Data Management | E-Tools

/Data Management | E-Tools
Data Management | E-Tools Emmanuel Sanchez 2018-04-11T14:39:13+00:00

DATA MANAGEMENT | E-TOOLS

Skilled and regularly trained in Data Management, in Clinical Research, ITEC Services Data managers use Ennov Clinical®.

Information Safety and compliant data protection and privacy

Data hosting

Data management documents preparation

  • Data management plan
  • Data validation plan
  • Annotated CRF
  • eCRF specifications

Data collection system set up (input masks, consistency checks…), eCRF/ePRO/IWRS

Data collection system validation

Database translation

Production DataBase Release

Adjustments control / Incidents management

User management

Data validation

  • Consistency checks program
  • Listings validation edition and review
  • DCF edition and upload
  • Obvious corrections resolution (if relevant)

Data coding

  • Coding
  • Coding listings validation

Monthly reconciliation of pharmacovigilance cases collected with the pharmacovigilance database

  • Preparation of the study base extraction
  • Pharmacovigilance database extraction
  • Extractions differences review
  • Report (differences, actions to do)
  • Actions realization and follow-up
  • Study database update (if relevant)

Final reconciliation of pharmacovigilance cases collected with the pharmacovigilance database

Data review

Base freezing (intermediate or final)

Data management report

Data transfer at the end of the study