Advance Program in Clinical Trial, Research and Data Management
Offered by: Bioinformatics Institute of India Program Venue: C-56A/28, Sector – 62, Noida - 201301
(6 months Weekend Classroom Program)
Advance Program in Clinical Trial, Research & Data Management- Details
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Clinical Trial Industry & Career Prospects Clinical Trial Industry & Career Prospects
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Weekend Classroom Program
Bioinformatics Institute of India
Advance Program in Clinical Trial,
Research & Data Management
(6 months Weekend Classroom Program)
The classes would commence from 15th Dec’08
Program Highlights
The course would provide students with a theoretical and practical understanding of the issues involved in the design,
conduct, analysis and interpretation of clinical trials. A
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6 month Weekend Classes on every Sunday
E-learning opportunity
Guest Lectures of Industry Veterans
Research Study
Clinical Site Visits
Ongoing batch details
• The ongoing batch is pursued by Doctors, medical professionals, B.Pharma, M.Pharma , Science graduates and post-graduates
• Classes are taken up by many experienced faculty from industry and academia
• Students are also trained to work on “Open Clinical Software” which is used in industry for Clinical Data management
CLINICAL TRIAL INDUSTRY & CAREER PROSPECTS
Clinical Trial
“Clnical Trials evaluate drug, treatment, surgical procedure and medical devices”
Aims are to ensure:
• Safety• Less side effects and• Better treatment leading to improved health care
Clinical Trial Process
Leading Companies in Clinical Trial
Leading Companies in Clinical Trial
Clinical Trial Industry
2003 2008 2010
Value (million USD) 50 200 1000
Revenue (Crore INR) 75 300 875
Full time staff Requirement 800 4000 20,000
Site – staff Requirement 1500 6000 30,000
Patient Load 10,000 50,000 300,000
Source: Mckinsey Report
Career Opportunities
“More than 50,000 professionals will be required in the field of Clinical research in India alone.”
Source : Mckinsey Report
Thus science, pharmacy and medicine graduates can look forward to exciting and rewarding career opportunities in clinical research.
Careers in Clinical Research
Clinical Research Associate
Clinical Research investigator
Study Coordinator
Data manager
Biostatistician
Regulatory Affairs Manager
Clinical Trials Auditor
Clinical Project Manager
Clinical Research Manager
Business development Manger
Drug Safety Associate
Medical Writer
Clinical Trial Quotations
“India is an emerging market with growing number of entrepreneurs foraying into research and healthcare. Indian government is creating an effective regulatory framework. Protection of patents and IPR is now improving. India has a better place than countries like China in the clinical trials field”, Dr Charles Pierce, president Global Clinical Partners, Inc. USA, said Source: Pharmabiz
“Indian contract research Organisations will have good chance to shine, Indian CROs are competitive compared to western companies. There are several advantages to global companies to outsource research service from us”Dr. Goutam Das ,CEO, Syngene International Pvt.Ltd.Source: Chronicle Pharmabiz
Advance Program in Clinical Trial, Research & Data Management
DETAILS
Program Objectives
To provide students with a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials.
Theoretical and practical understanding of clinical trial process
Skills to scrutinize and analyze information
essential features and stages in the conduct of a clinical trial,
Understanding the ethical issues involved
Understanding of uses and applications of intervention studies
Learning Outcomes
Better Understanding of Good Clinical Practice & Standard operating procedures
Can participate in design, conduct & management of Global Clinical trials
Can contribute more effectively in Drug Development
Can be employed for the conduction of Clinical Trials
Handle regulatory affairs as per the changes in the statutory laws.
Program Methodology
Program Details
Program Duration 6 months Weekend classesOn every Sunday at
BII Noida
Program Fees INR 35,000/-Payable at once on the
time of joining
Ist Installment INR 12,000 (on joining time)IInd Installment INR 12,000 ( after 2 months)IIIrd Installment INR 12,000 (after 4 months)
Program Details
Program Eligibility
Graduation / Post Graduation
Medical professionals, Allopathic, Homeo and
Ayurvedic Doctors
Working professionals in the field of MLT,
Medical writing, Medical Transcription
Admission Procedure
Submission of Application Form along with the demand draft of Rs. 300 /- in favor of
Bioinformatics Institute of India, payable at Delhi / Noida.
Enclosures(Marksheet – 10th, 10+2, graduation / Post –graduation
1 Photographs)
Personal & Telephonic Interview
Dr. Neena Valecha (Scientist F)
Mr.G.K.SrivastavaM.Sc. (Molecular Biology and Biotechnology)
PG DIP. in Clinical Research and Clinical Data Management
Dr. Kumud Sarin (Ph.D, Delhi University)
Dr.Anirban Das(M.Tech IIT,Delhi)
( Ph.D, Jamia Milia Islamia University )
Miss Charu Agarwal (MBA, Amity University)
Many more expert faculty from industry
Program Faculty / Team
Mr.Jitendra Chaudhary(MBA, Symbiosis Pune)
Mr. Asif Khan(M.Sc Statistics & Actuarial Sciences)
BII Courseware
Logos of the companies our program participants are associated with
Facilities at BII
•Well Equipped Classrooms •Well Stocked Library •Modern Computer Lab •Specialized course material for Clinical Trials •LCD, OHP and Multimedia Projectors •Moodle E-learning Platform •Clinical Trial Corporate Training Kits •Clinical Trial Software Open ClinicaTM •University Management System ERP AADYA-EDUTM
Placement Support
Bioinformatics Institute of India will provide assistance to all the Program participants for the Placement via its Placement cell & Blog.
BII is already in touch with various CRO’s, Pharma, Biotech Companies and Placement Consultancies for the placement of its students.
Program Curriculum
Module –I Clinical Trials and Clinical Trials Environment
Module-IV Contract Research
Module-II Statistics forClinical Trials
Module-V Regulatory Affairs, GCP, Pharmacovigilance and Ethics
Module-III Clinical Data Management
Module-VI Practical Medical Writing and Documentation
Module-VII Research Study
Program Award
After completion of the Program the participant will be provided with the following certificate (Sample)
Thank You
For Further Details & Enquiries Contact:Bioinformatics Institute of India
C-56A / 28, Sector – 62Noida – 2010301, U.P
Tel: 0120-4320801/02 Mobile: 9818473366, 9810535368Email: [email protected]: www.bii.in