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COURSES WE OFFER

CLINICAL RESEARCH/CLINICAL TRIAL MANAGEMENT

  • ➔ Clinical Research History
  • ➔ ICH GCP Guidelines
  • ➔ Pre Clinical Research
  • ➔ Pharmacovigilance
  • ➔ Protocol

Phases:

  • ✔ Phase I
  • ✔ Phase II
  • ✔ Phase III
  • ✔ Phase IV

Trail Design:

  • ✔ ARMS
  • ✔ Randomization
  • ✔ Blinding
  • ✔ Parellel
  • ✔ Crossover
  • ✔ Interpretation of Time & Event Schedule
  • ➔ E2A Guidelines
  • ➔ E2B Guidelines
  • ➔ Investigator Brochure
  • ➔ Inform Consent
  • ➔ Source Documents
  • ➔ LOGS
  • ➔ Trial Master Files
  • ➔ Ethics Commitee
  • ➔ Site Feasiblity
  • ➔ Site Initiation
  • ➔ Site Monitoring
  • ➔ Site Close Out
  • ➔ Roles of Investigator, CRC, CRA, Sponsor
  • ➔ Walk Through the Steps from Subject Recruitment to Subject Completion of Study with Real Time Scenario's.

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