Newsletter | April 12, 2024

04.12.24 -- Navigating The Latest FDA Draft Guidance: Data Monitoring Committees

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TRIAL MONITORING

5 Practices For Well-Organized Source Data

Guest Column | By Kaitlin Bova, Moderna

ALCOA+ — or Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring, and Available — is the basis for these must-follow tips from Moderna Senior Manager of R&D Quality Kaitlin Bova.

FDA Continues Diversity Push

Article | By Lya Rebelo, Citeline

Review the FDA's revised 2016 diversity guidance, which establishes clear expectations and standardizes recommendations for gathering and reporting race and ethnicity data.

CLINICAL DATA MANAGEMENT & ANALYTICS

Navigating The Latest FDA Draft Guidance: Data Monitoring Committees

Guest Column | By John Giantsidis, president, CyberActa, Inc.; and Remco Jan Geukes Foppen, Ph.D.

In a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials. The public comment period ends April 15, 2024.

The Write Side Of AI: Helping Hands, Not Replacement Plans

Article | By Jenny Minigh, inSeption Group

AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.

The Guide To Driving Data Quality Across The ‘5 Vs’ Of Clinical Data

e-book | Medidata, a Dassault Systemes company

See how technology continues to inform and optimize clinical data processes to address the “5Vs” — volume, variety, velocity, veracity, and value — of data that are reshaping clinical data management.

Supporting Early Phase Oncology Research With The Right CDMS

Article | By Rod McGlashing, Medrio

Better understand how the evolving landscape drives innovation, why your data capture strategy needs the right technology foundation, and what to look for in a CDMS/EDC system for early-phase oncology.

Applied AI For Enhanced Clinical Data Operations

Webinar | ThoughtSphere

Watch as experts from ThoughtSphere and Signant Health delve into tangible instances and real-world applications presently accessible for expediting and enhancing the operational aspects of clinical trials.

Empowering Clinical Trial Sponsors With Analytics

Article | Revvity Signals Software, Inc.

Explore data challenges faced by sponsors, the underlying problems driving those challenges, and flexible processes and solutions designed to help overcome them.

Evidence-First Approaches To Digital Measures In Clinical Research

Video | ActiGraph

In this clip, professionals from ActiGraph describe what sets the company apart from others within the industry and what you can expect when working with their team.

Here To Help You Succeed

Video | IQVIA Biotech

IQVIA Biotech is a standalone business of IQVIA with dedicated teams delivering clinical development solutions. Discover why they're the CRO partner of choice for biotech companies around the world.

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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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