Newsletter | June 20, 2025

06.20.25 -- 5 Ways AI Is Changing Clinical Research — And How

CLINICAL DATA MANAGEMENT & ANALYTICS

Everything To Know About Long-Term Data Collection For Cell And Gene Therapy Trials In The EU

Discover how to secure uninterrupted access to long-term trial data for CAR-T therapies by participating in the European Society for Blood and Marrow Transplantation (EBMT) CAR-T Data Collection Initiative. 

The Crucial Role Of Audit Trail Data In Clinical Research

How can modern clinical trial systems leverage AI-driven audit trail reviews to ensure data authenticity, regulatory alignment, and strategic advantage?

What Do Biostatisticians Think Of The ICH E9(R1) Addendum?

Gain insights from Kristina Bondareva, Head of Biostatistics at OCT Clinical, on the significance of the Addendum and the importance of adopting the estimand framework in clinical trials.

The Future Of AI In Clinical Research, Delivered Today

The FDA's new guidance outlines a future where AI models support regulatory submissions, taking a pivotal step toward modernizing regulatory science.

Accelerating Clinical Data Review With Traceable Workflows

Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

Drug Development Strategy & Analytics

Read how IQVIA Biotech can help develop a strategy that will effectively translate into trial execution and avoid costly amendments down the road.

TRIAL MONITORING

5 Ways AI Is Changing Clinical Research — And How To Embrace It

Discover how AI is transforming clinical trials, learn real tools already in use, and get practical guidance for clinical professionals — especially CRAs and site teams — looking to upskill in an AI-enhanced environment.

Navigating The Maze: Seizure Management And Epilepsy Clinical Trials

Examine challenges and solutions in epilepsy trials, including electronic diaries, placebo response training, and integrated cognitive assessments, transforming research approaches.

The Value Of Continuous Cough Monitoring

This presentation explores how digital health technologies are transforming the way persistent cough is monitored and understood across various respiratory diseases.

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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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