Academic Research & Methodology

Biostatistics & Clinical Trial Methodology

Practical Guide from Protocol Design to GCP Compliance

By Rajesh Sharma
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Rajesh Sharma
MD (Pharmacology), PhD

All India Institute of Medical Sciences (AIIMS)

Distinguished pharmacologist with over 25 years of research in clinical therapeutics.

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paperback 1st Edition Peer-Reviewed ISBN: 978-81-948123-6-3

Biostatistics & Clinical Trial Methodology

Practical Guide from Protocol Design to GCP Compliance

Rigorous Statistical Foundations

Clear, step-by-step methodologies for Phase I-IV clinical trial design, survival analysis, sample size calculations, power analysis, and ICH-GCP regulatory filing.

ISBN 978-81-948123-6-3
Publisher RxInk Publications
Edition 1st Edition
Language English
Format Paperback
Page Count 380 Pages
Publication Date 20 Apr 2026
Keywords biostatistics, clinical trials, sample size, ICH-GCP, epidemiology
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Primary Author RX-CERT-2026-2D741A
Dr. Rajesh Sharma
Professor & Head, All India Institute of Medical Sciences (AIIMS)
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