The document summarizes an advance program in clinical trial research and data management offered by the Bioinformatics Institute of India. The 6-month weekend program provides theoretical and practical training in clinical trial design, conduct, analysis and regulation. It includes classroom lectures, guest speakers and a clinical site visit. The program aims to prepare students for careers in the growing field of clinical research.

1. 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)

2. Advance Program in Clinical Trial, Research & Data Management- Details Advance Program in Clinical Trial, Research & Data Management Discussions…… Clinical Trial Industry & Career Prospects Bioinformatics Institute of India INDEX

3. BIOINFORMATICS INSTITUTE OF INDIA

4. Bioinformatics Institute of India Bioinformatics Institute of India Classroom Programs Distance Participation Programs Online Programs Project / Trainings Publications Corporate Trainings

5. 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 15 th Dec’08

6. 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. Advance Program in Clinical Trials 6 month Weekend Classes on every Sunday E-learning opportunity Guest Lectures of Industry Veterans Research Study Clinical Site Visits

7. 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

8. CLINICAL TRIAL INDUSTRY & CAREER PROSPECTS

9. 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

10. Clinical Trial Process

11. Leading Companies in Clinical Trial

12. Leading Companies in Clinical Trial

13. Clinical Trial Industry Source: Mckinsey Report 30,000 6000 1500 Site – staff Requirement 300,000 50,000 10,000 Patient Load 20,000 4000 800 Full time staff Requirement 875 300 75 Revenue (Crore INR) 1000 200 50 Value (million USD) 2010 2008 2003

14. 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.

15. 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

16. 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

17. Advance Program in Clinical Trial, Research & Data Management DETAILS

18. 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

19. 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.

20. Program Methodology

21. Program Details Program Duration 6 months Weekend classes On 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)

22. 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

23. 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 – 10 th , 10+2, graduation / Post –graduation 1 Photographs) Personal & Telephonic Interview

24. Dr. Neena Valecha (Scientist F) Mr.G.K.Srivastava M.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 )

25. BII Courseware

26. Logos of the companies our program participants are associated with

27. 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

28. 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.

29. Program Curriculum Module –I Clinical Trials and Clinical Trials Environment Module-IV Contract Research Module-II Statistics for Clinical 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

30. Program Award After completion of the Program the participant will be provided with the following certificate (Sample)

31. Thank You For Further Details & Enquiries Contact: Bioinformatics Institute of India C-56A / 28, Sector – 62 Noida – 2010301, U.P Tel: 0120-4320801/02 Mobile: 9818473366, 9810535368 Email: info@bii.in Visit: www.bii.in