Newsletter | May 16, 2024

05.16.24 -- Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs

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How Can We Improve Clinical Trial Feasibility Processes?

Clinical Leader Live uncovers how experts work to overcome frustrations in the feasibility and site selection process for clinical trials. Hear from speakers from J&J Innovative Medicines, Takeda, and CSL Behring on ways they’ve been able to improve the feasibility assessment process. Reserve your spot today for this May 30th digital event. Registration is free thanks to the support of inSeption Group.

REGULATORY & COMPLIANCE

FDA Guidance On Standardizing Diversity And Inclusion Terminology And Collection

Guest Column | By Deborah L. Livornese, Hyman, Phelps & McNamara

Last week, the FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.

Navigating Regulatory Environments To Bring Products To Market

Podcast | Cencora PharmaLex

Explore the opportunities and challenges presented by globalization in the pharmaceutical sector as explained by Dr. Jürgen Hönig, Senior Director of Regulatory Business Intelligence.

New Drug Applications And Biologics License Applications

Brochure | Halloran Consulting

Compiling a submission meeting stringent regulatory standards requires a partner who comprehends the regulatory landscape and can craft a compelling narrative aligned with FDA expectations.

Clinical And Regulatory Strategy

Product | Novotech

Through our clinical and regulatory consulting arm, BioDesk, we are equipped to offer support from clinical regulatory specialists with particular expertise across a variety of activities.

OUTSOURCING MODELS

Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs

Guest Column | By Susan Pandya, MD, Servier

Learn what can be achieved when scientists, patients, investigators, and advocacy groups collaborate to create an innovative trial design for a potential breakthrough therapy.

New Insights Highlighted In 2024 FSP Trends Report

Article | PPD FSP Solutions

Biopharmaceutical and biotechnology companies are invited to utilize this guide to optimize engagements with FSPs, leveraging current trends for timely and cost-effective project completion.

Warning Sign #3: Inaccurate Or Low Bids From Outsourcing Vendors

Article | inSeption Group

A bad feeling in your gut is a firm starting point, but strategies exist to substantiate a bid’s value based on more than the “sniff test.”

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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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