Clinical Research-Trial or Medical Writing Education/Training-Courses in India

Here I created a list for the various courses related to Clinical Research-Trial or Medical Writing Education/Training, with their respective institution's name. You can get course related detailed information from the respective institution.

Academy for Clinical Excellence
Diploma for a detailed training covering every aspect of Clinical Research
Certificate Courses to Cater Continuing Clinical Research Training which includes, Foundations of Clinical Research and GCP, Ethics Committee- Composition and Function, Advanced module on Protocol Design, Overview of clinical Research and GCP for investigators, Regulations in Clinical Research, Designing case report forms, Clinical Research: From Theory to practice (Advanced GCP), Advanced GCP course and BA/BE Studies, Biostatistics and Data Management.

Aceas Clinical Research
Post Graduate Certification in Clinical Research, Institute of Clinical Research, Buckinghamshire, U.K.
Post Graduate Diploma in Clinical Research, Institute of Clinical Research, Buckinghamshire, U.K.
Continuing Professional Development Courses for Contract Research Organization (CROs) & Pharmaceutical Companies.

BE study Centre
Two weeks certificate course on Biopharmaceutical analysis under the purview of bioequivalence study, toxicity study and clinical trials

Bilcare Academy
Post Graduate Diploma in Clinical Research

Bioinformatics Centre, University of Pune
Postgraduate Certificate Course in Clinical Research and Clinical Data Management' (CRCDM) 6 months (weekend course)

Catalyst Clinical Services Pvt. Ltd.
Professional Diploma in Clinical Research (PDCR®)
ACCR TM
Advance Certificate Program(S) in Clinical Research
GCP Training Workshops
Oncology Clinical Trials Training
Training Program for Clinical Investigators and Site Personnel
Training Program for Ethics Committee Members
Clinical QuestTM
21 CFR Part 11 Training

Centre for Advencement in Health Sciences
Post Graduate Diploma in Clinco-Regulatory and Patents
Master of Science in Clinical Research
Master of Science in Pharmacology
Post Graduate Diploma in Clinical Data Management

Cliniminds
Integrated Post Graduate Diploma in Clinical Research & Pharmacovigilance
Advanced Post Graduate Program in Clinical Research
Certificate Program in Clinical Research
Post Graduate Program in Pharmacovigilance
Post Graduate Program in Conducting & Managing Bioequivalence & Bioavailability Studies
Post Graduate Program in the Conducting & Managing Clinical Trials for Cancer Patients
Post Graduate Program in Clinical Data Management
Post Graduate Program for Investigators & Site Personnel
Post Graduate Program for Monitoring
Advanced Post Graduate Program in Clinical Research
Post Graduate Program in Clinical Trials Management
Certificate Program in Clinical Research for Nurses
Post Graduate Program in Quality Assurance in Clinical Research
Post Graduate Program in Basics of Biostatistics
ICH GCP Certificate Program in Clinical Research for Medical Practitioners
Post Graduate Program in Pharmacovigilance
Integrated Post Graduate Diploma in Clinical Research & Pharmacovigilance
Post Graduate Diploma in Medical and Scientific Content Writing

Clinotek India
Advanced Diploma in Clinical Research, Regulatory Affairs and Clinical Data Management with SAS Base –Classroom
Diploma in Clinical Research, Regulatory Affairs and Clinical Data Management - Online

CRO Careers

Professional Certification in Clinical Research and Management (PCCRM)

CREMA – Clinical Research Education and Management Academy
Advanced Postgraduate Diploma in Clinical Research Management (APGDCRM) – Full Time
Post Graduate Diploma in Clinical Research (PGDCR) – Part Time
Post Graduate Diploma in Clinical Data Management (PGDCDM)– Part Time
Post Graduate Diploma in Pharmacovigilance (PGDPhV) – Part Time

Integrity Healthcare Services

One year Online Diploma in Clinical Research

Goa University
Post Graduate in Clinical Research and Clinical Data Management
Advanced Post Graduate Diploma in Clinical Monitoring & Site Management with hands on training on ORACLE RDC software
Advanced Post Graduate Diploma in Pharmacovigilance with hands on training on ORACLE AERS
Advanced Post Graduate Diploma in Pharmacovigilance
Advanced Post Graduate Diploma in Medical Writing & Scientific Publications

Bioinnovat Research Services in Collaboration with Pune University and Goa University
Post Graduate Certificate in Clinical Research
Advanced Post Graduate Diploma in Clinical Monitoring & site Management
Advanced Post Graduate Diploma in Medical Writing and Scientific Publications
Advanced Post Graduate Diploma in Pharmacovigilance
Advanced Post Graduate Diploma in Clinical Data Management with SAS Programming

IBI Biosolutions
Advanced Diploma in Clinical Research (ADCR)

HICR (Hindustan Institute of Clinical Research)
Post Graduate Diploma in Clinical Research

Innovative Centre for Clinical Research
Distance learning / correspondence Courses
Post Graduate Diploma in Clinical Trials, Research and Administration
Post Graduate Diploma in Clinical Research & Clinical Data Management (ADCRCDM)
Post Graduate Diploma in Pharmacovigilance (PGDPHv)
Advance Diploma in Clinical Research (ADCR)
Advance Diploma in Clinical Data Management (ADCDM)
Advance Diploma in Clinical Research & Clinical Data Management (ADCRCDM)

Full time/Part time Course
Advance Diploma in Clinical Research & Clinical Data Management
PG Diploma in Clinical Research & Clinical Data Management (ADCRCDM)
Post Graduate Diploma in Clinical Research & Clinical Data Management (PGDCRCDM)
Post Graduate Diploma in Pharmacovigilance (PGDPHv)
Advance Diploma in Clinical Data Management
Advance Diploma in SAS (ADSAS)

Project / Training in Clinical Data Management / SAS / Bioinformatics

Institute of Advanced Pharmaceutical Studies
Post Graduate Diploma in Clinical Research Management and Regulatory Affairs Certificate Course in Clinical Research
Certificate Course in Clinical Data Management
Certificate Course in Pharmacovigilance and Medical Affairs Clinical Data Management
Correspondence Certificate Course in Clinical Research and Clinical Data Management

ICRI-Institute of Clinical Research (India)
Full Time :
M.Sc. in Clinical Research
M.Sc. in Clinical Research Management
Advanced Post Graduate Diploma in Clinical research

Part Time:
PG Diploma in Clinical Research
PG Diploma in Healthcare Management
Executive MBA in Healthcare Management
PG Diploma in Clinical Trial Management
PG Diploma in Clinical Data Management
PG Diploma in Pharmacovigilance
PG Certificate in Clinical Research for Nurses
Certificate in Clinical Research for Nurses
PG Diploma in Clinical Research Specialization in Business Development
PG Diploma in Clinical Research Specialization in Quality Assurance and Audit
Post Graduate Diploma in Regulatory Affairs


International Centre for Training in Clinical Research
Postgraduate Diploma with Training in Clinical Research
Post graduate Diploma in Clinical Research (Part Time)
Training on, Foundation of Clinical Research and GCP, Introduction & Principles of ICH GCP, Indian GCP, Role of IEC, Informed Consent Process, Investigator Responsibility, Sponsor Responsibility, Handling of Investigational Product, Safety Reporting, Investigator Brochure, Essential Documents

Lotus Clinical Research Academy
Principles & Practice of Clinical Research - HARVARD MEDICAL SCHOOL, USA
M.S. in Pharmaceutical Chemistry - The University of Kansas, USA
Certificate Course in Pharmacokinetics - The University of Kansas, USA
M Pharm in Clinical Research - Birla Institute of Technology, B.I.T, Mesra, Ranchi
Post Graduate Diploma in Bioanalytical Techniques - Birla Institute of Technology (B.I.T), Mesra, Ranchi
MBA in Health Care Services- Sikkim Manipal University
M Sc in Clinical Research & Regulatory Affairs - Sikkim Manipal University
Advanced PG Diploma in Clinical Data Management with Practical Training on ORACLE Clinical & ORACLE TMS software - Goa University
Advanced PG Diploma in Clinical Monitoring & Site Management with Practical Training on ORACLE RDC software - Goa University
Advanced PG Diploma in Pharmacovigilance with Practical training on ORACLE AERS software - Goa University
PG Certificate in Clinical Research & Data Management - Goa University
Advanced PG Diploma in Clinical Research
Advanced PG Diploma in Clinical Data Management
Certificate Course in Bioanalytical Techniques
PG Diploma in Clinical Research & Pharmacovigilance
Certificate Course for Clinical Research Associates

Reliance Institute of Life Sciences (RILS)
Young Clinical Professionals' Program (YCPP)
Advanced Diploma in Clinical Research

Sikkim Manipal Univeristy
Master of Science in Clinical Research & Regulatory Affairs (MScCRRA)

Symbiosis Centre for Health Science
Certificate in Clinical Research

St. Xavier's College, Mumbai
Diploma in Clinical Research

Shivrath Center of Excellence in Clinical Research
Post Graduate Diploma in Clinical Research (PGDCR)-One Year Full Time Course.
Post Graduate Diploma in Advance Clinical Research (PGDACR)-One Year Part Time Course.
Post Graduate Diploma in Clinical Trial Management (PGDCTM)-One Year Part Time Course.

The Manipal Education and Medical Group
Diploma in Clinical Research & Regulatory Affairs
Diploma in Clinical Research & BA-BE Studies

Vaatsalya Clinical
Provides customized training courses to meet client’s specific needs in the areas of - Good Clinical Practice (GCP), Validation, Clinical Quality Assurance, Clinical Trial Regulations (US, India, European etc.).

Vibgyor CRO
Six months part-time evening course : Evening & Weekend batch of Training Course in Clinical Research.

Xcellon Institute
PG Program in Healthcare Business
PG Diploma in Clinical Research
Certificate Course in Clinical Trial Monitoring
PG Diploma for Clinical Research Investigator
PG Diploma in Clinical Data Management
PG Diploma in Statistics for Clinical Research
Certificate Course in Project Management

Books for Medical Writing

• A - Z of Medical Writing by Tim Albert
  
• Are You Thinking of a Career in Regulatory Medical Writing? A How-to Guide on Getting Started by Deborah A. Early PhD MICR 
  
• Clinician's Guide to Medical Writing by Robert B. Taylor 
  
• Effective Writing for Health Professionals by MEGAN-JANE JOHNSTONE 
  
• Essentials of Writing Biomedical Research Papers by Mimi Zeiger 
  
• Grammar and Writing Skills for the Health Professional (Villemaire,Grammar and Writing Skills for the Health Professional) by Lorraine Villemaire and Doreen Villemaire
  
• Guidebook to Better Medical Writing by Robert L. Iles 
  
• How to Report Statistics in Medicine: Annotated Guidelines for Authors, Editors, and Reviewers by Thomas A. Lang and Michelle Secic
  
• Mastering Scientific and Medical Writing: A Self-help Guide by Silvia M. Rogers 
  
• Medical Writing 101: A Primer for Health Professionals by Arnold Melnick (Paperback - April 11, 2006)
  
• Medical Writing in Drug Development: A Practical Guide for Pharmaceutical Researchby Robert Bonk 
  
• Medical Writing: A Prescription for Clarity by Neville W. Goodman, Martin B. Edwards, and Andy Black 
  
• Popular Health & Medical Writing for Magazines: How to Turn Current Research & Trends into Salable Feature Articles by Anne Hart 
  
• Successful Scientific Writing Full Canadian binding: A Step-by-Step Guide for the Biological and Medical Sciences by Janice R. Matthews, John M. Bowen, and Robert W. Matthews 
  
• Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics by Linda Fossati Wood and MaryAnn Foote
  
• THE ACCIDENTAL MEDICAL WRITER: How We Became Successful Freelance Medical Writers. How You Can, Too. by Brian G. Bass and Cynthia L. Kryder MS CCC-Sp 
  
• The Complete Guide to Medical Writing by Mark C. Stuart 
  
• Writing for Professional Medical Publications by Laura Gater
  
• WRITING FOR PROFESSIONAL MEDICAL PUBLICATIONS by Laura Gater
  
• Writing, Speaking, and Communication Skills for Health Professionals by Ms. Stephanie Barnard, Mr Kirk T. Hughes, Ms. Deborah St. James, and Health Care Communication Group
  

Books for Sample Size Calculation and Biostatistics

• Sample Size Calculations in Clinical Research (Biostatistics, 11) by Shein-Chung Chow, Jun Shao, and Hansheng Wang 
  
• Sample Size Calculations in Clinical Research, Second Edition (Chapman & Hall/CRC Biostatistics Series) by Shein-Chung Chow, Jun Shao, and Hansheng Wang 
  
• Practical Handbook of Sample Size Guidelines for Clinical Trials by Jonathan J. Shuster
  
• CRC Handbook of Sample Size Guidelines for Clinical Trials by Jonathan J. Shuster
  
• Determining Sample Size: Balancing Power, Precision, and Practicality (Pocket Guides to Social Work Research Methods) by Patrick Dattalo
  
• Sample Size Tables for Clinical Studies by David Machin, Michael J. Campbell, Say-Beng Tan, and Sze-Huey Tan

• Adaptive Design Methods in Clinical Trials (Biostatistics) by Shein-Chung Chow and Mark Chang
  
• Basic & Clinical Biostatistics (LANGE Basic Science) by Beth Dawson, Robert Trapp, Beth Dawson, and Robert Trapp
  
• Clinical Epidemiology and Biostatistics (National Medical Series for Independent Study) by Rebecca G. Knapp and M. Clinton Miller
  
• Tutorials in Biostatistics, Statistical Methods in Clinical Studies (Volume 1) by Ralph B. D'Agostino
  
• Data and Safety Monitoring Committees in Clinical Trials (Chapman & Hall/Crc Biostatistics) by Jay Herson
  
• Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health) by Michael A. Proschan, K.K. Gordon Lan, and Janet Turk Wittes
  
• Clinical Trials: Design, Conduct, and Analysis (Monographs in Epidemiology and Biostatistics, Vol 8) by Curtis L. Meinert
  
• Clinical Biostatistics by Alvan R. Feinstein
  
• Design and Analysis of Clinical Trials with Time-to-Event Endpoints (Chapman & Hall/Crc Biostatistics Series) by Karl E. Peace
  
• Missing Data in Clinical Studies (Statistics in Practice) by Geert Molenberghs and Michael Kenward
  
• Biostatistics in Clinical Trials (Wiley Reference Series in Biostatistics) by Carol K. Redmond and Theodore Colton
  
• Advances in Clinical Trial Biostatistics by Nancy L. Geller
  
• Statistical Methods for Clinical Trials (Biostatistics) by Mark X. Norleans
  
• Introductory Biostatistics for the Health Sciences: Modern Applications Including Bootstrap (Wiley Series in Probability and Statistics) by Michael R. Chernick and Robert H. Friis
  
• Epidemiology and Biostatistics: An Introduction to Clinical Research by Bryan Kestenbaum
  
• Clinical Biostatistics: An Introduction to Evidence-Based Medicine by Graham Dunn
  
• Meta-Analysis of Controlled Clinical Trials (Statistics in Practice) by Anne Whitehead
  
• Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series) by Christopher Jennison and Bruce W. Turnbull
  
• Common Statistical Methods for Clinical Research with SAS Examples, Second Editionby Glenn A. Walker
  
• Introductory Biostatistics by Chap T. Le
  
• Data Monitoring in Clinical Trials: A Case Studies Approach by David L. DeMets, Curt D. Furberg, and Lawrence M. Friedman
  
• Statistical Monitoring of Clinical Trials: Fundamentals for Investigators by Lemuel A. Moyé
  
• Randomization in Clinical Trials: Theory and Practice (Wiley Series in Probability and Statistics) by William F. Rosenberger and John M. Lachin
  
• Statistics Applied to Clinical Trials by Ton J. Cleophas, Aeilko H. Zwinderman, Toine F. Cleophas, and Eugene P. Cleophas
  
• Bayesian Approaches to Clinical Trials and Health-Care Evaluation (Statistics in Practice) by David J. Spiegelhalter, Keith R. Abrams, and Jonathan P. Myles
  
• The Design and Analysis of Sequential Clinical Trials, 2.Rev.Ed. by John Whitehead
  
• Clinical Statistics: Introducing Clinical Trials, Survival Analysis, and Longitudinal Data Analysis (Jones and Bartlett Series in Mathematics) by Olga Korosteleva
  
• Design and Analysis of Quality of Life Studies in Clinical Trials (Interdisciplinary Statistics) by Diane L. Fairclough
  
• Handbook of Statistics in Clinical Oncology, Second Edition by John Crowley and Donna Pauler Ankerst
  
• Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics) by Steven Piantadosi
  
• Practical Handbook of Sample Size Guidelines for Clinical Trials by Jonathan J. Shuster
  
• Multiple Analyses in Clinical Trials: Fundamentals for Investigators (Statistics for Biology and Health) by Lemuel A. Moyé
  
• Intuitive Biostatistics by Harvey Motulsky
  
• Fundamentals of Biostatistics by Bernard Rosner
  
• Biostatistics, Second Edition: A Guide to Design, Analysis and Discovery. by Ronald N. Forthofer, Eun Sul Lee, and Mike Hernandez
  
• Principles of Biostatistics by Marcello Pagano and Kimberlee Gauvreau
  
• Basic & Clinical Biostatistics (LANGE Basic Science) by Beth Dawson, Robert Trapp, Beth Dawson, and Robert Trapp
  
• Biostatistics: The Bare Essentials 3/e (with SPSS) by Norman, Geoffrey Norman, and David Streiner
  
• High-Yield Biostatistics (High-Yield Series) by Anthony N Glaser
  
• Biostatistics for the Biological and Health Sciences with Statdisk by Marc M. Triola and Mario F. Triola
  
• Biostatistics, Student Solutions Manual: A Foundation for Analysis in the Health Sciences (Wiley Series in Probability and Statistics) by Wayne W. Daniel
  
• Primer of Biostatistics: Sixth Edition (Primer of Biostatistics (Glantz)(Paperback)) by Stanton Glantz
  
• Basic Biostatistics: Statistics for Public Health Practice by B. Burt Gerstman
  
• Introductory Applied Biostatistics by Sr., Ralph D'Agostino, Lisa Sullivan, and Alexa Beiser
  
• Regression Methods in Biostatistics: Linear, Logistic, Survival, and Repeated Measures Models (Statistics for Biology and Health) by Eric Vittinghoff, David V. Glidden, Stephen C. Shiboski, and Charles E. McCulloch
  
• Biostatistics: The Bare Essentials, Second Edition (Biostatistics: The Bare Essentials)by Geoffrey R. Norman and David L. Streiner
  
• An Introduction to Biostatistics by Thomas Glover and Kevin Mitchell
  
• Epidemiology, Biostatistics and Preventive Medicine: With STUDENT CONSULT Online Access by Dorothea Wild MD MPH Dr. Med, James F. Jekel MD MPH, David L. Katz MD MPH, and Joann G. Elmore MD MPH
  
• Biostatistics for the Health Sciences by R. Clifford Blair and Richard Taylor
  
• Biostatistics: A Methodology For the Health Sciences (Wiley Series in Probability and Statistics) by Gerald van Belle, Patrick J. Heagerty, Lloyd D. Fisher, and Thomas S. Lumley
  
• Easy Interpretation of Biostatistics: The Vital Link to Applying Evidence in Medical Decisions by Gail F. Dawson MD MS FAAEP
  
• Introductory Biostatistics for the Health Sciences: Modern Applications Including Bootstrap (Wiley Series in Probability and Statistics) by Michael R. Chernick and Robert H. Friis
  
• Statistics in Medicine, Second Edition by R. H. Riffenburgh
  
• Epidemiology, Biostatistics and Preventive Medicine by James F. Jekel MD MPH, David L. Katz MD MPH, and Joann G. Elmore MD MPH
  
• Biostatistics and Epidemiology: A Primer for Health and Biomedical Professionals by Sylvia Wassertheil-Smoller
  
• Elementary Bayesian Biostatistics (Chapman & Hall/CRC Biostatistics) by Lemuel A. Moyé
  
• Biostatistics: How It Works by Steve Selvin
  
• Biostatistical Analysis (5th Edition) by Jerrold H. Zar
  
• Study Guide to Epidemiology And Biostatistics (Study Guide to Epidemiology and Biostatistics) by J. Richard Hebel and Robert J. McCarter 
  

Some Books of Clinical Research

• Foundations of Clinical Research: Applications to Practice (3rd Edition) by Leslie Gross Portney and Mary P. Watkins 
  
• Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators by Judy Stone 
  
• Principles and Practice of Clinical Research, Second Edition (Principles & Practice of Clinical Research) by John I. Gallin and Frederick P Ognibene  
  
• Designing Clinical Research: An Epidemiologic Approach by Stephen B Hulley, Steven R Cummings, Warren S Browner, and Deborah G Grady 
  
• The CRC's Guide to Coordinating Clinical Research by Karen E. and Ph.D. Woodin
  
• Clinical Research: What It Is and How It Works by Lori A. Nesbitt
  
• The CRA's Guide to Monitoring Clinical Research :2nd Edition by Karen E. Woodin, Ph.D., John C. Schneider, and Sara Gambrill
  
• Fundamentals of Clinical Trials by Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets
  
• A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good
  
• A Step-By-Step Guide to Clinical Trials by Marilyn Mulay
  
• Principles and Practice of Clinical Trial Medicine by Richard Chin and Bruce Y Lee
  
• Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary by Ezekiel J. Emanuel, Robert A. Crouch, John D. Arras, and Jonathan D. Moreno
  
• An Introduction to Clinical Research by Catherine DeAngelis
  
• Clinical Research Coordinator Handbook by Deborrah Norris
  
• Clinical Trials - A Practical Guide to Design, Analysis, and Reporting by Duolao Wang and Ameet Bakhai
  
• Essentials of Clinical Research by Stephen P. Glasser
  
• Responsible Research: A Guide For Coordinator's by Carol A. Fedor, Philip A. Cola, and Christine Pierre
  
• Clinical Trials: A Practical Approach by Stuart J. Pocock
  
• Clinical Research for Health Professionals: A User-Friendly Guide by Mitchell Batavia
  
• Clinical Epidemiology: How to Do Clinical Practice Research (CLINICAL EPIDEMIOLOGY (SACKETT)) by R. Brian Haynes, David L Sackett, Gordon H Guyatt, and Peter Tugwell(Paperback - Sep 1, 2005)
  
• Clinical Research in Communicative Disorders: Principles and Strategies by M. N. Hegde (Hardcover - Aug 2003)
  
• Methodological Issues & Strategies in Clinical Research by Alan E. Kazdin
  
• Evaluating Clinical Research: All that glitters is not gold by Bengt D. Furberg and Curt D. Furberg
  
• Clinical Research Methods in Speech-language Pathology And Audiology by Mary Pannbacker, Norman J. Lass David Irwin
  
• Translational and Experimental Clinical Research by Daniel P Schuster, William J Powers, Mario Castro, and William Shannon
  
• Research: the Validation of Clinical Practice by Otto D. Payton
  
• Designing Clinical Research 2ND Edition by Stephen B Hulley
  
• Handbook For Clinical Investigators by Christopher Kirkpatrick
  
• The Emerging Markets of Clinical Research by Sara Gambrill and Steve Zisson
  
• Research Methods in Community Medicine: Surveys, Epidemiological Research, Programme Evaluation, Clinical Trials by Joseph Abramson and Z. H. Abramson
  
• Careers in Clinical Research: Obstacles and Opportunities by Committee on Addressing Career Paths for Clinical Research, Division of Health Sciences Policy, William N. Kelley, and Mark A. Randolph
  
• The Investigator's Guide to Clinical Research (Third Edition) by David Ginsberg
  
• Clinical Research Methodology and Evidence-based Medicine: The Basics by Ajit N. Babu
  
• Clinical Research Methods for Surgeons by David F. Penson
  
• The Oxford Textbook of Clinical Research Ethics by Ezekiel J. Emanuel, Christine Grady, Robert A. Crouch, and Reidar Lie
  
• Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (Critical Issues in Health and Medicine) by Jill A. Fisher
  
• Ethics and Regulation of Clinical Research: Second Edition by Robert J. Levine
  
• Good Clinical Practice: Standard Operating Procedures for Clinical Researchers by Josef Kolman, Paul Meng, and Graeme Scott
  
• Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance by Fay A. Rozovsky JD MPH and Rodney K. Adams
  
• The Lancet Handbook of Essential Concepts in Clinical Research (The Lancet Handbooks) by Kenneth Schulz PhD MBA and David A. Grimes MD
  
• Handbook of Clinical Research Law and Compliance by John E. Steiner
  
• Writing Clinical Research Protocols: Ethical Considerations by Evan DeRenzo and Joel Moss
  
• Exploitation and Developing Countries: The Ethics of Clinical Research by Jennifer S. Hawkins and Ezekiel J. Emanuel
  
• Publishing and Presenting Clinical Research, Second Edition by Warren S Browner
  
• Double Standards in Medical Research in Developing Countries (Cambridge Law, Medicine and Ethics) by Ruth Macklin
• Wiley Encyclopedia of Clinical Trials, 4 Volume Set by Ralph B. D'Agostino, Lisa Sullivan, and Joseph Massaro 

Clinical Research Education/Training Institutions in India

Academy for Clinical Excellence 
Aceas Clinical Research 
BE study Centre 
Bilcare Academy 
Bioinformatics Centre, University of Pune
Catalyst Clinical Services Pvt. Ltd. 
Centre for Advencement in Health Sciences 
Cliniminds 
Clinotek India
CREMA 
CRO Careers
Fermish Clinical Technologies Pvt Ltd 
Goa University 
HICR (Hindustan Insititute of Clinical Research)
IBI Biosolutions
Innovative Centre for Clinical Research 
Institute of Advanced Pharmaceutical Studies 
Institute of Clinical Research (India)
International centre for training in clinical research 
Lotus Clinical Research Academy 
Nexus Institute for Clinical Research 
Reliance Clinical Research Services 
Reliance Institute of Life Sciences (RILS) 
Shivrath Center of Excellence in Clinical Research 
Sikkim Manipal Univeristy
St. Xavier's College, Mumbai 
Symbiosis centre for HealthScience 
The Manipal Education and Medical Group 
Vaatsalya Clinical
Vibgyor CRO 
Xcellon Institute

Clinical Research Organizations in India

Abbott
Accutest Research Laboratories
Ace Biomed
Actimus Biosciences
Adroit Insights Lifesciences
Advanced Clinical Research
Advinus Therapeutics
Alquest, Inc.
AnaZeal Analyticals & Research
Apotex Research
Apothecaries
Alembic Research Centre
Asian Clinical Trials
Asiatic Clinical Research
AstraZeneca India
BA Rresearch India
BE Study Centre
Bharat Biotech International
Bilcare Research
Bioserve India
Boehringer Ingelheim India
Bristol Myers Squibb
Cadila Pharmaceuticals
Catalyst Clinical Services
Chembiotek
Chiltern Internation
Clinigene International
Clininvent Research
CliniReach Clinical services
CliniRx
ClinTec (India) International
Clintech Research India
Clintrac International
Clinworld
Covance Inc.
Criterium
DO Research
Dabur
Dr. Reddys
Eisai
Eli Lilly
ETI Karle Research
Excel Lifesciences
Fermish Clinical Technologies
Fortis Clinical Research Ltd.
GE Clinical Research
Glaxo SmithKline
Gleneagles CRC
Glenmark
Global Spectra Clinical Research
GVK Biosciences
Himalaya
Icon
Igate Clinical Research
Intas Pharma

Integrity Healthcare Service
Intox
Irl - Synexus
Jai Research Foundation
Johnson & Johnson
Jubilant Clinsys
Kendle
Khandelwal Laboratories
Lal path Labs
Lamda
Lotus
Lupin Labs
Manipal Acunova
Matrix Labs
Max Healthcare
Metropolis
Micro Therpeutics
Neeman Medical
Nexus
Nicholas Piramal
Novartis
Novo Nordisk
Odyssey
Omnicare
Orchid Pharma
Panacea
Paragon Bio
Paraxel - Apex
Pfizer
Pharmanet
PharmaOlam
Pliva
PPD
PRA International
Progressive Lifesciences
Quartesian
Quest
Quintiles
Raj Biotech
Ranbaxy
Reliance Clinical Research Services
Rheoscience
Roche Diagnostics India
Sami Labs
Sanofi-Aventis India
Schering Plough
Semlar Research Center
Sephmer Sciences International
Shanta Biotechnics
Sipra Labs
SIRO Clinpharm
Spectrum Clinical Research
Star Clinical Research Org
Strides Arcolab
Suven Lifesciences
Synchron
TCG Lifesciences
Translation Medicine India
Torrent Pharma
Trident Clinical Research
Trident Lifesciences
Triesta
USV Pharma
Vedic Lifesciences
Veeda Clinical Research
Vibgyor Scientific Research
Vimta Labs
Wellquest
Wyeth
Zydus Cadilla
Xcelris Labs

Medical Writing in Clinical Research

Medical Writing is the activity of producing scientific documentation by a specialized writer. It is that type of writing which requires huge amount of technical knowledge in relevant matter. The writer should have good knowledge of medical terminology as well as writing skills. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe clinical research results, product use, and other medical information. The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure. Medical writing as a function became established in the clinical research world because the pharmaceutical industry which recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.            

Medical writing in clinical research can be classified as either regulatory medical writing or educational medical writing. Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. Regulatory documents can be huge and formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures, and summary documents. Educational medical writing means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. There are several professional organizations represent medical writers around the world. Some of them are American Medical Writers Association (AMWA), European Medical Writers Association (EMWA) and Indian Medical Writers Association (IMWA). These organizations provide a forum where medical writers meet and share knowledge and experience. They promote professional development and standards of documentation excellence, and help writers find career opportunities. All these organizations offer fundamental medical writing training.

Clinical Research in India

Clinical research in India is developing day by day, having number of pharmaceutical or biotechnological companies. This pharmaceutical industries works on researching new drugs not only for tropical diseases, but also for universal diseases such as cancer, aids, diabetes, etc. Since the western medical fraternity is poor in researching numerous Indian diseases, they are attracted to build their establishment in India and competing in the global market. There are certain Contract Research Organizations or Clinical Research Organizations (CROs) which offer their clients with many services which include development of the product, formulation and ultimate production in spite of sponsor.   

A wide range of outsourcing services related to pharmaceutical research are offered by numerous Indian CROs to their clients to aid in the medical device research, drugs and development process. That means a legal person or a corporation as an independent contractor takes the contract from a client along with the sponsor designs some rules, investigates, evaluate reports, prepare materials and submits to FDA (Food and drug administration) or their clients. The number of services offered includes: development of the product, formulation of the product and manufacturing of the product.

For medical research, Clinical Research Organizations conducts clinical trials to provide safety and effective data for new drugs. Once acceptable information is gathered about the quality of the product and its clinical and non-clinical safety and approval from health authority or ethics committee of India is granted this trials takes place. Professionals of these research organizations initially hire or enroll patients and/or volunteers depending on the stage of development and type of the product and then they compare the new product with the ongoing prescribed treatment by performing large scale and final studies in patients.

There are number of medical research centers or CROs in India whose main motive behind the clinical research is to provide quality clinical research support to the biotechnical and pharmaceutical industries. This will lead to research of novel drug delivery system; evolve innovative therapies, development of new chemical entities, and taking care keeping safety of patient. There are numerous clinical research organizations which are providing superb scientific expertise, benchmark ethical practices and quality commitment, and caring out clinical research development of new novel therapies and molecular entities much faster also with high level of accuracy. So there is many clinical research organizations performing clinical trials at lower cost compared to wester countries CROs, within lesser time to complete the medical project. Even there are some institutes in India which works on researches for new generic and special drugs and new technology of medical treatments; they are AIIMS (e.g. All India Institute of Medical Science, New Delhi), the research materials are outsourced by many biotechnical and pharmaceutical companies of India and they finally produces drugs.