The Changing Face of Protocol Design
Clinical trial design is evolving rapidly, driven by the growing complexity of development pipelines and mounting expectations from patients, sponsors and regulatory bodies. Across the industry, there is an increasing recognition that success is no longer just about robust science â itâs about finding the right balance between scientific rigour, operational feasibility and real-world relevance. […]
From Theory to Practice: Breaking Down Risk-Based Monitoring in Clinical Trials
The risk-based approach to monitoring emerged over a decade ago, guided by directives from the FDA. The onus of its implementation, however, was placed on sponsors and CROs. Observations reveal a spectrum of risk tolerance among sponsors, necessitating a flexible approach from CROs. Despite the diversity in risk-based decisions within the program, the unwavering objective […]
Leveraging Specialized Knowledge: The Benefits of Niche CROs
The selection of a contract research organization (CRO) is a monumental decision that can significantly impact the success of a study. While generalist CROs offer a broad range of services across multiple therapeutic areas, niche CROs specialize in specific fields, providing deep expertise and focused capabilities. This comprehensive analysis contextualizes the unique opportunities and advantages […]
Navigating Phase 3 Clinical Trials: A Project Managerâs Guide
Navigating the complexities of phase 3 clinical trials is crucial for bringing new therapies to market. These trials are the final hurdle before approval and commercialization, making their successful execution essential for delivering innovative treatments to patients. The methodology behind these phase 3 trials includes key findings, discussing their implications, and offering recommendations for future […]
Patient Recruitment Dynamics in Dermatology Clinical Trials: The Role of Seasonal Changes
Recruiting patients for dermatology clinical trials presents unique challenges, particularly due to the influence of seasonal changes. These fluctuations can significantly impact various aspects of the recruitment process, from the condition of the patientâs skin to their daily routines and lifestyle choices. Understanding these dynamics is crucial for designing effective studies and maintaining patient retention. […]
Streamlining Communication Between Sponsor, CRO, and Sites in Clinical Trials
Evolving Communication in Clinical Research Communication is a frequently discussed topic, yet it remains an ever-evolving subject. Without ongoing exploration, it becomes challenging to keep pace with necessary advancements. In the context of clinical research, a significant portion of the day is dedicated to communication. Discussions revolve around project plans, milestones, timelines, and escalation pathways. […]
Exploring the Significance of Prior Indication Experience in Conducting Clinical Trials
Clinical trials necessitate a detailed approach, with prior indication experience playing a pivotal role. This experience enhances site proficiency, offers valuable protocol insights, and enables effective focused monitoring. These elements collectively contribute to the success of the trial, ensuring that it is designed and conducted in a manner that yields reliable results, ultimately leading to […]
Navigating the Investigational New Drug Process: Steps to a Successful Application
Filing an Investigational New Drug (IND) application in the United States (US) requires careful planning and early engagement with the Food and Drugs Administration (FDA). Key strategies for success include initiating a pre-IND meeting to receive feedback, aligning dose data with FDA safety assessments, and ensuring IND-enabling studies and chemistry, manufacturing, and controls (CMC) practices […]
Optimizing Efficacy Assessments in Clinical Trials: Key Strategies and Considerations
Efficacy assessments play a vital role in clinical trials, providing essential data on treatment success. This discussion focuses on 3 main aspects: capturing clinical outcome assessments (COAs), comparing paper versus electronic data capture (eDC), and ensuring compliance with patient-reported outcomes (PROs) for at-home subjects questionnaires. Examining these elements provides a comprehensive understanding of current practices […]
Understanding the Changes in ICH E6 (R3) Guideline
As the July 2025 implementation date approaches, the revised ICH E6 (R3) guideline marks a significant evolution in Good Clinical Practice (GCP). With a complete structural overhaul and a clear emphasis on quality by design, patient centricity, and digital enablement, this update brings both challenges and opportunities for stakeholders across the clinical research ecosystem. This article outlines the most impactful changes and […]
