Newsletter | May 2, 2025

05.02.25 -- Sponsor Oversight Strikes Back

SPONSOR

Don’t miss the next Clinical Leader Solutions Expo—an interactive, multi-day event connecting you with top experts and innovative providers. Services Week, May 6–8, will spotlight patient recruitment and engagement, featuring tools and strategies to reach, retain, and support trial participants. We’ll also showcase CROs with oncology expertise, highlighting how they accelerate and streamline studies. Register only for the session(s) that match your interests.

TRIAL MONITORING

Sponsor Oversight Strikes Back: Outsourcing Everything But The Responsibility Under ICH E6 (R3)

Guest Column | By Angus Henderson

If E6 (R3) is ushering in the era of Quality by Design, clinical development consultant Angus Henderson says it's time we talk seriously about oversight by design.

Reimagining Medical Monitoring In Clinical Research

White Paper | Ergomed Clinical Research

Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.

SPONSOR

Webinar: Mastering the Complexities of Gene Therapy Document Writing

Gene therapy is complex—and so is writing about it. From viral vectors to cell types, every element demands deep understanding. Safety reporting adds further complexity: is an adverse event from chemotherapy, a procedure, or the gene therapy itself? These challenges require a thoughtful, flexible approach to document strategy and execution. Explore common hurdles and practical solutions for gene therapy document writing and submissions.

CLINICAL DATA MANAGEMENT & ANALYTICS

Multiple Partnerships Help Drive Precision Medicine Trial For Parkinson's

Guest Column | A conversation with Neuron23's Sam Jackson, MD

Neuron23 CMO Sam Jackson, MD, explains the company’s desire to set a new standard in precision medicine for neurology, backed by well-aligned partnerships and fit-for-purpose digital biomarker solutions. 

The "Five Es" Of Operationalizing AI In Clinical Data Management

e-book | Medidata, a Dassault Systemes company

The “Five Es” framework—Essential, Efficient, Enjoyable, Explainable, and Ethical—offers a comprehensive strategy for operationalizing AI in clinical data management while safeguarding privacy.

End-To-End Data Management Services

Product | Avance Clinical

Avance Clinical’s data management team has gained a world-class reputation for accuracy, precision, and quality of their biostatistics and pharmacokinetic (PK) analysis.

Clinical Analytics Solutions To Unify Your Data

Brochure | Revvity Signals Software, Inc.

Increasingly complex clinical trials require a fast, flexible data and analytics platform. Uncover how access to real-time data is able to drive analytic efficiencies and bring new drugs to market faster.

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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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