Newsletter | November 19, 2025

11.19.25 -- The Real Story Behind SOGI Data

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Help shape the future of CRO excellence! Take part in the 2025 CRO Leadership Awards Survey, conducted by Tufts CSDD and Clinical Leader. Your confidential feedback will determine the top CROs in project management, services, culture, and more. Winners will be celebrated through Clinical Leader events—don’t miss your chance to spotlight outstanding collaboration in our industry!

DECENTRALIZED TRIALS

4 Steps To Make A Business Case For Digital Endpoints

Anita Burrell explains how to build a business case for including digital endpoints and the elements to consider.

Propelling Research Forward With Healthcare-First Sites

The future of clinical research is optimized trials: research optimized for patient comfort and access. Explore how optimized trials can transform your research approach and improve patient engagement.

TRIAL MANAGEMENT

The Real Story Behind SOGI Data

In this clip, Dr. Jessica Brecher of Tectonic Therapeutic reveals why many trial sites refuse to activate sexual-orientation and gender-identity (SOGI) questions — from investigator discomfort to patient fears — and why collecting these data is scientifically essential.

Navigating Project Optimus And The Oncology Development Landscape

Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.

Empowering Patients With Self-Administration Drug Delivery Devices

Discover how these devices offer solutions to the challenges of precise dosing, patient compliance, retention, and safety, uplifting the overall trial experience and providing real world insights.

What's Next For Global Drug Development? What To Know

Explore how early-stage sponsors can adapt to dynamic changes, including new FDA initiatives such as AI-driven reviews and user fee changes. It is important to design trials with a global perspective.

Global Literature Monitoring For Regulatory-Grade Safety Intelligence

Enlist an expert team for your end-to-end literature surveillance solutions, utilizing advanced tools and tailored strategies to deliver compliant, audit-ready outputs aligned with global requirements.

Optimize Your Clinical Supply Chain With Intelligent Forecasting

Enable smarter clinical supply management and learn how seamless integration and data-driven planning turn supply chain uncertainty into confident, cost-effective decision-making.

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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.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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