Newsletter | July 12, 2024

07.12.24 -- Insights Into TMF Challenges And Solutions — Part 2

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Right-sized for biotech success

It’s not the size of your company. It’s the size of your passion and your dedication to improving patients’ lives that IQVIA Biotech is uniquely built to serve. There is nothing bigger to us than your success. We’ve got you.

CLINICAL DATA MANAGEMENT

Defining Critical Elements For TMF Quality In ICH E6(R3)

By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).

Questions To Ask Before Implementing Data Standards In Science

Discover how to assess your current data management practices, identify the standards that best align with your needs, and develop a strategy for successful implementation.

Leveraging Large Language Models For Business Automation

Unlocking the full potential of Large Language Models (LLMs) for operational workflows requires strategic selection and meaningful prompts. Let’s explore their application in business automation.

Utilizing Multiple Data Sources For Comprehensive Insights

By integrating internal and external data, see how you can enhance decision-making and efficiency, manage diverse data sources, and reap the benefits of a single source of truth for your organization.

Safety As A Science: Analytics For Trial Safety And Pharmacovigilance

Clinical trials can expose both predicted and unexpected safety signals. Understand why surveillance must therefore look beyond expected adverse events to detect possible safety signals.

10 Data Linkage Use Cases To Future-Proof Your Clinical Trial

Here, we explain how integrating clinical trial data with real-world data can revolutionize patient insights and enhance evidence generation through ten innovative Medidata Link use cases.

Auto-Populate eCRFs On Study Day One

Learn how OpenClinica Unite automates source data acquisition from EHRs to EDCs and eCRFs to view study data safely, accurately, and efficiently where and when it is most needed.

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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.

TRIAL MONITORING

Insights Into TMF Challenges And Solutions — Part 2

In part 2 of this two-part Q&A, Nicole Palmer, CEO and president of consulting firm Granular Level, gives some good career advice for TMF professionals and talks about TMF audits and the EU’s Clinical Trials Information System (CTIS).

Top 5 Benefits Of Using eLogs In Clinical Research

Unearth how embracing these specific approaches ensures that technology becomes a true ally in enhancing precision, accessibility, and collaboration within the intricate realm of clinical research.

How To Achieve Inspection Readiness

Enable productive interactions with inspectors through Inspection Readiness (IR) gap assessments, and propel to the next phase of development.

EVENTS

Global Clinical Trial Disclosure And Data Transparency Conference

Sept. 23-24, 2024 | Arlington, Virginia | 7 AM – 7 PM
Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics. Click here to register!

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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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