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The varying approaches to product registration, monitoring and approvals in different countries means country-by-country compliance headaches.
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny.
Written by some of the finest experts working in the clinical trials field, Clinical Research Manual translates regulations and best practices into real-world guidance. Both new and experienced trial managers will find the information they need to set up and run every phase of a clinical research program — from drug discovery through postmarketing surveillance — in the U.S. or abroad.
Focusing on the US, Europe and Asia, Clinical Research Manual has been completely updated to make it the most current and comprehensive resource available.
The Clinical Research Manual brings you 21 chapters, each written by top experts from organizations involved in every aspect of clinical research. These experts provide you with practical hands-on advice, including:
How to plan international development of new medicines
Specific steps for registering products in the UK and Europe
Regulatory requirements in major markets, including the US and Japan
How to recruit investigators
Tips on good clinical research practice
Tips on writing reports
Advice on effective budgeting of clinical research studies
Six new chapters have been added to the 7th edition.
Dosage Form Design
Clinical Trials Organization
Product Registration in the UK and Europe
Clinical Trials of Medicines in Children
Clinical Trials of Medicines in the Elderly
Using Patient-Reported Outcomes as Tools for Clinical Practice
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Hardcover Edition — $380
Available Formats
Hardcover Edition — $380
About the Publisher
Established more than 15 years ago, Euromed Communications has a core of qualified professionals supplemented by a team of expert medical and scientific researchers. The company produces publications for the scientific community inexpensively, accurately and rapidly.