software, Inc.

This Clinical Data Review solution provides those challenged with analyzing clinical data the ability to quickly spot outliers, dig deep into the data, and take questions to the next step.

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)

Learn more about our personalized newsletters here.

Connect With Clinical Leader: