Newsletter | October 2, 2025

10.02.25 -- Ways Biotechs Can Relieve The Burden Of Their First Clinical Trial

SPONSOR

REGULATORY & COMPLIANCE

Gottlieb Warns Leaner FDA Will Challenge ClinOps

Former FDA commissioner Scott Gottlieb told DPHARM attendees the agency is strained by staff losses and slowing policy work—leaving ClinOps teams facing tougher reviews, longer waits, and more uncertainty ahead.

The Regulatory Binder Checklist For Clinical Trial Sites

By following this checklist, research teams can enhance organizational efficiency, maintain compliance with regulatory standards, and confidently navigate the complexities of documentation management.

Key Update On Guideline For Good Clinical Practice E6(R3)

Review details of the adoption of ICH GCP E6 R3 Principles and Annex 1, as well as what preparations and next steps your organization will need to undertake.

Reviewing Protocols Across Therapeutic Areas

A successful clinical trial starts with an efficient protocol review. Get your clinical trial to the start line while ensuring participant health and safety.

OUTSOURCING MODELS

3 Ways Biotechs Can Relieve The Burden Of Their First Clinical Trial

Discover how non-profit partnerships, adaptive trial design, and real-world evidence can all play a part in helping biotech's successfully launch their first-in-human trial.

A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

The Rescue Option: Course Correcting Struggling Clinical Trials

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

5 Questions Biotechs Should Ask Before Selecting A Bioanalytical CRO

In a landscape where speed, quality, and trust are inseparable, choosing a CRO that shares your ambition is not optional; it is essential to survival and success.

Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch

Tech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.

AI-Powered Strategy Is Redefining Patient Recruitment Performance

This AI-powered platform is helping CROs and sponsors tackle the unsolved challenge they've faced for decades: clinical trials that launch late, recruit slowly, and miss enrollment targets.

Integrating Early Development With Clinical Supply

In the era of seamless development, reducing time to the clinic and getting rapid approval is key. An integrated approach can accelerate timelines, avoid communication pitfalls, and improve outcomes.

Reimagining How You Bring Life-Changing Therapies To Patients

Accelerate your therapy's path to market and create better experiences with the right partner to provide end-to-end Clinical Development expertise.

Developing Cutting-Edge Treatments For Ovarian Cancer

Developing cutting-edge treatments for ovarian cancer requires specialized expertise and a people-first approach to research.

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: