Newsletter | July 31, 2025

07.31.25 -- 6 Tips To Ensure Revenue Integrity And Compliance In Clinical Operations

OUTSOURCING MODELS

How An Australia-First Strategy Cut 63% From Our R&D Spend

Etira CEO Russell Hayward explains how conducting the company's early-stage trials in Australia has yielded big savings, shortened timelines, and produced FDA-ready data.

How ClinAI Solves 10 Roadblocks To Traditional Vendor Selection

Vendor selection in clinical trials is a pivotal process. Explore ten widespread inefficiencies in the current approach and how you can resolve them.

How To Optimize CMC And Clinical Strategies For Peptide Drugs

Advances in peptide drug delivery have opened new opportunities for peptide drug products, with non-parenteral routes of administration — such as oral and nasal — now feasible.

When Clinical Trials Drift Off Course

Recovering lost clinical trials is an art. Learn how we triage your study’s problem areas, build recovery strategies to address your drifting trial’s performance, and deliver results.

Bioanalysis Solutions

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

REGULATORY & COMPLIANCE

6 Tips To Ensure Revenue Integrity And Compliance In Clinical Operations

Discover the importance of Medicare Coverage Analysis (MCA) and the rules of National Coverage Determination (NCD) in establishing financial security and regulatory adherence in clinical operations.

Quality Metrics: How To Add Value And Meet The FDA's Expectations

Establishing and utilizing quality metrics is essential for the pharma industry's future success. Learn how to identify meaningful metrics and appropriately measure quality to make better business decisions.

Halloran's Regulatory Lens – What We're Watching In 2025

As the regulatory environment evolves in 2025, product developers face increasing complexity driven by external pressures such as tariffs and internal shifts like FDA personnel changes.

Accessing Unapproved Therapeutic Modalities In The USA And Australia

Learn about the regulatory frameworks developed by the United States and Australia to provide access to unapproved therapies for patients with serious or life-threatening conditions.

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)

Learn more about our personalized newsletters here.

Connect With Clinical Leader: