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MALLA REDDY VISHWAVIDYAPEETH

(Deemed to be University)

Hyderabad

Recognised under section 3 of The UGC Act, 1956, vide Notification No.9-4/2024-U.3(A) by
Department of Higher Education, Ministry of Education, Government of India.

M.Sc. Clinical Research

This Course Structure is Curated as per the NEP-2020 Guidelines

Course Overview

The M.Sc. Clinical Research program at Malla Reddy Vishwavidyapeeth, Hyderabad, is designed to provide in-depth knowledge and practical training in the methodology, design, and management of clinical trials and research in the healthcare sector. This postgraduate program focuses on equipping students with the necessary skills to contribute to the development of new medical treatments, therapies, and technologies through rigorous clinical research.

This program focuses on equipping students with the theoretical knowledge and hands-on skills from 1st semester itself. The curriculum covers a wide range of topics, including clinical trial design, biostatistics, ethical issues in clinical research, regulatory requirements, pharmacovigilance, data management, and patient safety. Students gain hands-on experience in conducting clinical trials, analyzing data, and interpreting clinical research results, preparing them to contribute effectively to the clinical research and pharmaceutical industries.

Graduates of this program emerge as ‘Skilled Clinical Research Professionals’, enabling them to pursue further higher studies & do research in Clinical Research along with plenty of job opportunities globally in hospitals, research institutions, pharmaceutical companies, CROs (Contract Research Organizations), regulatory agencies, and academic institutions, contributing significantly to advancements in healthcare research and clinical trials.

Course Details

Description: 2 Years Degree Program

No. of Credits: 80 minimum and as specified

A Bachelor’s degree in a relevant field such as Life Sciences, Pharmacy, Medicine, Nursing, or equivalent with at least 50% aggregate marks from a recognized university.

The M.Sc. Clinical Research program spans 4 semesters, combining theoretical coursework with hands-on practical training in clinical research.

Semester

Subjects

Semester 1

Introduction to Clinical Research, Research Methodology, Epidemiology, Bioethics in Clinical Research, Good Clinical Practice (GCP), Clinical Trial Design and Protocol Development

Semester 2

Biostatistics and Data Analysis, Regulatory Affairs in Clinical Research, Clinical Data Management, Pharmacovigilance and Adverse Event Reporting, Patient Recruitment and Retention in Clinical Trials

Semester 3

Advanced Clinical Trial Management, Clinical Research Project Management, Medical Writing and Documentation, Advanced Pharmacology and Therapeutics, Health Economics and Outcomes Research

Semester 4

Internship/Practical Training in Clinical Research, Dissertation/Project Work, Advanced Topics in Clinical Research (Optional Specializations)

  • Clinical Trial Design: Expertise in designing, planning, and conducting clinical trials.
  • Regulatory Knowledge: Understanding of regulatory frameworks like ICH-GCP, FDA guidelines, and other global regulations.
  • Biostatistics: Proficiency in data analysis, statistical methods, and interpreting clinical data.
  • Patient Safety and Ethics: Training in ethical issues, patient safety, and informed consent in clinical trials.
  • Clinical Data Management: Skills in handling, analyzing, and managing clinical trial data.
  • Medical Writing: Expertise in preparing clinical trial reports, research papers, and regulatory documents.
  • Pharmacovigilance: Knowledge in monitoring, assessing, and reporting adverse events and drug safety.
  • Certification in Clinical Research: Professional certification that enhances practical knowledge in clinical research methodologies and regulations.
  • Data Management and Analysis: Training in advanced tools and software for clinical data analysis (e.g., SAS, R).
  • Clinical Research Project Management: Specialized programs to improve project management skills for clinical trials.
  • Medical Writing Certification: Focused programs on medical writing and regulatory submissions.
  • Pharmacovigilance Training: Programs on adverse event reporting, drug safety, and regulatory compliance.
  • Ph.D. in Clinical Research
  • Postgraduate Diploma in Regulatory Affairs
  • Advanced Certificate in Medical Statistics
  • M.B.A. in Healthcare Management
  • Postgraduate Courses in Pharmacology or Bioinformatics

Duration

Roles and Responsibilities

Salary Range

0-3 years

Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Research Assistant

₹4,00,000 – ₹6,00,000 per annum

3-5 years

Senior Clinical Research Associate, Project Manager, Data Analyst, Regulatory Affairs Specialist

₹6,00,000 – ₹9,00,000 per annum

5-10 years

Clinical Research Manager, Clinical Trials Manager, Director of Clinical Operations

₹9,00,000 – ₹14,00,000 per annum

10+ years

Clinical Research Director, Medical Affairs Manager, Senior Research Scientist

₹14,00,000 – ₹20,00,000+ per annum

Fee Structure Per Academic Year

Tuition FeeMiscellaneous FeeScholarship     
200000 ₹10000 ₹Above 90% –  40000 ₹Between 80-90%20000 ₹Between 70-80%10000 ₹