Newsletter | October 1, 2026

10.01.26 -- Health Policy Is Shifting Fast — Is Your Compliance Strategy Keeping Pace?

SPONSOR

 

Webinar: Operationalizing Adaptive Design for FDA's One-Trial Era

The FDA’s 2026 One-Trial pathway is changing how sponsors approach pivotal trial design. In this webinar, Veristat’s adaptive design experts explore the statistical frameworks, regulatory strategies, and practical considerations for building a defensible single pivotal trial. Hear a real-world case study demonstrating how adaptive design can reduce development timelines and costs while maintaining trial quality, offering insights for today’s clinical development teams. Click here to learn more.

REGULATORY COMPLIANCE

 

Take The Guesswork Out Of Charcot-Marie-Tooth Disease Research

A new Charcot-Marie-Tooth guidance introduces practical recommendations to help sponsors design clearer, more patient-centered, regulator-ready trials.

 

Key Health Policy Priorities Shaping The Second Half Of 2026

See late‑2025 policy actions, including international pricing agreements, new payment models, and global regulatory changes, while previewing key themes expected to shape 2026 health policy.

 

Aligning Global Standards For ICH E6(R3) And Artificial Intelligence

Global standards and AI are transforming clinical research. Learn why mastering ICH E6(R3) and risk-based compliance is critical for data integrity and future success.

 

Protocol Builder And Informed Consent Builder Version 2.0

Built by research compliance experts, this platform streamlines the protocol-writing process through customizable templates, workflow tools, and collaboration support for research teams.

 

Simplify Investigational Drug Management

Streamline clinical trial pharmacy operations, slash manual documentation time, and maintain continuous audit readiness across complex studies.

SPONSOR

 

Webinar: What’s Working in AI-Enabled Respiratory Trials: From Recruitment to Site Readiness

Respiratory clinical trials face growing challenges, from shrinking patient populations and complex protocols to competition for patients and sites. How can AI and digital solutions help? This webinar explores practical approaches to optimize study design, predict enrollment, reduce participant burden and detect emerging risks earlier. Discover how technology can support efficient, patient-centric trials while strengthening quality and execution. Click here to learn more.

OUTSOURCING MODELS

 

Small Biotech Can Outsource The Work, But Not The Thinking

Robert Goldman explains why small biotechs can outsource clinical trial work — but never accountability. His advice on CRO oversight and responsible AI adoption shows how lean sponsors can gain efficiency without surrendering the judgment needed to spot risks and protect their programs.

 

Fast-Tracking FIH To PoC: Strategies For Accelerated Drug Development

Three factors often decide success or failure in FIH studies: integrating biomarkers and pharmacodynamic endpoints, including patients in the trials, and leveraging manufacturing infrastructure.

 

Maximizing Early-Phase Trials Of CNS-Active Drugs

Understand how specialized assessments and early-phase clinical strategies can generate meaningful safety, pharmacology, and proof-of-concept data.

 

Advanced Drug Delivery And Device Combination Product Solutions

PCI Pharma Services' end-to-end injectable services, comprehensive approach, and dedication to excellence provide convenient, easy-to-use, patient-centric therapies.

 

Why Functional Outsourcing Is Important To Clinical Development

Why is functional outsourcing important in today's clinical development environment, and where can you find scalable support that will flex with your changing needs?

 

Immune Challenge Models For Early Drug Development

Inflammation is a primary pathogenic process in a wide range of diseases, including rheumatoid arthritis, cardiovascular disease, oncology and neuropsychiatric disorders.

Connect With Clinical Leader: