Newsletter | July 5, 2024

07.05.24 -- Insights Into TMF Challenges & Solutions


Patient recruitment and retention is a multi-faceted, critical component of clinical trial success. Diversity, timeliness, enrollment, reimbursement, logistics, engagement – where do you start? On August 7th, hear from industry-leading suppliers ready to answer that question – and help solve your specific recruitment and retention challenges. The Clinical Leader Solutions Expo brings you its latest virtual event to help facilitate partnerships that bring life-saving therapies to patients. Register, ask questions, and find your best-fit solution for free.


Insights Into TMF Challenges And Solutions

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

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

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

PPD™ FSP Solutions, Quality Assurance

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


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

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

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

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

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

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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  • 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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