Data Management

OPIS applies standardized and established data management processes to ensure integral, analysable data and real-time availability in a secure and protected environment.

  • EDC Platform(*)
  • Study design
  • eCRF/database creation (customized to company requirements)
  • CDISC Standards
  • IVRS/IWRS set-up
  • Edit check implementation
  • Query management
  • Data cleaning
  • SAS Programming
  • Listings and Patient Profile creation
  • Data review
  • Project status and metrics reports
  • Medical coding
  • SAE reconciliation
  • Protocol Deviation management
  • Drug management
  • Safety management
  • Laboratory management
  • Third-party data handling
  • ePRO
  • Reports
  • Training and Technical Support

All our procedures are ICH/GCP and GDPR compliant

(*) is an OPIS brand and was thoughtfully created as a solution to manage clinical trial data in a complex international environment.

Systems are FDA CFR Part 11 compliant and ISO 27001:2017 certified, all user-friendly modules are customizable and external sources of data are easily integrated.

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Whether you are Sponsor, a Clinical Research Professional or an Investigator contact us to learn more about how we can help.

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