Our Clinical Research Courses
Course 1
2 Month Course
18,000/-
Advanced Interview-Oriented Skill Development Certification Course In CR, CDM, PV, MW & RA
Course 2
3 Month Course
₹21,000/-
Advanced Interview-Oriented Skill Development Certification Course In CR, CDM, PV, MW & RA
Course 3
3 Month Course
₹24,000/-
Advanced Diploma Certification Course In CR, CDM, PV, MW & RA.
Course 4
6 Month Course
₹51,000/-
Advanced Integrated PG Diploma Certification Course In CR, CDM, PV, MW & RA
Health Economics and Outcomes Research (HEOR) Course
Fees: 81,000/-
Live Project-Based Advanced Diploma Certification Course in
Health Economics and Outcomes Research (HEOR).
Modules of the course:
• Real-World Evidence (RWE)
• Systematic Literature Reviews (SLRs)
• Network Meta-Analysis (NMA)
• Economic Modelling (EM)
• Health Technology
Assessment (HTA)
Live projects:
• 1 – Clinical Project
• 1 – Cost & Resource use (Economic burden of disease) Project
• 1 – Health-related quality of life/Health utilities (Humanistic burden of disease) Project
• 1 – Economic Modelling Project
Courses Syllabus
Clinical Research (CR)
- New drug discovery and its Preclinical & Clinical development
- The basic terminologies applied in CR
- Overview of clinical trials
- Types of clinical trials (preventive, screening & treatment)
- Phases of clinical research (0, I, II, III & IV)
- Clinical study designs (experimental & observational) – RCT, n-RCT, prospective, retrospective, cross-sections, case study, case-series & case controls
- Blinding techniques (open-label, single-blind, double-blind & triple-blind)
- ICH guidelines (quality, safety, efficacy, & multi-disciplinary)
- GCP principles (ICH E6), 1-13
- Ethical principles (Nuremberg Code, Belmont Report, declaration of Helsinki & CIOMS)
- Centralized, Decentralized, and Hybrid trials
- Placebo & Biasness
- Responsibilities of CRA, CRC, Investigator & Sponsor
- Key steps in complete trial conduction
- Career scope in CR
Clinical Management (CDM)
- Introduction
- Importance & objectives (Data collection, Data integration & Data validation)
- Overview CDM activities
- Study start-up – CRF & Database design
- Study conduct – Data collection, CRF tracking, Data entry, Data validation, Discrepancy management Medical coding & SAE reconciliation
- Study closeout – Declaring clean file & database lock
- Regulations, Guidelines & Standard’s for CDM – ICH-E6, 21 CFR 11, SCDM & CDISC
- Tools used in CDM – CDMS
Pharmacovigilance (PV)
- Introduction and history of PV – Sulfanilamide & Thalidomide tragedy
- Basic concepts & terminologies of PV – (AE, ADR, SAE, SUSAR, abuse, misuse, off-label use, medication error)
- Key guidelines that collaborate with PV – WHO, ICH, CIOMS & GVP
- ICSR & its processing tools
- MAH responsibilities
- Challenge concepts in PV (dechallenge & rechallenge)
- Causality assessment scales – WHO UMC & Naranjo
- MedDRA, WHO COSTAT, & ART
- ADR reporting systems of different countries
- Aggregate reports
- Case studies – DSUR, PSUR, PADER & PBRER
- Opportunities in PV/Drug Safety
Medical Writing
- Medical writing introduction & types
- Medical writer’s roles and responsibilities
- Who needs medical writer?
- Regulatory writing – study protocol, clinical study reports & safety narratives
- Scientific writing – manuscripts, abstracts, posters, & slide decks
- Medico marketing writing
- Career scope
Regulatory Affairs
- Introduction, roles & responsibilities
- Drug Mater File (DMF)
- Common Technical Document (CTD/e-CTD)
- Dossiers – INDA, IMPD, NDA, MAA & BLA
