Newsletter | March 18, 2026

03.18.26 -- Informed Consent Isn't Broken — But It's Barely Working

TRIAL MANAGEMENT

Informed Consent Isn't Broken — But It's Barely Working

Former FDA Commissioner Dr. Robert Califf has been blunt about what’s wrong with informed consent in clinical trials. This article offers a high-level look at his three-part Substack series, exploring how consent became more about legal protection than patient understanding — and what needs to change.

Global Reach, Biotech Speed: Clinical Packaging, Labeling That Delivers

By integrating scalable operations, reliable supply chains, and deep regulatory expertise, biotech companies can eliminate bottlenecks, improve efficiency, and accelerate trial execution.

5 Tips To Put The Right Systems In Place For Successful Clinical Trials

Before you dive into clinical trials, ask yourself: Is my company operationally ready to handle the complexity? Learn about key upgrades that can help you streamline operations and reduce risk.

Master Protocols: Implementing Effective Treatment Adaptations

From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.

Leading With Purpose: Meg Hooton's Global Journey in Biotech

Biotech leadership requires vision, adaptability, and purpose. Aligning values with strategy and fostering collaboration empowers teams and drives innovation in a rapidly evolving industry.

Critical Supply Strategies For CROs

Leveraging the expertise of a chosen clinical supply partner can be a valuable resource. Examine key considerations when partnering with a CRO in order to deliver a successful clinical supply strategy.

Phase 1 Trial In Painful Diabetic Peripheral Neuropathy

A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.

End-To-End Biostatistics In Clinical Research

Optimize your clinical trials with end-to-end biostatistics and innovative trial designs. Your trial will benefit from submission-ready data, modern safety tech, and scalable, cost-effective FSP.

DECENTRALIZED TRIALS

Bridging Community And Central Hospitals With Japan's DCT Model

Regulatory support and improved DCT infrastructure, as well as a uniquely Japanese approach to site relationships, are advancing the DCT landscape in Japan, explains consultant Takuma Matsunaga.

Why We Need To Look To The Future Of Clinical Trials

Explore how decentralized trial elements, community-focused site networks, and patient-centric infrastructure can improve recruitment, data quality, equity, and efficiency.

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