Newsletter | January 25, 2024

01.25.24 -- Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing

SPONSOR

EDC has become a premier clinical technology in improving data accuracy and reducing site burden through time and resource conservation. But which EDC do you choose? The market for clinical technologies has produced more and more solutions in recent years, making the selection process complex. Don’t miss the Clinical Leader Solutions Expo, where leading EDC suppliers will showcase their latest technologies and solutions via a virtual, interactive platform. Registration is free.

REGULATORY & COMPLIANCE

Shorten Drug Development Timelines With Asian Ethnobridging Trials

A Phase 1 ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases 2 and 3) without repeating Phase 1 development in that region and population.

Regional Comparisons Of Pharmaceutical Regulations

Uncover how performance and regulatory expectations differ for regulatory agencies in various markets, influenced by regional drug review trends, approval decisions, and regulatory guidance.

GxP Auditing, Compliance, And Specialized Consulting

Advarra’s experts can work directly with your team to provide global consulting and evaluation services related to research, clinical quality assurance, regulatory compliance, and human research protection.

Local Affiliate Product Services

Support your local safety needs and drive consistency with global requirements through end-to-end solutions with regulatory-focused medical experts and leading technologies.

OUTSOURCING MODELS

Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs

Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMPs of the clinical supply.

The Highly Potent Market And The Role Of A Specialist CDMO

Safe handling of HPAPIs is complex and the associated regulatory requirements are growing. Discover how leveraging a CDMO can ensure treatments reach patients faster, safely, and cost-effectively.

Innovation And Partnerships: The Biotech Perspective

Adeline Meilhoc, head of clinical development at ACTICOR Biotech, provides valuable insights into the distinctive needs and challenges that small biotech firms face when conducting clinical trials.

Integrating Early Development With Clinical Supply

In the era of seamless development, reducing time to the clinic and rapid approvals is key. Learn how an integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.

Patient-Focused, Data-Empowered, Delivery-Driven

Discover the ways patient access and engagement problems are being solved with data-empowered insights and operational excellence to deliver faster, higher-quality trials.

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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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