Newsletter | November 11, 2026

11.11.26 -- Running Decentralized Trials At Scale

TRIAL MANAGEMENT

Novel Science, Familiar Regulatory Pathways: Inside Tonix's Clinical Development Strategy

Tonix CEO Seth Lederman, MD, explains how the company pairs novel science with proven regulatory paths across fibromyalgia, depression, and Lyme disease.

QP Certification Of Investigational Medicinal Products In The EU And UK

Personal legal responsibility, post-Brexit certification rules, and a three-part documentation review shape how investigational batches reach patients in the EU and UK.

Phase-Appropriate Signal Detection In Clinical Trials

Are your trial safety methods right for your phase? Learn a framework that keeps medical judgment central, avoids overreading sparse early data and catches rarer risks as studies grow.

Navigating The Operational Challenges Of Next-Generation ADC Trials

See how smarter protocol design and real-time safety monitoring can ease patient burden and keep next-gen ADC oncology trials on track.

Investor Relations, Clinical Operations, And Biotech Financing

Discover how integrating clinical execution with investor strategy can strengthen your position in a tougher capital landscape and accelerate your path to market.

The Protocol Defines The Trial. Execution Should Follow It.

Protocol requirements built into the visit itself shift trial oversight from after-the-fact review to in-the-moment guidance, with deviations flagged while site teams can still correct them.

DECENTRALIZED TRIALS

DCT Benefits Are Proven, Yet Progress Is Slow

Despite the clear benefits of decentralized trials—broader reach, better retention, and higher diversity—adoption has been slow. In this interview, Sunny Kumar of Informed Ventures explains how AI is lowering costs, speeding up study builds, and pushing DCTs from fringe to future.

Running Decentralized Trials At Scale

Sponsors are recognizing the potential benefits of decentralized clinical trials, including reduced operational costs and improved recruitment and retention of more diverse patient populations.

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