Newsletter | March 28, 2024

03.28.24 -- A Better Recipe For Sourcing Clinical Trials

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OUTSOURCING MODELS

A Better Recipe For Sourcing Clinical Trials

Guest Column | By Larry Blankstein, Blankstein Consulting Group and Sophie Gorengaut, SuperNOVA Clinical Research, Inc.

Is outsourcing still the optimal pathway for conducting clinical trials in the 21st century? A better recipe for success might include insourcing and functional service providers (FSP), sprinkled with a handful of outsourced tasks, for a more stress-free and agile clinical trial experience.

Analytical Method Development In A High Potent Facility

Q&A | PCI Pharma Services

Leveraging a CDMO to oversee all aspects of analytical method development is crucial for achieving speed in clinical trials, regulatory approval, and commercial launch.

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.

APAC Biopharma Companies: Bridge The Gap To The U.S. FDA

Brochure | Biorasi

Uncover how these regulatory and partner/outsource services are invaluable for biopharma innovators in navigating the U.S. FDA regulatory process.

REGULATORY & COMPLIANCE

Supplying Complex, Controversial, And Intercontinental Clinical Trials

Guest Column | A conversation with Amy Reichelt, Ph.D., PurMinds NeuroPharma

Planning a clinical supply strategy for a complicated substance, psilocybin, is tricky. It's even more tricky doing it from the other side of the planet. Here's one company's approach.

Best Practices For Harmonizing Global Data Disclosure

White Paper | Citeline

Learn how sponsors can address the challenge of submitting clinical trial data in a consistent and compliant manner by examining internal processes to identify and close gaps.

Key Changes For Computerized Systems And Electronic Data

Article | Florence Healthcare

Explore several modifications introduced in the updated guidelines by the European Medicines Agency regarding computerized systems and electronic data in clinical trials.

CHOOSE YOUR OWN ADVENTURE

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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