A course is a set period of study or training

Our Courses Clinical Research Courese

Course 1

2 Month Couse

18,000/-

Advanced Interview-Oriented Skill Development Certification Course In CR, CDM, PV, MW & RA

Course 2

3 Month Couse

₹21,000/-

Advanced Interview-Oriented Skill Development Certification Course In CR, CDM, PV, MW & RA

Course 3

3 Month Couse

₹27,000/-

Advanced Diploma Certification Course In CR, CDM, PV, MW & RA (100% Placement within 3-4 Months)

Course 4

6 Month Couse

₹51,000/-

Advanced Integrated PG Diploma Certification Course In CR, CDM, PV, MW & RA (100% Placement within 6 Months)

HEOR COURSES

1,25,000/-

Live Project Based Advanced PG Diploma

CertificationCourse in HEOR (RWE, SLRs, NMA, EM & HTA)

Courses Syllabus

Clinical Research (CR)

  • New drug discovery and its Preclinical & Clinical development
  • The basic Pharmacological terminologies applied in CR
  • Overview of clinical trials
    Types clinical trials (preventive, screening & treatment)
  • Phases of clinical research (0, I, II, III & IV)
  • Clinical study designs (experimental & observational)
  • 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)
  • 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
  • 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 – Thalidomide tragedy
  • Basic concepts & terminologies of PV
  • 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
  • ADR reporting systems of different countries
  • Aggregate reports
  • Case studies
  • 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

Departments

CLINICAL RESEARCH (CR)

5/5

CLINICAL TRIALS (CTS)

5/5

CLINICAL DATA MANAGEMENT (CDM)

5/5

PHARMACOVIGILANCE (PV)/DRUG SAFETY

5/5

MEDICAL WRITING (MW)

5/5

REGULATORY AFFAIRS (RA)

5/5

REAL-WORLD EVIDENCE (RWE)

5/5

SYSTEMATIC LITERATURE REVIEWS (SLRS)

5/5