Newsletter | July 30, 2025

07.30.25 -- Hidden Compliance Risks In Start-Up That Could Derail Your Clinical Trial

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Discover how to apply ICH E6 R3 in practice during this expert-led discussion on risk-proportionate approaches in clinical trials. Learn how to integrate and analyze data to streamline oversight, enhance compliance, and improve patient safety. Registration for this Clinical Leader Live digital event is free thanks to the support of Revvity, Medable, and PPD Clinical Research Business of Thermo Fisher Scientific.

DECENTRALIZED TRIALS

 

Decentralized Clinical Trials: Embracing The FDA's 2024 Final Guidance

In Sept. 2024, the FDA unveiled a final guidance aimed at advancing decentralized clinical trials. This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.

 

Decentralized Solutions: Expanding Clinical Trial Access

The clinical research landscape is increasingly adopting decentralized clinical trials (DCTs) and hybrid designs to enhance patient accessibility, inclusivity, and diversity.

 

Modernizing Clinical Research With Patient-Centric Digital Data Collection

Accelerate clinical trial modernization with streamlined collection of continuous, high-precision data centered on the patient.

TRIAL MANAGEMENT

 

Hidden Compliance Risks In Start-Up That Could Derail Your Clinical Trial

Kulkarni Law Firm Senior Attorney Edye T. Edens explores the risks embedded in clinical trial start-up activities, such as site activation, contract execution, delegation of responsibilities, and cross-border data flows.

 

Flexibility In Phase 1 Study Timing

Combining certain Phase 2 studies with the Phase 1 protocol gives you earlier access to data, which enables more informed go/no-go decisions early in the program. 

 

Precision In, Precision Out: Elevated Kitting Strategies For Clinical Trials

As biomarker-driven clinical trials become increasingly complex, the design and management of clinical trial kits play a pivotal role in ensuring operational success and scientific integrity.

 

Organizational Assessment For A Large MedTech Company

Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

 

Oncology Expertise Across Cell & Gene Therapies, Biologics, And Small Molecules

As a full-service oncology CRO, our extensive oncology expertise, coupled with an end-to-end approach, helps accelerate your clinical oncology programs.

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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