Course Description:
The Certificate Program in Clinical Research is a 6 months course in the branch
of Clinical Research & Healthcare Sciences.
The program enables you to master theory and 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
Learning Outcome :
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To understand the protocol or study design and the concept of Clinical Trials.
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To perform database or procedure testing, data validation, SAE reconciliation and medical coding
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To learn the Processes of Drug Development
- To understand the Ethics & regulatory perspectives on clinical research trials activities .
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To understand how pharmacovigilance , Project Management and Medical Affairs
teams function and coordinate with different stakeholders.
Course Objectives:
The main objective of this course is to develop experts or skilled professionals to
handle large clinical data procedure with correct guidelines, rules and orientation of
clinical research. The course will help participants to acquire a basic understanding
of the concepts and practices of clinical trials in CRO and Pharmaceutical industry.
The course also aims to enable participants to understand issues surrounding the risks
and benefits of drugs used in humans including the cause , manifestations and consequences
of adverse drug effects. The regulatory perspectives of Clinical Trials and Pharmacovigilance,
Project Management are the important parts of the course.
Course Coverage:
The aim of the course is to have thorough insight on project management related to
Introduction to Clinical Trial, Ethics and Regulation, pharmacovigilance or clinical
data management, clinical trial Management and Project Management domain.
Career Opportunities:
- Clinical Research Coordinator
- Clinical Research Associates
- Clinical Research Assistants
- Clinical Data Manager
- Project Manager
- Patient Recruitment Executive and more
Eligibility
Medical Graduates (MBBS, MD, MS, BOS, BAMS, BHMS, BUMS),
Graduate or Post-Graduate Degree in Science, Pharmacology, Pharmacy,
Life Sciences, Medical Laboratory, Nursing, Biochemistry, Microbiology,
Biotechnology, and all professionals working with Pharmaceutical companies
or Clinical Research Organizations.
