Clinical Research: Phase 1 - Phase 4

Mastering Dose Escalation Studies Part 2: Charting a Clear Path from Planning to Execution

Dose escalation studies are pivotal in the early phases of clinical drug development for evaluating the safety profile of a new therapeutic agent and identifying a recommended dose for further investigation. These studies lay the groundwork for understanding the pharmacokinetic and pharmacodynamic properties of novel therapies and, if designed and executed thoughtfully, can move seamlessly...

Mastering Dose Escalation Studies Part 1: Optimizing Efficiency in Phase I Trial Execution Using Adaptive Design

Adaptive design is a progressive approach that utilizes different statistical modeling to allow for modifications to enrollment in a clinical trial after study initiation without undermining data integrity and validity. This methodology is particularly beneficial and increasingly common in phase 1 clinical trials, which focus primarily on safety, tolerability, pharmacokinetics, and pharmacodynamics. The essence of...

Immune Checkpoint Inhibitor Therapy: Optimize Dose and Patient Selection to Maximize Efficacy and Access

Since the approval of ipilimumab in 2011 for metastatic melanoma, immune checkpoint inhibitors (ICI) have shifted the treatment paradigm in oncology. Now increasingly indicated as first-line treatment of certain metastatic cancers, ICIs can trigger deep, durable responses and offer significant survival benefit. However, the majority of patients do not respond and many epeirence immune-related adverse...

5 Stages of Medical Device Development

Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which...

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...

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...

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...

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...

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...

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...