Advance Program in Clinical Trial, Research and Data Management Offered by: Bioinformatics Institute of India Program Venue: C-56A/28, Sector – 62, Noida - 201301 (12 months Weekend Classroom Program)

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

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Weekend Classroom Program Bioinformatics Institute of India Advance Program in Clinical Trial, Research & Data Management (Weekend Classroom Program)

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 Weekend Classes E-learning opportunity Guest Lectures of Industry Veterans Research Study Clinical Site Visits

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

“ 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 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

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 12 months (9 months weekend classes + 3 months Research Project) 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 – 10 th , 10+2, graduation / Post –graduation 2 Photographs) Personal & Telephonic Interview

Dr. Neena Valecha (Scientist F) Mr.G.K.Srivastava M.Sc. (Molecular Biology and Biotechnology) PG DIP. in Clinical Research and Clinical Data Management Miss Shikha Kaushik (B.Pharma, UPTU) Dr. Kumud Sarin (Ph.D, Delhi University) Dr.Anirban Das (M.Tech IIT,Delhi) ( Ph.D, Jamia Milia Islamia University ) Mr.Asif Khan M.Sc Acturial Science, M.Sc Statistics SAS Programmer Many more expert faculty from industry Program Faculty / Team Mr.Jitendra Chaudhary ( MBA, Symbiosis Pune) Miss Charu Agarwal ( MBA, Biotechnology, Amity University)

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

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 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

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 – 62 Noida – 2010301, U.P Tel: 0120-4320801/02 Mobile: 9818473366, 9810535368 Email: info@bii.in Visit: www.bii.in