Principles and Practice of Pharmacovigilance & Clinical Data Management
Editors:
Dr. Ravi Prakash Degala • Dr. Kasangaki Wilberforce • Miss Medha Gayatri Bhatiprollu
Mrs. Udaya Kumari Tula • Dr. Durga Ganesh Jami • Mr. Prakash Nathaniel Kumar Sarella
18th February 2025
9788198765772
8198765778
Book Description
In the rapidly evolving era of drug development, the integrity of clinical data and the safety of patients are paramount. “Principles and Practice of Pharmacovigilance & Clinical Data Management” serves as a definitive bridge between academic knowledge and the practical skills required in the pharmaceutical and CRO (Contract Research Organization) industries.
This textbook is meticulously designed for students and faculty who aspire to master the twin pillars of clinical research. Unlike generic guides, this book offers a unified approach, explaining how Clinical Data Management (CDM) ensures data accuracy while Pharmacovigilance (PV) ensures drug safety, and how these two functions intertwine to bring safe medicines to market.
Featuring real-world case studies, industry-standard workflows (such as Oracle Argus and Medidata Rave simulations), and detailed explanations of global regulatory guidelines (ICH-GCP, FDA, EMA), this book is not just a study guide; it is a job-ready career roadmap.
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Contents & Chapter Previews
Introduction to Drug Development and Clinical Research
Author: Mrs. Laxmi Suma P, Associate Professor, Department of Pharmacology, Pydah College of Pharmacy
Compliance, Ethics, and Standards in Clinical Research
Author: Dr. Usha Rani Eatakota, Associate Professor, Department of Pharmaceutics, Pydah College of Pharmacy
Strategic Data Management in Clinical Research
Author: Miss Mounitha Srija Kolavanti, PharmD Scholar, Sir C. R. Reddy College of Pharmaceutical Sciences
Methods for Acquisition, Cleaning, and Validation of Clinical Data
Author: Mrs. Udaya Kumari Tula, Research Scientist, DSK Biopharma Inc., NC, USA
Medical Coding Standardization of Clinical Data
Author: Mr. Mohammed Shahnawaaz Ahamed, PharmD Scholar, Sir C.R.Reddy College of Pharmaceutical Sciences
Optimizing Study Closeout in CDM and PV
Author: Miss Devi Sravanthi Yamala, PharmD Scholar, Sir C.R.Reddy College of Pharmaceutical Sciences
Fundamentals of Pharmacovigilance
Author: Mrs. Tanuja Methra, Assistant Professor, Department of Pharmacology, Pydah College of Pharmacy
Individual Case Safety Reports (ICSR) Management in Pharmacovigilance
Author: Miss Hyndavi Trylockya Nagumantri, PharmD Scholar, Koringa College of Pharmacy
Aggregate Reporting in Pharmacovigilance
Author: Miss Pallavi Vangapandu, PharmD Scholar, Sir C.R.Reddy College of Pharmaceutical Sciences
Signal Detection and Risk Management in Pharmacovigilance
Author: Dr. Bhargav Kumar Nagalla, Assistant Professor, Sultan-ul-Uloom College of Pharmacy
Safety Databases and Technology in Pharmacovigilance
Author: Miss Veera Naga Lalitha Nakkina, PharmD Scholar, Koringa College of Pharmacy
Audits and Inspections in Pharmacovigilance
Author: Mr. Naga Santhosh Reddy Satti, UG Scholar, VJ’s College of Pharmacy
AI and Automation in Pharmacovigilance and CDM
Author: Mr. Vijay Anand Kada, PharmD Scholar, Pydah College of Pharmacy
Strategic Outsourcing and Vendor Governance in Pharmacovigilance
Author: Miss Agnitha Christeena Geddam, PharmD Scholar, Sir C.R.Reddy College of Pharmaceutical Sciences
Project Management and Operational Leadership in Clinical Research
Author: Mr. Venkata Aravind Kumar Pasalapudi, PharmD Scholar, Sir C.R.Reddy College of Pharmaceutical Sciences
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