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New and experienced trial managers will find the information they need for every phase of a clinical research program.
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 in 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