Newsletter | March 25, 2026

03.25.26 -- U.S. Pharma Tariffs And MFN: Manufacturing And Procurement Impact

SPONSOR

The Phase 2 Endpoint Dilemma: Bridging Subjective Scales and Objective Measures in Neurodegenerative Trials.

This webinar discusses challenges in Phase 2 neurodegenerative trials, where slow disease progression and insensitive traditional scales like ADAS-Cog and MDS-UPDRS can miss meaningful treatment effects. The session also presents frameworks for integrating cognitive, functional, and biomarker measures and shows how real-world evidence can guide endpoint selection and improve go/no-go decisions for emerging therapies. Click here for more.

DECENTRALIZED TRIALS

What The FDA Says About Investigator Responsibilities In DCTs

Learn exactly what the FDA says about the use of healthcare providers (HCPs), telemedicine, licensing, and practice standard requirements when executing a DCT.

Rethinking Lab Logistics: Delivering The Complex Without Compromise

Through Home Trial Support (HTS), it is possible to carry out even the most demanding sampling protocols safely, consistently, and at scale—bringing collection and processing directly to patients.

TRIAL MANAGEMENT

My SCOPE Groundhog Day Experience

From feasibility inefficiencies to overdesigned trials and overloaded investigative sites, the conversations at SCOPE were thoughtful and candid. The problem isn’t ignorance. It’s execution. Until simplification shows up in shorter timelines, leaner protocols, and measurable relief for sites, we may continue gathering each year to discuss the same issues — with the same data.

U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact

Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

Accelerating Parkinson's Disease Clinical Research

Centralized PD trials cut variability, speed enrollment, and enable genetic stratification, delivering high‑quality data and faster progress from early‑phase research to late‑stage development.

Advancing Ovarian Cancer Therapies: Clinical Trends And Challenges

Ovarian cancer remains one of the deadliest gynecologic malignancies. Successful clinical trials in this space demand deep therapeutic expertise, operational agility, and global coordination.

BCVA, OCT, And IOP Testing In Clinical Trials

Are minor inconsistencies in room setup and technician technique quietly compromising your study data? Learn how closing small operational gaps can prevent major downstream risks.

A Novel Digital Measure For Tracking Disease Progression In DMD

This presentation explores the groundbreaking study that introduces Six-Minute Activity 95th Centile (6M95C), a novel accelerometry-based tool that provides a real-world view of functional capacity.

Expedite Drug Development With An Integrated CDMO-CRO Model

From optimizing first-in-human strategies to leveraging AI-enabled digital architectures, the integrated CDMO-CRO services model reduces risk and maximizes program value.

The Real Payoff Of Reusable IRT/RTSM System Design

By utilizing consistent, repeatable system builds, sponsors gain significant advantages during protocol amendments and operational changes.

The Ultimate Guide To Clinical Supplies For Japan Studies

Our team in Japan provides comprehensive services including primary and secondary clinical packaging and labeling, comparator sourcing, cold chain storage, and local and global distribution.

Transforming the Path To Life‑Changing Patient Therapies

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

Biotech-Tailored Clinical Development

Strategic planning, data-driven decisions, and global coordination accelerate clinical timelines while ensuring quality. Explore risk-based monitoring and practical ways to overcome complexity.

ATLAS Label Translation Solution

Simplifying label requests, integrating translation and regulatory support, and using paperless workflows can reduce turnaround times while maintaining high-quality label content.

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You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. To make changes to your newsletter selections, update your topic preferences.

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  • Clinical Trial Technology (Tuesday)
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  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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