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

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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

(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. A

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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

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 Duration12 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 – 10th, 10+2, graduation / Post –graduation

2 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

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 KhanM.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

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: info@bii.inVisit: www.bii.in