ESSENTIALS OF CLINICAL RESEARCH

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 Informa

Author: Ravindra B Dr Ghooi, Sachin C Itkar

Publisher: Nirali Prakashan, Educational Publishers

Publication Date: Jun 16, 2016

Number of Pages: 244 pages

Language: English

Binding: Paperback

ISBN-10: 9380725094

ISBN-13: 9789380725093