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M.Sc. - Clinical Research and Experimental Medicine
Programs Offered
Programme Overview
The M.Sc. Clinical Research programme at the Department of Clinical Research and Experimental Medicine (CREM), School of Allied and Healthcare Sciences, Malla Reddy University, is a two-year postgraduate programme designed to prepare graduates for careers in the pharmaceutical, biotechnology, medical device, healthcare, and contract research industries.
The curriculum integrates biomedical sciences with clinical research methodologies, regulatory requirements, pharmacovigilance, biostatistics, data management, ethics, and emerging digital technologies. Students gain theoretical knowledge, practical skills, and research experience required to conduct and manage clinical trials in accordance with international standards.
Programme Duration
Duration: 2 Years (4 Semesters)
Credits: As per NEP/University Regulations
Curriculum Structure
Semester I – Foundations of Clinical Research
Fundamentals of Clinical Research
Human Anatomy & Physiology
Clinical Pharmacology
Medical Therapeutics
Guidelines and Regulations in Clinical Research
Practicals and Seminar
Clinical Training
Semester II – Clinical Trial Operations
Clinical Trial Management
Pharmacovigilance & Regulatory Affairs
Clinical Data Management
Medical Writing
Research Methodology & Biostatistics
Practicals and Seminar
Clinical Training
Semester III – Advanced Clinical Research
Scientific Writing and Intellectual Property Rights
Bioethics and Good Clinical Practice (ICH-GCP)
· Clinical Internship / Hospital & Industry Training
· Research project
Semester IV – Research and Professional Training
Dissertation / Research Project
Clinical Training
A unique feature of the M.Sc. Clinical Research programme at Malla Reddy University is the integrated clinical training offered at the University's own Malla Reddy Clinical Research Unit (CRU). This continuous, hands-on training provides students with early and sustained exposure to the clinical research environment, allowing them to apply classroom concepts to real-world research settings.
Through the CRU, students actively participate in various aspects of clinical research, including clinical trial coordination, informed consent procedures, patient screening and recruitment, data collection, source document verification, pharmacovigilance activities, regulatory documentation, and Good Clinical Practice (ICH-GCP) compliance. The programme also incorporates case discussions, seminars, protocol reviews, and interactions with clinicians and research professionals to strengthen analytical, communication, and professional skills.
Semester-wise Clinical Training
Semester I: Orientation to Clinical Research and exposure to the Clinical Research Unit (CRU); introduction to GCP, clinical documentation, and research ethics.
Semester II: Training in clinical trial operations, informed consent, pharmacovigilance, regulatory documentation, and clinical data management.
Semester III: Advanced clinical training involving patient recruitment, trial coordination, monitoring activities, protocol implementation, and case presentations.
Semester IV: Internship at Various organisations. Dissertation with independent research, data analysis, scientific writing, and viva voce.
