Newsletter | July 5, 2024

07.05.24 -- Insights Into TMF Challenges & Solutions

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TRIAL MONITORING

Insights Into TMF Challenges And Solutions

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

This is part one of a two-part Q&A I did with Nicole Palmer about a variety of issues surrounding the trial master file (TMF). Here, she talks about the TMF Reference Model, moving to an eISF, and challenges with e-signatures.

GxP Audits Guide For Successful Clinical Trials

Article | By Lella Baker, Advarra

This step-by-step guide helps sponsors and sites prepare for and navigate the various types of audits required at each stage of the clinical trial process.

4 Components To Fulfill Drug Development Goals

Podcast | Halloran Consulting

In this episode, experts share their insights on the four essential components for achieving quality excellence in clinical trials.

PPD™ FSP Solutions, Quality Assurance

Brochure |  PPD™ FSP Solutions

A seasoned QA ally brings extensive local insights and expertise to navigate the intricate web of country-specific regulations.

CLINICAL DATA MANAGEMENT & ANALYTICS

Takeda Chooses Wearable To Improve Patient Experience, Data In Sleep Study

Guest Column | A conversation with Elena Koundourakis, Takeda

Takeda Head of the Orexin Franchise Development and Neuroscience Portfolio Strategy Elena Koundourakis explains why her team decided to pursue the use of DHTs and the benefits of doing so.

The Moral Obligation: Digital Data Capture For Patient-Centric Trials

Article | By Nicole DuPont Latimer, Medrio

Life sciences companies are falling short in aiding patients and study participants. Get an overview of what's required to make the switch to DDC solutions and how it benefits clinical trial participants.

Data-Driven Adaptive Trials Enhance Safety, Progress, And Economics

Article | By Chris Driver, IQVIA Technologies

By offering guidance on optimizing ROI from extensive data collections and various endpoints in clinical studies, learn how IRT technology can enhance the data-driven approach for sponsors.

Clinical Trial Insights: Integrating Direct Data Capture With EDC

Article | Crucial Data Solutions

Discover how researchers can access insights faster and make more informed decisions by capturing data directly from the source.

How FAIR Data Principles Power Clinical Analytics Success

Webinar | Revvity Signals Software, Inc.

Explore key challenges in accessing and preparing analytics-ready clinical data, how FAIR guiding principles can help maximize the value of clinical trial data, and the impact of innovative analytics.

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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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