Career Prospects

  • Clinical research taking a new dimension in India after the active involvement of regulatory authorities in recommending effective mechanisms.
  • Regulatory guidelines in India are now gaining acceptance & visibility after sustained efforts from the industry leaders, thus initiating a stronger emphasis on Quality mechanisms in the pharmaceutical industry.
  • The revised Schedule-Y has tremendous impact on design and management of clinical trials in India.

Employment Areas:

The graduated students are placed in various domains of clinical research fields like

  • Clinical Research Associate
  • Clinical Trails Auditor
  • Clinical Research Investigator
  • Clinical Project Manager
  • Data Manager
  • Business Development Manager
  • Bio statistician
  • Drug Safety Associate
  • Regulatory Affairs Manager
  • Medical Writer

About the Course:

Master’s in Clinical Research course aims to provide students with a theoretical and practical understanding of the issues involved in the “Study design, conduct, monitor, document, audit, analysis and interpretation” of clinical trials of health interventions. It will be suitable for students working in high, middle and low income countries.

The various clinical research study modules of Diploma, Adv Diploma and PG Diploma courses taught in Single platform. M.Sc students may choose from a number of advanced modules which will have an opportunity to expand and deepen their conceptual and practical skills.

The main disciplinary perspectives will come from

  • Informed Consent Process
  • Ethics
  • Clinical Studies
  • Clinical Data Management
  • Data Analysis
  • Pharmacovigilance
  • Regulatory affairs
  • Epidemiology.

Students will be trained to develop skills to scrutinize information, to critically analyze and carry out research and to communicate effectively.

Accreditation & Affiliation:

Duration:

2 years (4 Semesters)

Highlights:

  • The study program is like Enter one course avail multi-domain Job opportunity

Eligibility:

  • A recognized bachelor’s degree in any Health Science subject with minimum of 50% marks or Life Sciences graduates with Chemistry/Biochemistry/Organic Chemistry as one of the main subject during their graduation.

Employability:

  • The Clinical Research in India has been facing severe shortage of industry-ready post-graduates for a long time. In an effort to bring about the needs of the industry, Padmashree has started a very unique course where the students will be trained extensively in the field of clinical research.
  • The students will be an extensively trained Health care industry ready personals and the second segment comprises of industry internship where the students get a wonderful opportunity to undergo training in various domains of clinical research program and to get hands on practical experience in various departments.

Syllabus

  • Principles and Practice of Clinical Research
  • Fundamentals of Clinical Operations
  • Basics of Pharmacy, Drug discovery and drug development
  • Laboratory Animals Handling with Special reference to Rats and Mice
  • Fundamentals of Instrumentation Theory, Methods and Analysis
  • Bio statistics in Clinical Research – I
  • Human Physiology I
  • Practical I & II
  • Regulatory affairs and pharmacovigilance
  • Pharmacoeconomics, Health economics and quality of life assessment
  • Bio statistics in Clinical Research – II
  • Human Physiology II
  • Advanced Clinical Research
  • Molecular Biology and Pharmaceutical biotechnology
  • Basics of Human Genetics
  • Practical I & II
  • Bioinformatics for life science research
  • Biostatistics in Clinical Research III
  • Clinical Data Management
  • Clinical Data analysis
  • Good Laboratory practice
  • Medical writing Reviewing and Research affiliations
  • Drug Development for orphan’s diseases and Drug legislation
  • Practical I & II
  • After successful completion of two semesters the student will have to choose one optional subject along with the other two compulsory subjects

Optional Subject

  • Pharmaceutical Biotechnology
  • Pharmacogenomics

Compulsory Subject

  • Statistical Operations & Advanced Analysis
  • Regulatory affairs and Pharmacovigilance

Student has to visit the Clinical Trial operational site as per the schedule drawn each year and undertake as an observer of Clinical operations. Each student will maintain a detailed record of the visits and submit a Report on the same.

Minimum:

  • Two report

Academic Update Activity Series:

The student will deliver a comprehensive Seminar and Journal club on current/recent developments in topic of his/her choice in the field of Clinical Research. The topic of Seminar must be different from the topics covered in any of the other courses.

Minimum:

  • 2 Journal Club and 3 Seminar presentation.