Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

Deviating from the Conventional: Decentralizing Pediatric Rare Disease Clinical Research

Decentralized clinical trials (DCTs) have emerged as a promising solution to address the unique challenges of pediatric rare disease research. In this blog, we discuss the intricate landscape of conducting clinical research in pediatric rare diseases, identify the unique challenges, discuss the potential of decentralized trial strategies, and underscore relevant risks and considerations. Navigating the...

Clinical Research: Phase 1 - Phase 4

A 7-Step Roadmap for Operationalizing Large‑Scale Clinical Validation Studies

Liquid biopsy tests represent both a promising alternative to existing screening methods and an opportunity to develop cancer detection tests for indications where no such screening method is yet available. Given the risk associated with both false positives and false negatives, liquid biopsies intended for screening and early cancer detection are subject to a high...

Clinical Research: Phase 1 - Phase 4

5 Tips for Designing and Operationalizing Natural History Studies

Natural history studies document the natural course of a disease, starting just prior to its inception and progressing through its pre-symptomatic phase and different clinical stages until the patient is cured, chronically disabled, or deceased. These studies play a crucial role in drug development—especially for rare diseases. In addition to providing insights that advance discovery...

Clinical Research: Phase 1 - Phase 4

Advancing Health Outcomes for All: Addressing Diversity and Ethnicity Data Challenges in Global Clinical Research

In the business of pharmaceutical and MedTech clinical development, the significance of robust data cannot be overstated. It serves as the cornerstone for informed decision-making and cultivates an environment where innovation thrives. However, when confronted with the task of comparing ethnicity data across diverse countries, a myriad of challenges and intricacies surface, warranting a thorough...

Clinical Research: Phase 1 - Phase 4

Accelerating the Path from Concept to Market. We are Made for MedTech™

From pre-market pilot to post-market clinical investigation, we have vast experience across all stages of clinical development. With more than 165 projects conducted globally within the last five years, our medical device expertise covers a wide range of medical devices across all classes. As a dedicated MedTech business unit within a global CRO, we support...

Clinical Research: Phase 1 - Phase 4

The Ascendance of Site Managers to Meet the Dynamic Needs of Clinical Research

The increasing complexity of clinical trials requires a re-assessment of the functions of site management and monitoring. Both roles have traditionally been the purview of clinical research associates (CRAs), who have typically spent 60%-80% of their time on monitoring and only 20%-40% on site management. Traditionally, CRAs have a range of monitoring and site management...

Clinical Research: Phase 1 - Phase 4

4 Steps to Implementing DEI in Clinical Trial Design and Patient Recruitment

Welcome to part two of our blog series focused on the integration of diversity, equity, and inclusion (DEI) into clinical research. If you missed part one of the series that highlights recent FDA initiatives and legislative changes behind these developments, click here. In today’s clinical research environment, sponsors face the challenge of comprehensively incorporating DEI...

Development Strategy

Premier Insight 284 | Leveraging Experienced Research Networks for Global Psychiatry Studies in Difficult-to-Access Populations

Introduction When approached for an early-in-illness schizophrenia trial, Premier Research knew that patient recruitment would be challenging and require creative approaches for success. Based on our experience in mental illness studies and with this indication, we recognized the importance of identifying sites where patients were already being diagnosed and treated. To achieve this, the Premier...

Clinical Research: Phase 1 - Phase 4

FDA’s Push for DEI in Clinical Trials: What Sponsors Need to Know in 2024

In the ever-evolving field of global clinical research, the integration of diversity, equity, and inclusion (DEI) has become a pivotal focus, especially considering recent FDA initiatives and legislative changes. The U.S. Food and Drug Administration’s (FDA) ongoing efforts, coupled with the enforcement of the DEPICT Act and impending final regulatory guidance, highlight the urgency and...

Clinical Research: Phase 1 - Phase 4

7 Reasons to Ditch Traditional Monitoring in Favor of a Centralized Strategy

Centralized monitoring’s state-of-the-art approaches and tools are reshaping clinical trials’ efficiency, accuracy, and overall effectiveness. Here we discuss the core methodologies that underpin centralized monitoring—study-level and patient-level data analysis—and how these strategies collaboratively refine the monitoring process. Moreover, we outline seven compelling reasons why shifting from traditional monitoring to a sophisticated, centralized approach is not...