Clinical development is entering a period in which acceleration and accountability are advancing in parallel. Study teams are operating in an environment shaped by evolving regulatory expectations, expanding data sources, and rapid innovation in analytics and automation. As a result, the industry...
Site partnerships influence every aspect of a clinical trial. Sites manage patients and data across a demanding portfolio of studies, while their interactions with sponsors and CROs can shape the efficiency and quality of a study. When responsibilities are clearly...
In an industry that has historically relied on manual oversight methods, clinical trial monitoring is evolving—but not rapidly. Over the past several decades, the implementation of technology and risk-based monitoring (RBM) strategies has become essential for ensuring both data integrity...
The SCOPE US conference in early February brought together industry leaders to explore the evolving landscape of clinical research, with technology taking center stage. From AI-driven trial design to advanced data analytics and decentralized trial solutions, innovation is reshaping how...
Selecting the right sites for a clinical trial is one of the most important determinants of successful clinical trial recruitment. In an increasingly competitive clinical trial environment where study designs have become more complex and sites are more selective about...
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...
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...
In the dynamic arena of clinical trials, optimizing efficiency, maintaining cost-effectiveness, and safeguarding the integrity of collected data are important considerations. Traditional onsite monitoring has long been the cornerstone of ensuring data accuracy and patient safety. However, as technology and...