Prospectus

cliniminds
Academy for Clinical Research Training & Management
TM
An ISO 9001:2000
An ISO 9001:2000 Certified Academy Certified Academy
Join $20 billion Global Clinical Research Industry

Education & Training Programs to Facilitate Career in Clinical Research & Continuous Clinical Research
Professional Education
Why Career in Clinical Research?

 Fastest growing segment in the healthcare / pharmaceutical industry globally
 Excellent Opportunity to Develop Combination of Technical and Management Skill Development
 Part of the Global Growth Opportunity
 Wider Job Horizon
 Rapidly Growing Opportunities… and growing (internal and external)
 Attractive Compensation and future growth
 Higher Job Satisfaction
 Continuous Training Opportunities
 International Working and Training Opportunities
Cliniminds Offers High Quality Professional Training Programs in

Clinical Research
Clinical Research today offers most attractive career opportunities to the graduates and post graduates
MD, MBBS, BDS, BAMS, BHMS, BUMS, BPT, Biochemistry, Biotechnology, Microbiology, Pharmacy,
Pharmacology Life Sciences and other allied life sciences streams.
By 2012, 50,000 new professionals will be required in the clinical research sector, which is currently
growing at 40% per annum. By 2012, Indian clinical research industry would be over $2 billion (Rs.10,000
crores). At present, industry needs over 15,000 clinical trial professionals per annum. Globally over
200,000 new trained professionals would be required.
There are over 160 companies involved in the clinical research business in India, including all leading
multinational and Indian pharmaceutical and biotechnology companies, Contract Research Organizations
and several hospitals.
In addition to the contribution which you will be making towards new drug development, clinical research
sector also offers attractive salaries, continuous growth in annual salaries and professional growth
opportunities both internally and externally. Most employers offer continuous training opportunities within
India and abroad for their employees.
Cliniminds - Academy for Clinical Research Training & Management offers wide range of full time, part
time, class room, online & distance learning certificate / diploma programs, workshops & seminars in the
fields of clinical research. Programs have been designed both for fresh graduates/post graduates and
working professionals to equip them to grow professionally in this burgeoning field of clinical research.
Good Clinical Practice (GCP) regulations and guidelines govern clinical trials, and a thorough knowledge
of guidelines and regulations at every stage of the clinical trial process is essential. Cliniminds can help
you achieve the level of expertise required through our user-friendly and cost-effective training programs -
whether you need to train for a career in clinical trials, or update your knowledge with current information.
Cliniminds is an innovative training company providing a wide range of clinical research related training
solutions to the students, pharmaceutical companies, CROs and healthcare companies in India and other
parts of the world including organizations like NIH, Merck, Novartis, Ranbaxy, Biocon and other leading
names.
Cliniminds was established in year 2004, by a group of professionals from Clinical Research,
Pharmaceutical industry and Healthcare industry with rich and varied experience at top levels. Company
was set up with the objective to offer training solutions in the field of clinical research, pharmaceuticals
and healthcare services.

cliniminds
TM
An ISO 9001:2000
Types of Jobs / Positions

 Clinical Research Coordinators / Site Coordinators
 Clinical Monitors / CRAs
 Drug Safety Personnel
 Project Personnel
 Medical Monitors
 Medical Writers
 Quality Control / Assurance Personnel
 Data Management Personnel
 Statisticians
 Scientists
 Lab Personnel
 Management & Support Personnel
Salaries
Starting salaries range between Rs.1.6 to Rs.3 lakhs per annum, depending upon the key qualification(s),
experience, performance, and employer.
Key Features of Cliniminds Programs

 India’s Largest Classroom, Online E-learning / Distance Learning Program
 Option of LIVE VIDEO CONFERENCE BASED CONTACT PROGRAMS
 Contact Programs / Workshops
 Best Study Material
 Excellent Placement Program
 Affordable Fee & Easy Installments
 Credit Cards Accepted
 Online/E-Learning Programs & Online Exams
 Best Faculty in Industry - Fulltime & Visiting
 Bank Loans for Classroom Programs
Placements
100% placement support in place for Classroom students. Students of Online/Distance Learning are also
provide placement assistance. Excellent placements with attractive salaries in the last 4 years.
Placements have been done in the following companies:
 LG Lifesciences
 Dabur
 Fresenius Kabi
 Green Point Technologies
 Max Neeman Medical International
 Nexus CRO
 CliniRx
 Ranbaxy Group
 Apollo
 Max Healthcare
 Nester Pharma
 Johnson & Johnson

cliniminds
TM
An ISO 9001:2000
Teaching & Training Techniques

Practical Training support is provided to the students in CROs and pharmaceutical companies, in the
simulated environment. Modern training and educational methods are used to provide industry oriented
programs.
Certification & Accreditation

 All Cliniminds Programs are certified and accredited by the Pharmaceutical Society of India.
 Cliniminds is an ISO 9001:2000 Certified Academy
Industry Workshops
Cliniminds conducts workshops on number of different aspects of clinical research, viz. ICH GCP
Workshop on Clinical Research; Quality Assurance in Clinical Research; Pharmacovigilance in Clinical
Research; Clinical Trials Monitoring and number of other areas. These workshops help Cliniminds in
networking with the senior professionals in the industry.
Library Facilities
Cliniminds has extensive collection of clinical research and related books in the library for the students.
Information Technology
All Cliniminds centres have computers with wifi internet connections which could be used by the students
for the research and reference purposes.
Study Material
Cliniminds provides all students with the world class copyrighted study material. Study material consists
of notes, presentations and other reference books.
Online Learning System

All students of Cliniminds have access to the State-of-the-art Online Learning System. Students could log
in to Online Learning System at any time and access the study material from any part of the world at their
convenience.
Indian Clinical Research Industry

 2002 Industry Spending on CRO Services and Investigator Grants $30 million
 Market Size in 2005-06 $200 million
 Estimated Market Size in 2007 $450 million
 Estimated Market Size in 2009 $600 million
 2012 Projected Industry Spending on CRO Services and Investigator Grants $2 billion
 Number of CROs - current 100
 Number of MNC & Indian pharmacos in Clinical Research 60
 Clinical Research Market Growth (CAGR) 40%
 Full time & Site Staff Required in 2010/11 15,000
 New Protocols received by Indian Regulator everyday 20
 Patients / Subjects Required in 2010/11 120,000
 Over 3,000 new Certified Investigators will be required in 2009 and over 12,000 by 2012

cliniminds
TM
An ISO 9001:2000
Key Cities in India for Clinical Research

 Delhi & NCR Region
 Mumbai
 Pune
 Ahmedabad
 Vadodara
 Hyderabad
 Bangalore
 Chennai
 Chandigarh
More and more new centres are coming up in the different parts of the country.
India Hub of Global Clinical Research

 India is one of the top 3 countries where companies plan to spend the most R&D dollars over the
next 3 years.
 Favoured destination ahead of countries like Israel, Philippines, Canada, China, Ireland & Russia
in terms of Overall Climate (Gartner Report, January 2003)
 Powerhouse in R&D (GVK Wyeth R&D deal is a good indicator of this)
 Over 60 CROs offer Phase I to IV trials complying with ICH-GCP guidelines.
 Over US$500 million FDI expected in the next 18 months
 With 150 hospitals serving as sites for clinical trials, India is emerging as one of the fastest
recruiter of subjects across the world.
 India has some of the top medical/scientific universities in Asia
 The clinical community is populated with English speaking, western-trained graduates
 Sophisticated technological infrastructure 100 million plus English speaking people (Largest
outside US)
 Over 2 million science post graduates and increasing
 Large pool of treatment naïve patients from multiethnic and multiracial backgrounds
 Better patient recruitment, retention and compliance
 Participants generally benefit, as the trials conducted in India, mostly in phase II - IV, provide
improved care and cost savings as procedures and drugs are provided at no charge.
 Cost effective operations
 Higher GMP/GLP/GCP Compliance
 Maximum number of approved GMP plants outside USA
 Excellent quality management, technology and infrastructure
 Increasing presence of all pharma majors, CROs & also in-house CROs set up by leading
pharma companies
 Strong IT industry & availability of IT skilled manpower
 USFDA has set up office in India – this shows India’s importance in the global clinical research
and pharma space

cliniminds
TM
An ISO 9001:2000
Key Companies in Clinical Research in India

 Abbot, Mumbai  Chiron, Mumbai
 Astra Zeneca Pharma India Ltd, Bangalore  Astra Zeneca Foundation, Bangalore
 Aventis Pasteur, Delhi  Pfizer Ltd, Mumbai
 Pfizer Biometrics, Mumbai  Altana (Zydus), Mumbai
 Eli Lilly, Delhi  Boston Scientific, Delhi
 Hospira, Delhi  Merck, Delhi
 Sanofi Aventis Syntho Lab, Mumbai  GSK, Glaxo Smithkline Pharmaceuticals
 Novartis Pharma, Delhi  L d M Mumbai
Roche, b i
 Sandoz, Mumbai  Wyeth, Mumbai
 BMS, Mumbai  Novo Nordisk, Bangalore
 Lundbeck, Bangalore  Eisai Pharmaceuticals, Mumbai
 LG Life Sciences, Delhi  Bayer, Mumbai
 GE, Delhi  Johnson & Johnson, Jansenn Cilag,
 Cordi Baxter, Delhi  M b i
BD Biosciences, Delhi
 Bharat Biotech, Hyderabad  Bharat Serum, Mumbai
 Cadila Pharmaceuticals  Cipla, Mumbai
 Emcure, Pune  Fulford India Mumbai
 Indus Biotherapeutics, Ahmedabad  IPCA, Mumbai
 Shreya Biotech,Pune  Shantha Biotechnics Pvt. Ltd. Hyderabad
 Sun Pharma, Mumbai  Torrent Pharmaceutical Ltd, Gandhi nagar
 USV Ltd. Mumbai  Wockhardt, Mumbai
 Zydus Cadilla, Ahmedabad  Biocon, Bangalore
 Cadila Pharmaceuticals, Ahmedabad  Intas Pharmaceuticals Ltd., Ahmedabad
 Glenmark Pharmaceuticals Ltd., Mumbai  Himalaya Drugs ,Bangalore
 Lupin Ltd., Pune  Nicholas Piramal, Mumbai
 Panacea Biotech, Delhi  Ranbaxy Research Laboratories, Gurgaon
 Serum Institute of India, Pune  Torrent, Ahmedabad
 Quintiles, Ahmadabad / Bangalore  Max Neeman Medical
 Synchron, Ahmedabad /Bangalore  Lambda, Ahmedabad
 Genpact, Delhi/Bangalore  Siro Clinpharm, Mumbai
 I-Gate, Mumbai  Reliance Clinical Services, Mumbai
 PPD, Mumbai  Onmnicare, Bangalore
 ICON, Bangalore  Clin Trac, Bangalore
 PharmaNet, Bangalore  Pharm-Olam, Bangalore
 Lotus Labs, Bangalore  Vimta, Hyderabad
 GVK, Hyderabad  BioServe Clinical Research, Hyderabad
 Apothecaries, Delhi  Kendle, Delhi/Gurgaon
 Bioassay, Baroda  Clinworld, Bangalore
 Perinclinical, Mumbai  Quest Life Sciences
 Asian Clinical Trials  MTR, Chennai
 Pliva  Apollo

cliniminds
TM
An ISO 9001:2000
Cliniminds Clinical Research Programs

1. Post Graduate Diploma in Clinical Trials Management
2. Integrated Post Graduate Diploma in Clinical Research & Pharmacovigilance
3. Advanced Post Graduate Diploma in Clinical Research
4. Diploma in Clinical Research
5. Post Graduate Diploma in Pharmacovigilance
6. Post Graduate Diploma in Clinical Data Management & SAS
7. Post Graduate Diploma in Regulatory Affairs
8. Post Graduate Diploma in Medical and Scientific Content Writing
9. Post Graduate Diploma in Clinical Research for Nurses
10. Post Graduate Diploma in Biostatistics
11. Post Graduate Diploma in cGMP – Good Manufacturing Practices
12. Post Graduate Diploma in Patents & IPRs
13. Certificate Program in Clinical Trials Auditing & Inspection
14. ICH GCP Certificate Program in Clinical Research For Medical Practitioners
15. Certificate Program in Conducting & Managing Bioequivalence & Bioavailability Studies
16. Certificate Program in Quality Assurance in Clinical Research
17. Certificate Program in Clinical Trial Regulations & GCP in Europe & U.K.
18. Certificate Program in Conducting & Managing Clinical Trials for Cancer Patients
19. Certificate Program for Clinical Trial Investigators & Site Personnel
20. Certificate Program in Monitoring of Clinical Trials
21. Certificate Program in Clinical Research for Medical Devices

cliniminds
TM
An ISO 9001:2000
Post Graduate Diploma in Clinical Trials Management

Mode : Class Room
Distance/Online Learning
Duration : Classroom: One Year
Distance / E-Learning: One Year
Classroom Locations : Delhi, Bangalore, Hyderabad, Kerala, Bhopal
Eligibility : MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate
Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Biochemistry,
Microbiology, Biotechnology and all professionals working with Pharmaceutical companies,
CROs and hospitals.
Methodology : Weekend Classroom Contact Program; Printed Training Modules; Online Learning System;
Workshops.
Examination : Online MCQs, Exercises, Classroom exams & Project work.
Certificate : Certificate would be awarded upon successful completion of the program. Program is certified
& Accredited by the Pharmaceutical Society of India.
Job Assistance : Placement support would be provided to the successful classroom candidates. CVs of
successful candidates would be forwarded to CROs Hospitals and Pharmaceutical companies and,
Interviews would be organized. Limited placement support would also be provided to
Distance/Online Learning students.
Fee : Please refer website or enclosed Fee schedule.
Fee Payment : Fee Payable by Cash, Cheque / Bank draft in the name of ‘TENET HEALTH EDUTECH
PVT. LTD.’, payable at Delhi. Fee can also be deposited in company bank account. We also
accept Credit/Debit Cards.
Loan Facility : HDFC Bank – for classroom programs only
Program Details : The program would cover:
 Clinical Research Introduction & Terminology

 Healthcare Management Issues
 Introduction to Pharmaceutical Industry & Global Challenges
 Global Clinical Research Environment & Opportunities
 Regulatory Affairs
 Principles of Pharmacology & Drug Discovery & Development
 Roles & Responsibilities of Key Stakeholders
 Preparations & Planning for Clinical Trials
 Essential Documentation in Clinical Research & Regulatory Submissions
 Clinical Trials Project Planning & Management
 Study Start up Process
 Clinical Monitoring Essentials
 Compliance, Auditing & Quality Control in Clinical Research
 Clinical Data Management, Biostatistics, Analysis & Reporting
 Pharmacovigilance
 Bioavailability and Bioequivalence Studies
 Management of Cancer Clinical Trials
 Organizational Behavior & Human Resource Management
 Financial Management

cliniminds
TM
An ISO 9001:2000
Course Objectives
 To provide a comprehensive introduction to the clinical research process, conduct & management of clinical trials.
 Learn the skills, knowledge and competencies of a candidate for the Clinical Research Associate and other key positions.
 Become more familiar with roles/jobs as part of the study team.
 Extensive Knowledge & application in different aspect s of Clinical Research.

cliniminds
TM
An ISO 9001:2000
Integrated Post Graduate Diploma in Clinical Research & Pharmacovigilance

The objective of this program is to provide complete understanding of the clinical research and pharmacovigilance process and to
provide working knowledge to the students which would enable them to work in the industry with minimal training.
In the first phase we would provide a comprehensive practical knowledge to the clinical research processes, drug development
process, regulatory affairs, essential documentation, roles and responsibilities, ethics, monitoring, conduct and management of trials
and various other related issues.
In the second phase extensive training on Pharmacovigilance (PV) is provided. PV is the pharmacological science relating to the
detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.
In general terms, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from
healthcare providers and patients on the adverse effects of medications, biological products, herbals and traditional medicines with a
view to:
 Identifying new information about hazards associated with medicines

 Preventing harm to patients.
Mode : Class Room – Weekend

Duration : Classroom: Six months
Distance / E-Learning: Eleven months
Classroom Locations : Delhi, Bangalore, Hyderabad, Kerala
Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry,
CROs and hospitals.
Workshops.
PVT. LTD.’ payable at Delhi. Fee can also be deposited in company bank account. We also accept
Credit/Debit Cards.
Loan Facility : HDFC Bank – for classroom programs.
 Clinical Research Introduction


cliniminds
TM
An ISO 9001:2000

 Study Start Up Process
 General Overview of Pharmacovigilance
 Medical Dictionary for Drug Regulatory Activities MedDRA
 Regulatory Aspects in Pharmacovigilance
 Diagnosis And Management of Adverse Drug Reactions
 Medical Evaluation of Adverse Events
 Quality System in Pharmacovigilance
 Expedited Reporting Requirements
 Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
 Pharmacovigilance Database And Signal Detection Tools
 Risk Assessment, Evaluation And Management
 EudraVigilance
 Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting
Course Objectives
 To provide a comprehensive introduction to the clinical research process.

 Learn the skills, knowledge and competencies of a candidate for the Clinical Research Associate and pharmacovigilance jobs.
 Basic concepts, importance of Pharmacovigilance and Global Pharmacovigilance regulations.
 Practical aspects of important Pharmacovigilance activities as per the global standards like medical evaluation, casualty
assessment, expectedness assessment, case narratives, MedDRA, case processing preparation of safety report etc.

cliniminds
TM
An ISO 9001:2000
Advanced Post Graduate Diploma in Clinical Research

Mode : Class Room
Distance / E-Learning: Eleven months
CROs and hospitals.
Workshops.
Interviews would be organized. Limited placement support would also be provide to
Credit/Debit Cards.
Loan Facility : HDFC Bank - for classroom programs

Course Objectives

 Learn the skills, knowledge and competencies of a candidate for the Clinical Research Associate / Clinical Research
Coordinator position.

cliniminds
TM
An ISO 9001:2000
Diploma in Clinical Research

Mode : Distance/Online Learning
Duration : Six months
CROs and hospitals.
Methodology : Printed Training Modules; Online Learning System; Workshops.
Examination : Online MCQs, Exercises & Project work.
Credit/Debit Cards.
Program Details : This is a foundation educational program, designed for all the candidates aspiring to work in
the field of clinical research or allied professions like central labs. The program provides complete
overview and practical environment in the field of clinical research. The program would allow
candidates to upgrade their knowledge about ICH GCP Guidelines, regulatory issues and other
major aspects of clinical trials management. Select important topics from the following groups
would be covered in the program:

Course Objectives


cliniminds
TM
An ISO 9001:2000
Post Graduate Diploma in Pharmacovigilance

CROs and hospitals.
Credit/Debit Cards.
Program Details : This is a continuing training / educational program designed to provide a practical knowledge
for the, investigators, clinical research professionals, other pharmaceutical industry professionals,
including sales and marketing personnel and the students of pharmacy and other life science
stream. The program would cover:
 Introduction to Clinical Research & Phases in Clinical Research

 Principles of Good Clinical Practices - ICH GCP
 Medical Dictionary for Drug Regulatory Activities MedDRA
 Diagnosis And Management of Adverse Drug Reactions
 Medical Evaluation of Adverse Events
 Quality System in Pharmacovigilance
 Expedited Reporting Requirments
 Periodic Safety Update Reports (PSUR,s) For Marketed Drugs (ICH E2C)
 Pharmacovigilance Database And Signal Detection Tools
 Risk Assessment, Evaluation And Management
Course Objectives
 Candidate should able to understand the.

 Basic concepts, importance of Pharmacovigilance and Global Pharmacovigilance regulations.
 Practical aspects of important Pharmacovigilance activities as per the global standards like medical evaluation, casualty
assessment, expectedness assessment, case narratives, MedDRA, case processing preparation of safety report etc.

cliniminds
TM
An ISO 9001:2000
Post Graduate Diploma in Clinical Data Management & SAS

Mode : Class Room
Distance / E-Learning: Six months
CROs and hospitals.
Workshops.
Credit/Debit Cards.
Loan Facility : HDFC Bank – for classroom programs only.
Program Details : This course is designed to provide trainees with a working knowledge of the management of
clinical data used in clinical trials and other projects, leading to an academic and professional
qualification for Clinical Data Management (CDM). Development of the course involves
extensive consultation with the industry. The course is suitable for health information managers,
data managers and other health professionals working with, or planning to work with, clinical data
and other health databases. The program provides those attending a stimulating and enjoyable
opportunity to develop both as individuals and as professionals, increasing their efficiency,
effectiveness, capacity and competence, and building on the skills and knowledge gained from
valuable work experience. It also represents a great chance to meet others from different parts of
the industry to share experiences and build up a network of friends and contacts. Key topics
covered in the program are:
Data Management
 Introduction to Data Management
 Study Set Up
 CRF Design Considerations
 Data Entry, Remote Data Entry
 Identifying and Managing Discrepancies
 Medical Coding
 Database Closure
 Clinical Database & Types

cliniminds
TM
An ISO 9001:2000
 Data Management Plan

 Electronic Data Capture
 Tracking CRF Data
 Managing Lab Data
 Collecting Adverse Event Data
 Creating Reports and Transferring Data
 Enterprise Clinical Data Management Tools
SAS
 Introduction to SAS System
 Manipulating Data
 Data Step
 Setting and Merging SAS Data sets
 Creating a SAS data set form raw data
 Grouping Data Values
 Reading and combining SAS data sets.
 Relating information from multiple sources
 Data translation
 Manipulating and formatting date values
 Programming Techniques
 Do Loops
 Arrays
 Retaining data across observations
 Presenting data
 Writing simple reports for clinical data
 Descriptive statistics and summaries
 Formatting tools
 Charting data
 Plotting data
 Introduction of analysis used in clinical trials
The qualifications are intended to:
 Provide a known standard of professional qualification.

 Facilitate the recruitment of experienced staff.
 Enhance career opportunities for Clinical Data Managers.
Course Objectives
 To increase the understanding of the clinical research process.

 Understanding of Databases & management of clinical data and SAS used in clinical trials.
 Understanding of key enterprise clinical data management tools.

cliniminds
TM
An ISO 9001:2000
Post Graduate Diploma in Regulatory Affairs

CROs and hospitals.
Credit/Debit Cards.
Program Details : This course has especially been designed for the students who would like to develop their
career in the field of regulatory. Upon completion of the program students would understand the
concept of Regulatory Affairs in the field of pharmaceuticals, clinical research, patents &
pharmacoviglance; how the product is marketed on other countries, what are the legal
requirements of regulatory bodies, procedure for the submission of documents etc. After
completion of the program, students would become reasonably well versed in regulations
governing pharmaceutical and clinical research domain. Program would include :
 Introduction to Clinical Research

 Principles of Good Clinical Practices
 Ethical Considerations in Clinical Research
 Indian Regulatory Environment
 Introduction to Regulatory Affairs
 Pharma Regulations Practices & Procedures
 Import and Export of Drugs in India
 Good Manufacturing Practice
 Quality Assurance and Regulation
 Regulations Governing Clinical Trials & New Drugs
 Drug Policy in India
 Future of Regulatory Compliance
 Orphan Drugs

cliniminds
TM
An ISO 9001:2000
 Regulation In Pharmaceutical Devices

 Trips and Pharma Industry
 Biomedical Intellectual Property Management
 Patent Application Processing Flowchart
Course Objectives
 To increase the understanding of the regulatory process in the field of Pharmaceuticals, clinical research, pharmacovigilance
& patents.

cliniminds
TM
An ISO 9001:2000
Post Graduate Diploma in Medical and Scientific Content Writing

Mode : Distance/Online Learning (With Contact Workshop)
CROs and hospitals.
Credit/Debit Cards.
 Introduction to Scientific/ Medical Writing

 Writing Tips / Overcoming Writers Block
 Documents in Clinical Research
 Documents in Medico-marketing
 Publication Writing
 Handling statistics in medical writing
 Effective Internet Literature Search
 Referencing guidelines
 Legal / Copyright Issues in Medical Writing
Course Objectives
 It is ironical that one side there is no dearth of clinical research and advances in medicine, while on the other side, the skills
that are required to share it with the world and express the results in a scientifically approved manner is being ignored; field
of medical writing!
 Although the term ‘medical writing’ is a very broad, it mainly involves writing associated with clinical trials, regulatory
submissions, pharmacovigilance, and marketing or promotional literatures.
 The key objective of this course is to gain an insight into the various aspects of scientific/ medical writing and will help the
writers to make a positive contribution to the medical world, through their documentation.
End result

cliniminds
TM
An ISO 9001:2000
 On completion of this course, students will have an understanding of the requirements, roles and responsibilities of
medical/scientific content writers. Skills in language, scientific communication, and data presentation will be enhanced and
the expertise and knowledge will enable writers to prepare drafts that are clearly written and follow the relevant guidelines.

cliniminds
TM
An ISO 9001:2000
Post Graduate Diploma in Clinical Research for Nurses

Mode : Distance/Online Learning (With Contact Program)
Eligibility : Degree or Diploma in Nursing.
Credit/Debit Cards.
Program Details : This is a comprehensive educational program, designed for the Nurses aspiring to work in the
field of clinical research or allied professions like central labs. The program provides complete
overview and practical environment in the field of clinical research. The program would
candidates to upgrade their knowledge about ICH GCP Guidelines, regulatory issues and other
major aspects of clinical trials management. Program would help Nurses in developing career in
the field of clinical research:

Course Objectives
 To understand the role and opportunities for nurses in clinical research.

 To increase the understanding of the clinical research process.
 Learn the essentials skills, knowledge and competencies of a candidate for the entry level Clinical Research Associate /
Clinical Research Coordinator position and other entry level positions.
 Become familiar with roles/jobs as part of the study team.

cliniminds
TM
An ISO 9001:2000
Post Graduate Diploma in Biostatistics

Biostatistics involves the theory and application of statistical science to analyze public health problems and to further biomedical
research.
This course is intended as an introduction to basic statistics in clinical research.

CROs and hospitals.
Credit/Debit Cards.
Program Details : Biostatistics involves the theory and application of statistical science to analyze public health
problems and to further biomedical research. This course is intended as an introduction to basic
statistics in clinical research:
 Introduction to Research and Statistics/Descriptive Statistics/Probability/Probability

Distributions
 Sampling Distributions/Statistical Inference
 Correlation and Regression
 Choosing Statistical Tests/ T-Test, Chi-Square Test, ANOVA, etc
 Analysis of Categorical Data and Non Parametric Tests
 Introduction to Statistical Softwares
Course Objectives
 To understand the basics of statistics and its application in Clinical Research field.
 To train students in interpretation and presentation of data collected during the conduct of a study.
 To impart examples of utilisation of data in decision making.
 Understanding various techniques of statistical tests in Clinical Research.
 To make students aware of pitfalls in statistical analysis.
 Understanding research oriented statistical concepts.

cliniminds
TM
An ISO 9001:2000
Post Graduate Diploma cGMP – Good Manufacturing Practices

(Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices)

Eligibility : This course is designed for those who work in a Good Manufacturing Practices (GMP)
environment and for those who are responsible for implementing or maintaining GMP
Compliance and Quality Assurance in the manufacture of pharmaceutical products.
Credit/Debit Cards.
 Introduction to GMP
 Basic elements of a Quality Assurance program
 Roles of personnel working in GMP environments
 Facility design for cGMP compliance
 Concept of Clean Room
 Validation & Qualification Principles
 Risk Assessment & Process Control Plans
 Documentation for cGMP compliance
 Audits: Self Inspection, Vendor Audits
 Procurement
 Utility systems for the Pharmaceutical Industry
Course Objectives
On completion of this subject students will be able to:

 State the underlying principles of GMP & Quality, their significance in the industry, and develop practical strategies to apply
those principles in the workplace.
 Integrate GMP elements into a Quality System.
 Identify areas of GMP non-compliance and propose and implement corrective actions.
 Understand the scope of failure investigations in order to conduct and document effective investigations.
 Define the current trends in International GMP compliance.

cliniminds
TM
An ISO 9001:2000
 In addition, the participants are expected to gain an understanding of current requirements and future international trends
within our industry.

cliniminds
TM
An ISO 9001:2000
Certificate Program in Clinical Trials Auditing & Inspection

CROs and hospitals.
Credit/Debit Cards.
Program Details : Audits and Inspections for Clinical Trials” is program designed for those involved in
preparing for and overseeing GCP inspections and those responsible for quality assurance and
auditing. The program has also been designed for the professionals who have just entered in the
field of clinical research, or would like to build career in the domain of Quality Assurance:
The course has been outlined in a the following sequence:

Group 1 An Introduction of Quality
 Importance of quality in Clinical Trials,
 Quality control and quality assurance in clinical research
 Emphasis of QC and QA as per ICH-GCP
 Process mapping in clinical research
 Exercise
Group 2 Audits
 Definition
 Different types of Audits
 Audit tools
 Who are Auditors
 Preparation of an Audit
 Conduct of an Audit
 Audit findings, responding to them.
 Case Exercises
Group 3 Regulatory Inspections (this includes preparation, conduct, responding and consequences of each type of inspection)
 FDA
 EMEA

cliniminds
TM
An ISO 9001:2000
 MHRA
 ANVISA
 DCGI
 Exercises
Group 4 Fraud, Misconduct and Errors
 Definitions of each,
 Reasons
 Types of fraud and Misconduct,
 Consequences, with examples.
Course Objectives
 Upon completion of the program, students would be able to understand the basics concept of quality assurance in clinical
trials; process and implications of Audits & Regulatory inspections and the issue of Frauds and misconduct. The program is
practical in nature and students would be able to apply the knowledge in the work environment as well.

cliniminds
TM
An ISO 9001:2000
ICH GCP Certificate Program in Clinical Research for Medical Practitioners

BECOME A CERTIFIED CLINICAL TRIAL INVESTIGATOR AND BE A PART OF THE BOOMING INDIAN
CLINICAL RESEARCH SUCCESS STORY
Why consider being a clinical trial investigator?
Clinical trials are defined as any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or
pharmacodynamic effects of an investigational product with the object of determining safety and/or efficacy. It is through these trials
that investigational drugs, devices, and diagnostics may show their benefits.
Clinical trials have several layers of protection for human subjects including, Regulatory bodies (viz. USFDA; DCGI, ICMR);
Independent Ethics Committees & Institutional Review Board (IRB), data safety monitoring boards (DSMB) that review the data
while a clinical trial is in progress to ensure that subjects are not exposed to undue risk and careful monitoring and attention from the
investigator and sponsor. Being involved in clinical research can be a positive experience offering an opportunity to learn, become
exposed to new medical therapies and provide additional options or alternative treatments for your patient population.
 Explore New Treatments and/or expense support for Patients
 Publications
 Revenue support
 Opportunity for PI and trainees to learn and expand skills
Gain experience and credentials that could lead to grant funding and investigator initiated ventures.
Mode : Distance/Online Learning (With Contact Workshop)

Eligibility : MD, MS, MBBS, BDS, BHMS.
Credit/Debit Cards.
Program Details : This program consists of modules on topics related to Good Clinical Practice (GCP),
applicable to clinical research. This course is intended to provide the necessary training for
investigators and other senior site personnel, to better understand the regulations regarding clinical
research in human subjects, and a better understanding of roles and responsibilities in planning
and conducting clinical trials. The program also covers the regulatory aspects as well. Key topics

 Ethical Considerations in Clinical Trials

cliniminds
TM
An ISO 9001:2000
 Indian GCP Guidelines, Schedule Y & ICMR Guidelines

 Regulations in Clinical Research
 Sponsor/Investigator Responsibilities
 Investigator Responsibilities
 Clinical Trial Design
 Protocol Design
 CRF Design
 Essential Documents in Clinical Research
 IND Application
 Clinical Study Report
 NDA Submission
 Informed Consent Process & Documentation
 Site Selection & Pre-study Visits
 Site Initiation
 Subjects Recruitment & Retention Plan
 Site Contracts & Budgeting
 Routine Site Monitoring
 CRF Review & Source Data Verification
 Adverse Event Reporting
 Drug Safety Reporting
 Drug Accountability
 Site Close-out
 Standard Operating Procedures for Clinical Research
 Sponsor Compliance & Audits
 Site Audit
Course Objectives
 To increase the understanding of the Clinical Research process.

 To develop skills and knowledge required to be a Certified Investigator
 Learn the essential skills, knowledge, competencies and roles & responsibilities of an investigator & site personnel.

cliniminds
TM
An ISO 9001:2000
Certificate Program in Conducting & Managing Bioequivalence & Bioavailability Studies

CROs and hospitals.
Methodology : Printed Training Modules; Online Learning System.
Credit/Debit Cards.
Program Details : This is a continuing training / educational program designed to provide a practical knowledge
for the clinical research professionals, potential staff for the BA/BE centers or CROs, other
pharmaceutical industry professionals and fresh science graduates & post graduates including
sales and marketing personnel and the students of pharmacy and other life science stream. The
program would cover:

 Drug Discovery & Development
 Sponsor/Investigator Responsibilities
 Sponsor Responsibilities
 Ethics Committees & Institutional Review Board
 Clinical Trial Design
 Protocol Design
 CRF Design
 Informed Consent Process & Documentation
 Current Scenario of Clinical Research
 Introduction to Major Pharma Regulatory Authorities and The Guidelines
 IND & ANDA Investigational New Drug Application
 Introduction to BA/BE and Phase-I Study
 Types of BE Studies
 Designing and Conducting BA/BE Studies
 Conduct & Management of BA/BE Studies

cliniminds
TM
An ISO 9001:2000
Course Objectives
 Distinguish between bioequivalence and bioavailability

 Understanding the management and conduct of bioequivalence and bioavailability studies
 Understand how factors related to the dosage form and patient variables affect drug stability, dissolution capacity, and
absorption properties
 Recognize problems that arise with bioequivalence and generic substitution
 Learn which critical patient and disease factors require special consideration
 Understand the process of approval of generic drugs in USA, Europe and India.

cliniminds
TM
An ISO 9001:2000
Certificate Program in Quality Assurance in Clinical Research

CROs and hospitals.
Credit/Debit Cards.
Program Details : The program has been developed to provide comprehensive training on the process of Quality
assurance in clinical research. The program is targeted towards both, the working professionals
and the students who would like to take QA in Clinical research as career option:
 History of Drug Regulations

 Introduction and role of Quality Assurance in CRO
 QA activities in CRO
 Quality Assurance Plan
 Operational QC
 SOP for QA activities in CRO
 Site Management metrics
 Study site audits
 Internal audits types - in process and retrospective data audits, system and process audits
Data management metrics Statistical analysis metrics
 Corrective and preventive action
 Continual improvement process
 An overview of different regulatory agencies-FDA,EU and DCGI
Course Objectives
 To increase the understanding of Quality assurance process in Clinical research.

 To understand importance of QA in Clinical research.
 Learn the essentials skills, processes, knowledge and competencies to be a QA Professional.

cliniminds
TM
An ISO 9001:2000
Certificate Program in Clinical Trial Regulations & GCP in Europe & U.K.
This course has been designed for clinical research professionals and those working with them involved in carrying out clinical trials.
Primarily, it is for the following disciplines:
 Clinical research operations

 Quality Assurance Auditors
 Regulatory affairs
 Clinical trial supply
 Site Personnel
 CRO personnel
 Medical Writers
 Drug Development department
 All personnel who need to understand the impact of the EU Clinical Trials Directive

CROs and hospitals.
Credit/Debit Cards.
Program Details : This course focuses on understanding the requirements of the EU Clinical Trial Directive,
GCP and GMP directives, marketing authorization process in EU, UK, Germany and France:
Key topics discussed

 Background and History of Clinical Research Legislation in Europe : The current regulatory situation in relation to clinical
trials in the EU.
 Eudralex Vol 10 - Clinical Trials: content, authorization procedure, Inspections, Pharmacovigilance, EC submission and
approval, monitoring etc.
 The Clinical Trials Directive (2001/20/EC) : Content, integration of GCP and GMP, role of Qualifies person, Inspection
procedure.
 The GCP Directive (2005/28/EC) :
 The GMP Directive (2003/94/EC) : GMP requirements for IMP and NIMP, certifications, QP role and responsibilities, GMP
certificate.

cliniminds
TM
An ISO 9001:2000
 The Paediatric Regulations (1901/2006 and 1902/2006): Recent developments and amendments done, pediatric plan, role of
pediatric committee.
 European Guidelines: ICH-GCP, Roles and responsibilities of Sponsor, Investigator, EC. Important tenets of GCP.
 MHRA guidelines on Clinical Trials: Organization, framework, Clinical trial application process, Inspection procedure,
communication flow between EMEA and MHRA
 Authorization procedure in Germany and France: Procedure to apply for obtaining market authorization in Germany and
France
Course Objectives
 Upon completion of this course students will have a thorough knowledge of the EU Clinical Trial Directive requirements.
This will give latest information regarding the interpretation and enforcement of EU regulations and impact of directives on
regulations. Also, it will enlighten students about authorization procedure in EMEA, UK, Germany and France.

cliniminds
TM
An ISO 9001:2000
Certificate Program for Conducting & Managing Clinical Trials for Cancer Patients
CROs and hospitals.
Credit/Debit Cards.

 Indian GCP Guidelines, Schedule Y & ICMR Guidelines
 Drug Discovery & Development.
 Conducting & Managing of Clinical Trials for Cancer Patients - Introduction
 Drug Development “From molecule to medicine”
 Drug Approval for Clinical Trials
 Cancer Clinical Trials: What is this?—An Introduction.
 Components of Cancer Clinical Trials
 Requirements
 Conducting Clinical Trials
 Interpretation of Results
 Drug Approval and Regulatory Affairs
 Understanding Barriers:
 How to Overcome Barriers?
 Benefits
 Education and Development
Course Objectives
 Understand the issues involved in conduct & management of cancer clinical trials.

cliniminds
TM
An ISO 9001:2000

cliniminds
TM
An ISO 9001:2000
Certificate Program for Clinical Trial Investigators & Site Personnel

CROs and hospitals.
Credit/Debit Cards.
Program Details : This program consists of modules on topics related to Good Clinical Practice (GCP),
applicable to clinical research. This course is intended to provide the necessary training for
investigators and other senior site personnel, to better understand the regulations regarding clinical
research in human subjects, and a better understanding of roles and responsibilities in planning
and conducting clinical trials. The program also covers the regulatory aspects as well. Key topics
 Introduction to Clinical Research & Phases of Clinical Trials

 Introduction to ICH GCP / Schedule Y
 Ethical Considerations in Clinical Research
 Investigator Roles & Responsibilities
 "Informed Consent Process & Documentation"
 Safety Reporting
 Study Drug Accountability
 Site Selection Process and Pre-Study Visits
 Routine Site Monitoring Visits
 Site Audits
 Site Close Out
Course Objectives
 To increase the understanding of the Clinical Research process

 Learn the essential skills, knowledge, competencies and roles & responsibilities of an investigator & site personnel.

cliniminds
TM
An ISO 9001:2000
Certificate Program for Monitoring of Clinical Trials

CROs and hospitals.
Credit/Debit Cards.
 Introduction to Clinical Research & Phases of Clinical Trials

 Indian Schedule Y & Other Guidelines
 Sponsor/Vendor Responsibilities
 Essential Documents in Clinical Research
 Protocol Writing
 CRF Design
 Site Selection Process
 Pre-study Site Visits Monitoring
 Site Initiation Monitoring
 Routine Monitoring Visit
 Case Report Form Review and Source Document Verification
 Safety Reporting Monitoring
 Study Drug Accountability Monitoring
 Site Close-out Monitoring
 Informed Consent – Process & Documentation
 Investigational Site Audits

cliniminds
TM
An ISO 9001:2000
Course Objectives

 To provide comprehensive understanding of the monitoring process.

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Join $20 billion Global Clinical Research Industry

Why Career in Clinical Research?

Cliniminds Offers High Quality Professional Training Programs in

Types of Jobs / Positions

Key Features of Cliniminds Programs

Teaching & Training Techniques

Certification & Accreditation

Online Learning System

Indian Clinical Research Industry

Key Cities in India for Clinical Research

India Hub of Global Clinical Research

Key Companies in Clinical Research in India

Cliniminds Clinical Research Programs

2. Integrated Post Graduate Diploma in Clinical Research & Pharmacovigilance

3. Advanced Post Graduate Diploma in Clinical Research

4. Diploma in Clinical Research

5. Post Graduate Diploma in Pharmacovigilance

6. Post Graduate Diploma in Clinical Data Management & SAS

7. Post Graduate Diploma in Regulatory Affairs

8. Post Graduate Diploma in Medical and Scientific Content Writing

9. Post Graduate Diploma in Clinical Research for Nurses

10. Post Graduate Diploma in Biostatistics

11. Post Graduate Diploma in cGMP – Good Manufacturing Practices

12. Post Graduate Diploma in Patents & IPRs

13. Certificate Program in Clinical Trials Auditing & Inspection

16. Certificate Program in Quality Assurance in Clinical Research

20. Certificate Program in Monitoring of Clinical Trials

21. Certificate Program in Clinical Research for Medical Devices

Post Graduate Diploma in Clinical Trials Management

 Clinical Research Introduction & Terminology

Integrated Post Graduate Diploma in Clinical Research & Pharmacovigilance

 Identifying new information about hazards associated with medicines

Mode : Class Room – Weekend

 Clinical Research Introduction

 Clinical Trials Project Planning & Management

 To provide a comprehensive introduction to the clinical research process.

Advanced Post Graduate Diploma in Clinical Research

 Clinical Research Introduction

 To provide a comprehensive introduction to the clinical research process.

Diploma in Clinical Research

 Clinical Research Introduction

 To provide a comprehensive introduction to the clinical research process.

Post Graduate Diploma in Pharmacovigilance

 Introduction to Clinical Research & Phases in Clinical Research

 Candidate should able to understand the.

Post Graduate Diploma in Clinical Data Management & SAS

 Data Management Plan

The qualifications are intended to:

 Provide a known standard of professional qualification.

 To increase the understanding of the clinical research process.

Post Graduate Diploma in Regulatory Affairs

 Introduction to Clinical Research

 Regulation In Pharmaceutical Devices

Post Graduate Diploma in Medical and Scientific Content Writing

 Introduction to Scientific/ Medical Writing

Post Graduate Diploma in Clinical Research for Nurses

 Clinical Research Introduction

 To understand the role and opportunities for nurses in clinical research.

Post Graduate Diploma in Biostatistics

This course is intended as an introduction to basic statistics in clinical research.

Mode : Distance/Online Learning

 Introduction to Research and Statistics/Descriptive Statistics/Probability/Probability

Post Graduate Diploma cGMP – Good Manufacturing Practices

Mode : Distance/Online Learning