Newsletter | September 17, 2025

09.17.25 -- Social Media And A Site-Less Model Lead To Pandemic-Era Success

SPONSOR

Spotlight the Best in CRO Partnerships—Share Your Voice!

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!

TRIAL MANAGEMENT

How Clinical Trials Are Approved in Australia

Megan Robertson explains the Australian process for authorizing trials. Unlike the US, where the FDA approves first, Australia delegates reviews to Human Research Ethics Committees (HRECs). Once approved, sponsors notify the Therapeutic Goods Administration (TGA), which acknowledges within two weeks. She highlights how nearly all studies use this streamlined Clinical Trial Notification (CTN) pathway.

Health Economics And Outcomes Research (HEOR) Explained

Learn about this accessible way to understand what HEOR is, how it’s used, and its impact on people and healthcare systems.

Solutions To The Challenges Of Oncology Trials

This significant Phase III trial, one of the largest global studies in head and neck cancer, faced considerable challenges including enrollment delays and an intricate study design.

How Can RWE Inform Clinical Trial Design In Drug Development?

RWE empowers researchers to streamline patient recruitment, choose data-driven trial sites, engage in adaptive trial design, and uncover new treatment possibilities.

Making Good Clinical Practice More Understandable

What role does Good Clinical Practice (GCP) play in the clinical research ecosystem and how does it safeguard participant rights, safety, and confidentiality while fostering compliance?

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 with minimal disruption.

Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

Unlock Next-Gen Prescription Insights With A Comprehensive Solution

Understanding patient treatment journeys is paramount. PES offers a comprehensive solution, providing a holistic view of how patients navigate their treatment pathways.

DECENTRALIZED TRIALS

Social Media And A Site-Less Model Led This Trial To Pandemic-Era Success

Genescopy's Chief Science and Medical Officer Erica Barnell, MD, Ph.D. explains how social media recruiting and a site-less trial design helped the company's CRC-PREVENT Phase 3 trial succeed.

Improving Patient Outcomes Using eSource Software In Clinical Trials

As the demand for patient-centric clinical trials grows, eSource platforms will play an increasingly vital role in facilitating efficient, compliant, and innovative research methodologies.

Transforming Cardiac Monitoring With 6-Lead And 12-Lead Devices

Learn how you can monitor a large number of cardiac conditions in real-time and support clinical trials across phases and TAs.

CHOOSE YOUR OWN ADVENTURE

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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