Newsletter | June 28, 2024

06.28.24 -- The Reality Of AI Hallucinations: A Cautionary Guide

TRIAL MONITORING

Guidelines For Registering, Reporting Summary Results On ClinicalTrials.gov

The Clinical Trials Transformation Initiative (CTTI) and the FDA investigated barriers to registration and reporting of trial results. Here are their suggestions for ensuring complete reporting.

Optimizing Feasibility: Boosting Site-Sponsor Collaboration

Determining the feasibility of a site for clinical research is a critical component of the entire trial process. Discover how automation and standardization can improve the site-sponsor journey.

Analytical Method Transfer Checklist

By following this comprehensive guide and utilizing the provided checklist, teams can ensure a smooth and efficient analytical method transfer, promoting successful formulation and process development.

How FAIR Data Principles Deliver Clinical Success

Prioritize data management that adheres to FAIR principles — findable, accessible, interoperable, and reusable — to gain operational insights that enable quick decisions and ensure participant well-being.

Efficient Data Aggregation And Oversight: A CRO Success Story

Explore how a full-service CRO and tech-driven life sciences provider streamlined data aggregation and clinical trial oversight, yielding significant time and cost savings.

CLINICAL DATA MANAGEMENT & ANALYTICS

The Reality Of AI Hallucinations: A Cautionary Guide

As the use of AI increases and expands to new functional areas within biopharmaceutical companies, leaders must understand the risks and mitigate the impact.

Key Items Auditors Look For When Reviewing An Investigator Site File

Gain insight on how to prepare investigator site files (ISF) for audits and what teams should consider when looking to enhance efficiency and compliance.

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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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