Clinical Trial Management
An Overview
Published on 28. February 2014
Book
Hardback
250 pages
978-1-907568-66-4 (ISBN)
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.
More details
Series
Language
English
Place of publication
Cambridge
United Kingdom
Publishing group
Elsevier Science & Technology
Target group
Professional and scholarly
Dimensions
Height: 234 mm
Width: 156 mm
ISBN-13
978-1-907568-66-4 (9781907568664)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Persons
Dr Umakanta Sahoo, Executive Director, Asia Pacific and Managing Director, India for Chiltern, (a Contract Research Organisation) is a bioscience graduate, having MBA and PhD (Management) degrees and over 18 years of experience in the pharmaceutical industry and CRO sector. He has worked in various positions in pharmaceutical marketing, exports, clinical monitoring operations, project management, regulatory affairs and biometrics. He is a frequent speaker at industry conferences and academic institutions and is on the advisory board and academic council of several well known institutions. Dr Dipti Sawant, Manager, Clinical Monitoring. She is a Bioscience Graduate with postgraduate degree Biochemistry and PhD in Applied Biology and ACRP Certified Clinical Research Professional. She has an experience of more than 8 years in Clinical Research and has experience in working with various therapeutic areas like Oncology, Nephrology, Dermatology, Neurology, Ophthalmology, Burns, Diabetes, Endocrinology, Anesthesia, Hepatology. To her credit she has many publications in the leading pharma magazines, newspapers and journals and has also received Gufic Prize for Best paper Award for one of her research project.
Content
Project management; Inspection and audits; Regulatory affairs; Pharmacovigilance; Medical affairs; Patient recruitment and retention; Ethics in clinical research.