Fully customizable modular framework completely developed by OPIS is an OPIS brand, thoughtfully created as a highly customizable e-solution. From project design to database lock, the proprietary software enables proactive study start-up management, direct electronic entry, information retrieval, and data analysis thus ensuring complete transparency across a project’s lifecycle.
The system is web-based and fully FDA 21 CFR part 11 compliant.

The main modules are:

  • Electronic Case Report Forms (eCRFs) in different languages and Clinical Data Management
  • Study Drug supply management
  • Serious Adverse Event (SAE) data collection and notification
  • Electronic Patient Reported Outcomes (ePROs)
  • Integrated IRT
  • Electronic Learning platform (e-Learning)
  • Protocol deviation assessment
  • Online medical terms coding (MedDRA and WHO)
  • Compassionate Use Programs management
  • Data import from external sources
  • Real-time reporting
  • Integration with external systems modules can operate as standalone services or can be integrated in a Study Portal with single point of access.

The following modules are available in the (EDC) Study Web Portal

  • eCRF
  • IRT
  • e-Learning
  • Protocol Deviation
  • Product Management
  • eSAE
  • ePRO


To plan your clinical trial, to schedule a demo or receive more information, please complete the contact form.

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