Global Clinical Trials - Abdelhakim, Essam
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The book is a comprehensive guide to global clinical trials, covering critical aspects of conducting international medical research. Key highlights include: Core Focus Areas 1. Regulatory Landscape * Detailed exploration of clinical trial regulations across different countries * Comprehensive overview of regulatory requirements in the US, EU, UK, Japan, China, India, and other regions * Emphasis on navigating complex international regulatory environments 1. Ethical Considerations * In-depth examination of ethical principles in clinical research * Focus on protecting vulnerable populations *…mehr

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Produktbeschreibung
The book is a comprehensive guide to global clinical trials, covering critical aspects of conducting international medical research. Key highlights include: Core Focus Areas 1. Regulatory Landscape * Detailed exploration of clinical trial regulations across different countries * Comprehensive overview of regulatory requirements in the US, EU, UK, Japan, China, India, and other regions * Emphasis on navigating complex international regulatory environments 1. Ethical Considerations * In-depth examination of ethical principles in clinical research * Focus on protecting vulnerable populations * Addressing cultural sensitivities in global trial design 1. Trial Phases and Design * Comprehensive breakdown of clinical trial phases * Strategies for designing multi-regional trials * Techniques for ensuring data integrity and participant safety Unique Contributions * Practical strategies for managing international clinical trials * Insights into emerging technologies like AI in clinical research * Guidance on decentralized clinical trials * Recommendations for strengthening global research collaboration The book serves as an essential resource for researchers, providing a holistic approach to conducting ethical, compliant, and innovative clinical trials across diverse global contexts
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