Newsletter | April 11, 2024

04.11.24 -- New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials

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Webinar: Safety at the Center – The Synergistic Role of Drug Safety in Clinical Trial Operations

In drug safety and pharmacovigilance, collaboration isn’t just a buzzword — it’s an essential component that can impact patient safety and the success of your product. Join us in this webinar as we highlight the importance of effective interpersonal leadership in your drug safety program and reveal the operational and financial efficiencies that can result from a collaborative dynamic. Click here to learn more.

OUTSOURCING MODELS

Channel Your Inner Child To Become A Better Clinical Research Professional

Guest Column | By John R. Nocero, Ph.D., and Andrea L. Bordonaro, MAT

Sites, CROs, and sponsors sometimes have contentious relationships. It doesn't have to be that way. Discover how to leverage The Zones of Regulation to better manage emotions and become a better partner and CRP.

The Unique Value Of Integrated Safety Services And Technology

White Paper | By Archana Hegde, Richard D’mello, and Scott Fonseca, IQVIA Safety & Regulatory Compliance

In your search for an integrated safety partner, begin by assessing a vendor’s previous experience and whether their PV knowledge aligns with the needs of your product portfolio.

FSP Trends Report

Article | PPD FSP Solutions

This guide for biopharmaceutical and biotechnology companies can be used to optimize engagements with FSPs, leveraging current trends for timely and cost-effective project completion.

GMP Auditing, Compliance, And Specialized Consulting

Brochure | Advarra

Learn how we're assisting clients to reduce risk and ensure adherence to good manufacturing practice, good laboratory practice (GLP), and good tissue practice (GTP) standards.

REGULATORY & COMPLIANCE

New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials

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

In a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials.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

Decades Of Breakthroughs: Learning From A Life Sciences Organization

Article | Sikich

Gain insights from the founder and CEO of Jaguar Health Lisa Conte on building a successful life sciences organization through innovation.

Are You Ready To Begin Planning Your IND Submission?

Webinar | Veristat, Inc.

Explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND.

Regulatory Operations Support

Datasheet | Halloran Consulting

Begin addressing document preparation requirements, document formatting, PDF publication, eCTD compilation, and submission needs through the FDA's Electronic Submissions Gateway.

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You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. 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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