Fundamentals of Contract Research Organization and Services
Unlock the essential knowledge of Contract Research Organizations (CROs) with this comprehensive guide, perfect for both freshers and professionals. Dive into the intricate world of CROs and gain a deep understanding of their functionalities, services, and business models.
Key
Pre-Clinical Explore the basics, objectives, and key components of pre-clinical research, along with regulatory perspectives.Clinical Understand the regulatory guidelines, compliance, and phases of clinical trials.CRO Learn about the roles of sponsors, ethics committees, IRBs, IAECs, trial sites, and the responsibilities of principal investigators and site staff.Business Discover the strategic aspects of CRO business, including organizational structures and internal workflows for both clinical and pre-clinical projects.Comprehensive Get detailed insights into various CRO services such as pharmaceutical testing, pre-clinical services, end-to-end project management, regulatory services, clinical operations, data management, biostatistics, quality assurance, pharmacovigilance, medical affairs, scientific writing, and BA/BE services.Regulations and Stay informed about the applicable regulations and standards governing CRO operations.This book is an invaluable resource for anyone looking to excel in the field of contract research. Whether you’re starting your career or looking to deepen your expertise, “Fundamentals of Contract Research Organization and Services” provides the knowledge and tools you need to succeed.