Clinical Research Courses

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

Eligibility: Life science/ Medical/ Pharma graduates and post graduates

Duration: 2 – 3 months theoretical (self paced)+ 3 months internship*

Course Curriculum:

• Introduction to Clinical Research
• Evolution of GCP
• Principles of GCP + Practical Application + Case Studies
• Phases of clinical trials and drug development process
• Medical terminologies in clinical research
• Drug & Cosmetic Act 2019 
• Informed Consent, Elements and Documentation
• Essential documents in clinical research
• Source Documentation
• Overview of Trial Design and Protocol Writing 
• AE / SAE Reporting
• Fundamentals of Clinical Data Management
• Fundamental of Pharmacovigilance

* Internship opportunity: Offered to selected students who excel in the exams.

Other benefits:

• Notes 
• Regular doubt clearing sessions
• Periodic revision
• 100% placement assistance

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Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availability of appropriate data.

Eligibility:

• Life Science/Medical/Pharma Graduates
• Candidates with more than six months experience in Clinical Research can directly apply for Advanced Clinical Data Management module of 3 months

Duration: 5 – 6 months (self paced)

Course Curriculum: 

Entire course curriculum of the Clinical Research course + Clinical Data Management course 

Clinical Data Management course curriculum:

• Medical Writing: Trial design
• Protocol Writing Theory
• Medical Writing: Protocol Writing-2 [Practical]
• Medical Writing: CRF design
• Medical Writing: e CRF design + Practical
• CDM Theory: Overview of Clinical Data Management (CDM)
• CDM Theory: Study startup
• CDM Theory: Study Conduct
• CDM Theory: Study Closeout
• CDM Theory: Discrepancy Management+GCDMP+21CFR
• CDM Practical: Data entry in eCRF solution
• CDM Practical: Double Data entry in eCRF solution
• CDM Practical: Query raising
• CDM Practical: Query resolution + Source Data verification

Other benefits: 

• Notes 
• Regular doubt clearing sessions
• Periodic revision
• 100% placement assistance

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Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Eligibility:

• Life Science/Medical/Pharma Graduates
• Candidates with more than six months experience in Clinical Research can directly apply for Advanced Pharmacovigilance module of 3 months

Duration: 5 – 6 months

Course Curriculum:

Entire course curriculum of the Clinical Research course + Pharmacovigilance course 

Pharmacovigilance course curriculum:

• General Overview of Pharmacovigilance
• PV – Basic principles of PV and AE / ADR reporting system 
• Global Pharmacovigilance Regulatory Requirements in Pharmacovigilance 
• Safety Data Management
• Safety Data Reporting
• General Overview of GVP
• Quality in Pharmacovigilance
• Safety Signal Management
• Drug Safety in Clinical Trials 
• Overview of Safety Database and forms used in the actual scenario

Other benefits:

• Notes 
• Regular doubt clearing sessions
• Periodic revision
• 100% placement assistance

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