Essentials of Clinical Research

By Mr. Sachin Itkar, Dr. Ravinder Ghooi, Mr. Sachin Itkar

Introduction, Glossary& Drug Development Process, Clinical Trials on Drugs, Regulatory Strategy, Regulatory Control Over Drugs, Ethical Aspects of Clinical Research, sponsibility of Stakeholders, Clinical Trial Documents, Endpoints in Clinical Research, Site and Investigator Selection, Subject Recruitment and Selection, Meetings in Clinical Research, Data and Safety Monitoring, IND and NDA, Clinical Data Management, Safety Reporting and Pharmacoviligance, Quality Assurance in Clinical Research, Standard Operating Procedures, Clinical Research Outsourcing, Statistics in Clinical Research, Insurance and Liability, Non-compliance, Misconduct and Fraud, Intellectual Property Rights, Websites for Information, Appendices.

• Format: Paperback
• Language: English
• ISBN: 9380725094
• ISBN13: 9789380725093
• Release Date: June 2010
• Publisher: Nirali Prakashan
• Length: 244 Pages
• Weight: 0.97 lbs.
• Dimensions: 0.5" x 7.4" x 9.7"