clinical research learning program

Learning Program-In Clinical Research
Information Brochure
Leaning Programs @ CRAB
Post Graduate Diploma’s & Certificate
Courses offered in
Clinical Research and
Clinical Data Management
CLINiREACH Research Academy, Bangalore - CRABDivision
of Oriolus Solution Private limited,
N0:4/19, 2ND FLOOR, 20TH MAIN (Next to More Shop)
BTM, 1st stage, Maruthi Nagar main road, Bangalore-560068, Karnataka
Visit us at: www.clinireach.in
Call us at: 080-65464853
E-mail us at: info@crab.com/clinireach@rediffmail.com
Visit us at: www.crab.com
© 2005-2008 CLINiREACH Research Academy, Bangalore 1
Learning Program-In Clinical Research
Welcome
To
CRAB
CLINiREACH Research Academy, Bangalore
For
Learning Programs
© 2005-2008 CLINiREACH Research Academy, Bangalore 2
Learning Program-In Clinical Research
Contents:
About Us
CLINiREACH Research Academy
Vision & Mission
From the MD’s Desk
Objective
Student’s Corner
CLINiREACH Research Academy -Top Quality Education
Programs
Certificate and Diploma Courses
Curriculum and Academic Policies
Education Methodology
Evaluation Methodology
Admission & Fees Policies
Eligibility & Admission Procedure
Enclosures
Fee Schedule, Timelines & Policies
© 2005-2008 CLINiREACH Research Academy, Bangalore 3
Learning Program-In Clinical Research
CLINiREACH Research Academy -An Introduction
The CLINiREACH Research Academy is set up as a not-for profit organization.
To provide quality Services & education and to make them world class professionals.
To provide an in-depth knowledge and training in the applied field of Clinical
Research, Biotechnology, Bioinformatics, Pharmaceutical , Biopharmaceutical,
Agrochemical, Chemical and Biotech industries in a unique amalgamated
environment of research & technology, Training
The Academy is promoting growth and prosperity of Clinical Research and
Bioinformatics sciences in India and Abroad. The CLINiREACH Research Academy
is a premier educational, R&D and development centre. The aim and vision of the
Academy is to provide a platform for individuals, professionals, R&D organizations to
utilize and harness the Indian IT capability in the life science field
CLINiREACH Research Academy - A Pioneer in Clinical
Research Distance Learning Education
The CLINiREACH Research Academy is the pioneer in distance learning education in
Clinical Research in India and Malaysia. Our aim is to propagate clinical research
education to all students and working professionals who don’t have the time or
opportunity to join a full time diploma course. This program aims to upgrade the
technical knowledge of clinical research and enhance the job skills of participants.
© 2005-2008 CLINiREACH Research Academy, Bangalore 4
Learning Program-In Clinical Research
Vision
To be the global center of excellence in the area of Clinical Research,
Bioinformatics and Biotechnology in the nascent Life Sciences Industry
for the Social well being
Mission
To empower the student community with knowledge of Clinical
Research and to provide the platform and opportunity to the young
minds to enter the world of Clinical Research
© 2005-2008 CLINiREACH Research Academy, Bangalore 5
Learning Program-In Clinical Research
From the Managing Director’s Desk
The Clinical Research industry world over is growing at an unparalleled rate. It has
opened up new vistas of employment for a large number of trained professionals. The
clinical trials market worldwide is worth over USD 52 billion and the industry has
employed an estimated 2,10,000 people in the U.S. and over 70,000 in the U.K., and
they form one third of the total Research & Development staff. There are more than
2,50,000 positions vacant globally and salaries vary in the region of approximately
USD 40,000 p.a. for a Clinical Research Coordinator to almost USD 1,00,000 p.a. for
a Business Development Manager. These large numbers speak volumes about the
lucrative Clinical Research career and its vast employment opportunities. Salary
levels for starters are as high as those of Harvard/other Ivy League institutions.
India is recognized as a quality player and preferred partner in global clinical trails.
According to Mc Kinsey Report the global clinical trial outsourcing in India in the
pharmaceutical industry is estimated to reach around Rs. 5000 cores by the year
2010. and there will be a requirement of 50000 Clinical Research professionals.
Clinical Research is definitely the next big career and now is the time to take the first
step.
CLINiREACH Research Academy, is the pioneer in Distance Education in Clinical
Research in India and Malaysia. The curriculum is designed in such a way so that it
covers all aspects of Clinical Research to all technical details of Clinical research,
Data Management , Biostatistics and SAS. The course has two contact sessions to
give hands on practical exposure to the participants.
Welcome to the exciting ,challenging and rewarding career in Clinical Research.
Dr.Vijayakumar D.R
Oriolus Solution Private limited,
-Managing Director-
*************************
CLINiREACH Research Academy, CRAB
Centre for learning
Division of Oriolus Solution Private limited,
Bangalore
© 2005-2008 CLINiREACH Research Academy, Bangalore 6
Learning Program-In Clinical Research
OBJECTIVE
The objective of Professional Diploma in Clinical Research is to provide Individuals
/Students/Professionals from Pharmacy, Medical, Nursing, Life Sciences, Research & Development,
Clinical Research, Allied areas and Academic fields, a basic to advanced level understanding of
various clinical trial processes. The ultimate objective is to train & develop clinical research
professionals by imparting quality education to them.
Clinical Research & Its Potential
India became a member of WTO/GATT/TRIPS in 1995 and implemented the product patent regime in
2005. As part of WTO/GATT/TRIPS, Pharmaceutical Industry has the right to patent products as well
as processes throughout the world including India. This has led to a significant growth in
pharmaceutical industry and increased stakes of multi-national companies in Indian operations.
In light of these changes, Clinical Research has emerged as a leading knowledge based industry of
the new millennium. Clinical research is carried out on healthy volunteers and patients with diseases to
ensure that the drug, which is to be marketed, is safe & effective. It takes approximately 12 years and
US $900 million to introduce a new drug to the market.
Being a signatory of GATT/TRIPS, India is being looked upon as a favorable destination for conducting
global clinical trials. India offers unique advantages that include:
. Lower drug development cost
. Abundance of patients with genetic diversity
. Wide spectrum of disease
. Trained medical professionals
. Skilled manpower and IT enabled infrastructure at a lower cost
. Proficiency in English language
An estimate of total market of clinical trial conduction either directly or through contract research
organization in India by 2010 is projected at US $ 1.5 billion by major Pharmaceutical companies. This
in turn offers huge employment opportunities for the Medicine/pharmacy/life sciences graduate
and post-graduate students. However, clinical research is highly specialized and regulated
profession therefore it requires specific skill sets to carry out various operations, as per global norms.
We at CLINiREACH Research Academy. are committed towards developing India and Malaysia as
a hub for global clinical research by catering to the ever-growing training and compliance needs of the
profession, through specialized training courses and workshops.
STUDENT’S CORNER
What our students say about CLINiREACH.
"I am thankful to CLINiREACH for giving me an opportunity to work with
them in the pioneering field of Clinical Research. The Clinical research
intensive projects undertaken by them will help in future in discovering
the New Drugs for life threatening diseases” Dr. Sayad Ali,
© 2005-2008 CLINiREACH Research Academy, Bangalore 7
Learning Program-In Clinical Research
Job Prospects
Following positions are available to pursue a career in clinical research:
Positions
Site Coordinator
Clinical Research Associate
Regulatory Affair Associate
Business Development Associate
Project Manager
Manager-Clinical Research
Auditors
Medical Advisor
Data Manager
SAS Programmer
Minimum Entry Criteria
Fresher
Fresher or 1-2 year experience
Fresher
Fresher
>3 years experience
>4 years experience
>5 years experience
>5 years clinical experience
1-2 years experience
Fresher
Today’s Students/Professionals from Pharmacy, Medical, Nursing, Life
Sciences, graduates requires a deep foundation in not only life science subjects
but also in industry oriented subjects like clinical research
The CLINiREACH Academy program gears students to become successful CRA and
CDM in any type of CRO. Building on skills and insights gained during the Academy
program, our graduates make significant contribution to the rapidly growing Clinical
Research industry. Our student community consists of fresh life science graduates
aspiring to start a career in Clinical Research, doctors, pharmacists, veterinary
doctors, dentists and other working professionals aspiring for career advancement or
seeking new employment opportunities.
© 2005-2008 CLINiREACH Research Academy, Bangalore 8
Learning Program-In Clinical Research
Our integrated learning methodology goes beyond facts and theories; it is a
Process that teaches individuals the insight of the Clinical Research industry.
An Overview of the program
© 2005-2008 CLINiREACH Research Academy, Bangalore 9
Learning Program-In Clinical Research
Curriculum & Academic Policies
Module 1: Introduction to Clinical research - I
1) Drug Development Process
2) Definitions and Terminology in Clinical Research
3) Clinical Trial Process:
a) Definitions and terminologies in clinical research
b) Brief description of clinical trial phases
Planning and conduct of Clinical Trials
(Including objectives, goals and strategies)
Preclinical trial
Phase – I trials
First human dose
Dose ranging studies (SAD, MAD)
Maximum tolerated dose determination
Phase – II dose determination
Phase – III studies
National, multinational studies
Multicentric studies, advantages & challenges
Phase- IV studies
Pharmacovigilance
Module 2: Introduction to Clinical Research II
GCP glossary-Indian GCP, ICH-GCP guidelines therapeutic and non
therapeutic trials
Schedule Y
Drug Regulatory Affairs(Clinical Research)
GxP and Quality Auditing Practices
© 2005-2008 CLINiREACH Research Academy, Bangalore 10
Learning Program-In Clinical Research
Module 3: Clinical Trial Design
1) Clinical trial Designs
Elements of clinical trial designs
Choice of comparator
Clinical measurement/endpoints
Bias
Basic statistical concepts in clinical trials
Randomization
Types
Procedures
Randomization codes
Randomized controlled trial
Quality of randomized trials
Blinding
Types
Techniques
Significance
Controlled clinical trials
Basic concepts
Types of controls
Therapeutic and non therapeutic trials
© 2005-2008 CLINiREACH Research Academy, Bangalore 11
Learning Program-In Clinical Research
Module 4: Clinical Data Management
a) Data Capture
b) Data Collection Tool Design
c) Forms Management
d) Receipt and Review of Data
e) SOPs
f) Data Entry
g) Data Validation & Data Cleaning
h) Query/Discrepancy Management
i) Coding
j) Data Transfer – ECG and Bioimaging
k) Lab Data
l) Safety Data Management
m) Database Closure
n) QC/QA
Module 5: Oracle Clinical
a)
i) System Overview, Basic Study Set Up
ii) Global Library Management
b)
i) Simple CRF Modelling
ii) CRF Modelling for PDF
c)
i) Data Entry
ii) Discrepancies, Data Clarification
d)
i) Validation and Derivations
ii) Batch Data Loading and Laboratory Overview
e)
i) Data Extract and Access from SAS
ii) Data Loading and Security, Copy Groups
© 2005-2008 CLINiREACH Research Academy, Bangalore 12
Learning Program-In Clinical Research
Module 6: SAS Programming
1) SAS Language
2) SAS Procedures for Data Analysis
3) Looking at Data :Relationships
4) Producing Data
5) Probability: Study of Randomness
6) From Probability to Inference
7) Introduction to Inference
8) Inference for Distribution
9) Inference for Proportions
10) Inference for two way tables
11) Inference for Regression
12) Multiple Regression
13) One way Analysis of Variance
14) Two way Analysis of Variance
15) Nonparametric tests
16) Logistic Regression
Academic Resources
The Academic Development and Research Department plays a key role in designing
and constantly updating the curriculum after careful evaluation and ensures that the
curriculum meets the latest industry trends.
Faculty
CLINiREACH Academy has over 100 consulting faculty members who help
Academics development and Research Department in developing curriculum and
providing academic support to students. Faculty members attend workshops and
corporate training programs to seek innovative teaching methodology and implements
efficient learning systems for the benefit of students.
© 2005-2008 CLINiREACH Research Academy, Bangalore 13
Learning Program-In Clinical Research
Education Methodology
Study Material
All students are provided with comprehensive study material books .Renowned
authors specially design the study material for each subject of the curriculum with the
distance learning methodology in mind. The study material contains self evaluation
questions at the end of each unit.
Contact Classes
CLINiREACH Academy distance learning program has special contact classes on
Statistical Analysis of Clinical data and Data Management system .The contact
session are kept so that students gain hands on experience on all software’s related
to the field of clinical data management.
Evaluation Methodology
At the end of the course there is an examination. All students should mandatorily
clear the examination in order to get their course certificate.
Admission & Fees Policies
Eligibility
Graduates in any field of life sciences including Medicine, Pharmacy, Vetenary,
Dental & Engineering.
© 2005-2008 CLINiREACH Research Academy, Bangalore 14
Learning Program-In Clinical Research
Admission Procedure
Send a DD of Rs. 150/- in favor of “Oriolus Solution (P) Ltd., Bangalore “for the
Application form. Admission will be confirmed after depositing the 1st installment of the
fees along with the completed admission form.
Enclosures with application
1) Copy of Degree Certificate /Provisional Certificate
2) Two copies of recent passport size color photographs
3) Non Refundable 1st installment fees to be submitted along with the application form
by Demand Draft in favor of “Oriolus Solution (P) Ltd payable at Bangalore
Fees Schedule, Timelines & Policies
VISIT: www.crab.com / www.clinireach.in
© 2005-2008 CLINiREACH Research Academy, Bangalore
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COURSES
Course
Code Course Duration & Fees
Duration: 12 months
Regular
Enrolment: Offered throughout the year
Fees: 125,000.00
Duration: 9 months
/ Regular
Enrolment: Offered throughout the year
Fees: 1,00,000.00
Duration: 6 months
Regular
Enrolment: Offered throughout the year
Fees: 50,000.00
Duration: 3 months
/ Regular
Enrolment: Offered throughout the year
Fees: 25,000.00
Duration: 3 months
Regular
Enrolment: Offered throughout the year
Fees: 25,000.00
Duration: 3 months
/ Regular
Enrolment: Offered throughout the year
Fees: 25,000.00
Duration: 3 months
Regular
Enrolment: Offered throughout the year
Fees: 25,000.00
Duration: 3 months
Regular
Enrolment: Offered throughout the year
Fees: 25,000.00
Duration: 6 months
Regular
Enrolment: Offered throughout the year
Fees: 50,000.00
Duration: 3 months
Regular
Enrolment: Offered throughout the year
Fees: 15,000.00
Programme / Course Name
PROFESSIONAL DIPLOMA IN
CLINICAL RESEARCH AND CLINICAL DATA
MANAGEMENT
CRAB001
CRAB002 POST GRADUATE DIPLOMA IN CLINICAL
RESEARCH, DATABASE MANAGEMENT& SAS®
CRAB003 POST GRADUATE DIPLOMA IN CLINICAL
RESEARCH & REGULATORY AFFAIRS
CRAB004 CERTIFICATE PROGRAM IN CLINICAL
OPERATIONS
CRAB005 CERTIFICATE PROGRAM IN AUDITING &
QUALITY ASSURANCE
CRAB006 CERTIFICATE PROGRAM IN PROJECT
MANAGEMENT
CRAB007
CERTIFICATE PROGRAM IN
PHARMACOVIGILANCE
CRAB008 CERTIFICATE PROGRAM IN MEDICAL WRITING
CRAB009 BIOSTATISTICS & SAS® ADVANCED
ANALYTICS
CRAB010 Advanced SAS® Programming With PROC SQL
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© 2005-2008 CLINiREACH Research Academy, Bangalore