Newsletter | September 8, 2025

09.08.25 -- Trials Without Borders: Regulatory & Site Landscapes

SPONSOR

Revolutionize your approach to clinical trials at DPHARM: Disruptive Innovations to Modernize Clinical Research, taking place September 16–17, 2025, in Philadelphia. This conference showcases cutting-edge strategies and technologies designed to reduce patient and site burden, streamline operations, improve data quality, and accelerate access to therapies.

CLINICAL SITES

Trials Without Borders: Regulatory & Site Landscapes

Experts Megan Robertson and Tina Soulis, Ph.D. discuss the regulatory and ethical landscape for conducting clinical trials in Australia. Topics covered include everything from CTA/IND submission processes and EC/IRB review timelines to ICH E6(R3) alignment and decentralized trial requirements. They also delve into the Australian site landscape.

Global Start-Up For Multinational Geographic Atrophy Trial

This partnership allowed a leading biopharmaceutical company to navigate the complexities of a Phase IIb study investigating a novel pegylated RNA adapter for geographic atrophy secondary to dry AMD.

A Day In The Life Of A Clinical Research Site

Clinical research site coordinators are the unsung heroes of trial execution—managing complex protocols, supporting participants, and navigating fragmented systems, all while ensuring study integrity.

Clinical Trials Without Boundaries: Multi-Site Solutions

As early-phase trials grow complex, multi-site solutions help you overcome single-site limits—unlocking broader patient access and greater flexibility.

Empower Your Research Sites With A Full-Service Marketing Solution

Whether you're launching a site-level initiative or managing multi-site enrollment campaigns, you need a platform specifically engineered to empower your research sites.

SPONSOR

Biomarkers & Precision Medicine US 2025: Redefining the Future of Healthcare

Join us in San Francisco, as Biomarkers & Precision Medicine US 2025 returns for its 9th year at the Westin St. Francis. Join top pharma, biotech, and academic leaders exploring breakthroughs in spatial biology, AI-powered pathology, and multi-omics integration. Hear from experts like Lee Hood and Ida Sim. Discover how precision medicine is reshaping diagnostics, drug development, and personalized care. Claim your free ticket.

PATIENT CENTRICITY

Misconceptions About Cancer Clinical Trials And How To Overcome Them

Medical oncologist Wasif Saif, MD, MBBS, discusses many of the misconceptions held by patients and clinicians about cancer clinical trials.

The Hidden Healthcare Benefits That Home Trial Support Provides

Examine home HTS enhances both patient & caregiver safety and wellbeing, while alleviating pressures on sites and generating greater ROI for sponsors.

Clinical Innovators: Co-Designing With Patients

In this thought-provoking conversation with leading voices in the biopharma sector, Hilary Thomas discussed how patient insights can be meaningfully woven into clinical trial design.

PATIENT RECRUITMENT

Don't Underestimate HCP Awareness Campaigns

How effective can HCP awareness campaigns be when trying to recruit patients for clinical trials? Jason Elenberger gives some examples of these and other simple tactics that can go a long way when recruiting patients.

Searching For The Oasis In A "Cardiology Desert"

Dr. Charles Bridges, a leading cardiac surgeon, identifies the contributing factors to cardiac care obstacles and the adverse effects of “Cardiology Deserts”.

Why Patients Drop Out And How To Close The Gap

This Patient Experience Optimization (PXO) model bridges the critical gap where most clinical trial patients drop out before reaching consent.

Understanding The FDA's Push For More Representation

Take action to improve diversity in clinical trials by addressing underrepresentation and ensuring equitable access to medical interventions, as emphasized by the FDA’s new 2025 guidance.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Monday edition of the Clinical Leader newsletter, focusing on Clinical SitesPatient Centricity, and Patient Recruitment. 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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