Newsletter | February 26, 2026

02.26.26 -- Why Dr. Robert Califf Isn't Pulling His Punches Anymore

REGULATORY & COMPLIANCE

Pharma Procurement Can Make Or Break Startups: Let's Help Mature Our Future Partners To Secure Innovation

To secure long-term innovation, Ascendis Pharma's Ivanna Rosendal suggests pharma companies should help startup companies through their growing pains.

5 Outdated Practices Holding Back Modern Bioanalysis

Bioanalysis must replace manual processes and disjointed systems with integrated, automated platforms for continuous validation, efficiency, compliance, and to support complex modern therapies.

Vendor Selection Bias: Why Structured Decisions Often Fail

Learn how subtle influences derail decisions and discover proven safeguards that promote transparency, accountability, and shared ownership for better trial outcomes.

More Than Technology: How People Make The Difference For Customers

Technology alone doesn’t guarantee success. Here, we explain how integrated processes, skilled teams, and collaborative partnerships complement innovation to reduce risk and improve patient outcomes.

Slow The Burn: How To Make Risk-Resilient Vendor Choices

Learn how to identify common CRO selection pitfalls and apply expert-backed strategies to protect your clinical program from costly risks and delays.

Formulation Development Services

Quickly address critical formulation issues and optimizing performance. Explore services for small molecules and synthetic peptides across oral, topical, rectal, and parenteral routes.

Drug Development Experience For Biotechs

Leverage our extensive expertise across over 120 therapeutic indications to drive your success.

OUTSOURCING MODELS

Why Dr. Robert Califf Isn't Pulling His Punches Anymore

In this exclusive video interview, former FDA commissioner Robert Califf, MD reflects on quality, risk aversion, misinformation, and why clinical trials need sharper focus — not more data. 

6 Key Implications Of EU Clinical Trials Regulation

Centralized submissions, greater transparency, and stronger patient protections reshape EU clinical trials, impacting timelines, costs, and strategies for sponsors and CROs.

Shortening Drug Development Timelines With Asian Ethnobridging Trials

Learn how Asian ethnobridging trials in Phase 1 demonstrate PK similarity and help cut years off global drug development timelines.

Transforming Regulatory Processes Through AI, ML, NLP, And RPAs

Explore the rapidly evolving landscape of regulatory processes as they undergo a profound digital transformation, highlighting how emerging technologies are reshaping traditional regulatory frameworks.

Navigate The Future: Your Essential Guide To ICH E6(R3) GCP Changes

The long-awaited ICH E6(R3) guideline is here and will reshape clinical trial standards. Get ahead of the transition with a detailed comparison and strategic insights designed for sponsors and CROs.

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  • Clinical Trial Technology (Tuesday)
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