This item is in: Biomedicine > Pharmaceutical science/technology, drug delivery
Clinical trial management: An overviewU Sahoo, India for Chiltern and D Sawant, Clinical Monitoring, India
Woodhead Publishing Series in Biomedicine No. 35
- historical background about unethical studies and the current scenario
- understanding the role and processes of each functions involved in the conduct of the clinical trial
- managing project finances and resources throughout the conduct of the study
- risk analysis and strategies involved to tackle the risk factors
- strategies adopted for enhancing patient enrolment and retention of patients
Clinical research is a complex but systematic process that follows a series of steps, rigid standard protocols, rules and regulations, set and governed by the competent regulatory authorities in each country. The rules laid down by the competent authorities invariably demand the code of ethics by which every individual involved in clinical research has to abide. Besides these ethical principles, clinical trials involves multidisciplinary functions which require planning and management, using modern research tools and techniques. In this book, the authors discuss some of these key functions in clinical trial management viz. clinical operations, project management, regulatory affairs, quality assurance, pharmacovigilance, medical affairs, and the processes involved in performing these functions for the successful running of a clinical study.
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.
ISBN 1 907568 66 2
ISBN-13: 978 1 907568 66 4
February 2014
250 pages 234 x 156mm hardback
Approx. £125.00 / US$210.00 / €150.00
Not yet published
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About the authors
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.
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Contents
Project management; Inspection and audits; Regulatory affairs; Pharmacovigilance; Medical affairs; Patient recruitment and retention; Ethics in clinical research.