Main description:

Clinical trial management is designed to show the various activities that are involved in clinical trials and understand their processes, which are essential for planning and implementing a successful clinical trial. This book also facilitates the understanding of the importance of ethics in clinical studies and the evolution of various guidelines, rules and regulations for the management of a clinical trial. Recruitment and retention of valuable patients are critical to the success of a clinical trial and hence pose a large number of challenges for the management team to complete the trial in multiple countries with the desired number of patients enrolled in time. This book also helps readers to understand the strategies to tackle issues like enrolment of a special population, cultural and socio-economic and language issues that act as a potential barrier in clinical trial management.

Contents:

Project management; Inspection and audits; Regulatory affairs; Pharmacovigilance; Medical affairs; Patient recruitment and retention; Ethics in clinical research.