From GCP compliance and guarding against fraud to recruiting subjects and ensuring adequate informed consent, the challenges posed by running clinical trials can be overwhelming. And conducting trials across different countries only multiplies those challenges.
The varying approaches to product registration, monitoring and approvals in different countries means country-by-country compliance headaches.
Now, practical guidance on all these topics and more is available in one, expert-written volume.
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, human subject protections, statistics, budgeting . . . 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.
Released by FDAnews (published by Euromed Communications), the Clinical Research Manual brings you 20 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
Buy now to protect your savings and your studies!
Print Edition — $410
Table of Contents
The Planning of International Development of New Medicines
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