Introduction Functional Service Provider (FSP) staffing has become a crucial model in the life sciences industry, offering flexible and scalable solutions for clinical research, regulatory affairs, pharmacovigilance, and other critical functions. As the life sciences landscape evolves, driven by technological advancements and digital transformat
Introduction The Functional Service Provider (FSP) model has become increasingly popular in the life sciences industry, offering companies a flexible and efficient way to manage specialized functions such as clinical trial management, biostatistics, regulatory affairs, and data management. However, while the FSP model offers numerous benefits, i
Clinical research management plays a vital role in the successful execution of clinical trials, ensuring that every phase of research—from planning to data collection and analysis—adheres to stringent regulatory standards. It involves the careful coordination of multiple moving parts, all focused on the goal of advancing medical science and del
GxP compliance is a critical aspect of operations for life sciences organizations, encompassing a set of regulations and guidelines that govern the safe, effective, and ethical production of pharmaceuticals, medical devices, and other life science products. The term "GxP" refers to a collection of "good practice" regulations, where "x" can stand fo
As drug development continues to evolve with the advent of digital tools and solutions, the role of CRMs has grown even more complex, requiring a blend of project management, regulatory knowledge, and an aptitude for digital technologies. This section will delve deeply into the diverse responsibilities of CRMs and how they impact the overall drug d