Our Post Graduate Course in Clinical Research with certification is specifically designed to meet the growing needs of trained professionals in the clinical research industry

• Highlights of the Program

  • International Approach- In modern clinical research and biopharmaceutical industry, specialists are expected to be familiar with research and development practices on a global scale. Our programs are designed to cover International and Local Regulations with strong emphasis on the USA, Canada, United Kingdom, European Union, Australia and Israel.
  • Industry-focused curriculum - It is a unique program that is specifically designed to meet growing needs of trained professionals in the clinical research industry.
  • Internships and practical experience opportunities - It is one of the few programs that provide professional development opportunities to students through expert guest lectures and internships to help them gain broader industry perspective and valuable practical experience.

• Summary of course content

  • Module I - Introduction to Clinical Research Process of drug development and pharmacology with an emphasis on general pharmacology, actions of drug, metabolism distribution, pharmacokinetics, pharmacodynamics, Detailed information on different Drug approval process and phases of clinical trial, Importance of Ethical principles in clinical research
  • Module II - Clinical Research Operations Includes Clinical Trial Management and Budgeting, Introduces to the personnel involved in the Clinical trial and their job responsibilities, Various stages of clinical trial, Methods of clinical research processes as related to pharmaceutical and drug manufacturing.
  • Module III - Data management in clinical trials Methodologies applied for the process of Clinical research including the knowledge about production of Statistical reports and graphs. Includes Clinical data management with an emphasis on SAS/Alternative software, how to capture and process the data during and after the trial is closed. Introduction to Six Sigma
  • Module IV - Quality assurance and regulatory affairs Involves all the aspects of Quality assurance required for the smooth conduct of clinical trial which includes Responsibilities of quality functions, Purpose of QA documentation, Aspects of GLP and GMP with respect to pharmaceuticals. Regulatory affairs with respect to Drug Regulatory act. Overview of Regulatory Affairs Industry. GMP in Complete process of Drug manufacturing.

• Teaching Methodology

  The goal of training in this program is to equip students with specific knowledge and skill-sets required to succeed in clinical research industry and with the abilities to apply the classroom training in real-life work environments. To that end, the approach to teaching is non-didactic and practical. The students will learn through:

  • Interactive lectures Group discussions
  • Case studies /assignments
  • Audio- Visual materials (Pre-recorded lectures from US delivered by Industry/University Experts)
  • Expert Guest lectures
  • A clear presentation of training objectives at the beginning of each session.
  • Soft skill development programs - Exploration of personal attitudes
  • Promotion of attitudes such as ‘Openness’ and ‘Introspection’

  While doing courses from C .B. Patel Research Centre, Mumbai, students will receive dual support: notes and Classroom teaching.

• Eligibility

  2nd & 3rd year B.Sc. / M.Sc. in Life Science, Microbiology, Genetics, Biotechnology, Zoology, Chemistry, Nursing, Botany, Biochemistry, B. Pharm., M. Pharm., MBBS, BDS, BAMS, BPT and B.O.T. with minimum 50% marks