Clinical Data Management(CDM) and Safety Risk Assessment(SRA)

Heptronik is providing training on Clinical Data Management(CDM) with hands-on experience with State-of-art EDC/RDC application, Safety Risk Assessment/Management.

Clinical Data Management Course Content

  • Pharmaceutical Industry Overview
  • Clinical Data Management process
  • CRF design and Common Data sets
  • Managing Lab Data/PK data
  • Validation/data Import/Export/Reporting
  • Database Lock/Freeze
  • EDC an RDC experience
  • SAS programming basics to perform edit check/validation


Safety Risk Assessment

  • Pharmaceutical Industry Overview
  • Post-marketing safety analysis
  • Clinical Trial Safety
  • 360 degree analysis of AE/SAE/Lab/ECG/Dose/Conmeds/Medical/Surgical dataset
  • Developing analysis reports


Click here to Register with us for training.