Electronically-assisted Certificate program

Clinical Research

Clinical Research refers to a study conducted to evaluate a potential treatment and its effects on human beings. Clinical trials help us find out if a promising new treatment is safe and effective.

According to Frost & Sullivan’s industry report, the global CRO market is pegged at around US$20 billion with India’s share being about US$485 million and is is expected to cross the US$1 billion mark by 2015.

Program Summary

Certificate in Clinical Research for Investigators (CCRI) is designed to provide candidates with an opportunity to acquire and develop the expertise necessary to take up roles of an Investigator/ Co-investigator or Clinical Research Associate

The Program enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines and ethical considerations.

Clinical Research Investigator/ Co-Investigator

Investigators are the senior most people at a Clinical Trial site. As an Investigator/ Co-investigator, you not only supplement your income but also add to your knowledge and help discover new medicines

Course Fee

Rs. 30,000/- including study material, Examination etc.

Certification

At the end of the program, successful candidates will receive Certificate in Clinical Research from ICRI

Programme Delivery

The programme utilises Net-based delivery with Online Lectures, assignments. Additionally, classroom interaction sessions are conducted once a month on a Sunday for 2 hours ith Case Study discussions.

Eligibility

M.D. / MBBS / BDS. Candidates need to have access to the internet, printing capabilities and an email address.

Starting Salary

As an Investigator, you have the potential to earn Rs. 10 Lacs to 80 Lacs and as a Co-Investigator; you can earn Rs. 4 Lacs depending upon previous qualification, experience and performance.

Career Center

A database will be created of all the candidates which will be made available to all potential recruiters such as CROs/Pharma companies etc.

PROGRAM OUTLINE

• Introduction To Clinical Research.
• Basic Pharmacology & Pharmacy in CR
• New Drug Development
• Guidelines For Clinical Trials (ICH - GCP)
• Ethics in Clinical Research
• Regulations in Clinical Research
• Biostats & Clinical Trial Designs
• Clinical Trial Documents
• Quality in Clinical Trials
• Clinical Trial Management -Project Management
• Drug Safety & Pharmacovigilance
• Clinical Data Management

Certification in Clinical Research for Investerigators (CCRi)

3 months (60 hours)
Session begins Jan’2012

PROGRAM OBJECTIVES

• Learn the process of drug development
• Gain an understanding of the clinical trials process though a operations-focus approach
• Acquire overview of Pharmacology & Biostatistics
• Gain a global perspective on clinical trials management to better respond to the growing industry.
• Learn how to respond to ethical issues inherent in clinical trials
• Gain practical knowledge through real-world case studies discussions
• Learn about Quality control/ Auditing of Clinical Trials
• Appreciate the process of pharmacovigilance and Safety reporting

TO PREPARE FOR JOBS AS

• Clinical Research Coordinator
• Clinical Research Associates
• Clinical Research Assistants
• Patient Recruitment Executive & more.

Instructional

• Multimedia Presentations
• Online sessions
• Classroom interactions
• Group Discussions

Assessment

• Quick Quizzes
• 4 Assignments
• Case study / Discussions
• 2 Written test
• Viva voce