eClinical software suite

If you are a sponsor, CRO or academic research institution of any size, you will benefit from our powerful eClinical software suite when conducting your clinical studies.

Our eClinical system includes:

  • CDISC-certified EDC (Electronic Data Capturing, eCRF)
  • CDMS (Clinical Data Management System)
  • PROMs (Patient Reported Outcome Measures)
  • CTMS (Clinical Trial Management System)

Regulatory compliance

We offer a fully GCP and ISO compliant software package.

The software has been designed according to GCP and applicable ISO guidelines and complies with all relevant FDA regulations, in particular with 21 CFR Part 11.
End-to-end processes for clinical data management including trial set up, implementation and archiving are all fully supported by our system.
This optimised IT infrastructure together with reliance on workflows defined to optimise operational strategies is paramount to effective and resource-efficient conduct of your clinical research activities.

Ergonomic and intuitive eCRF

Any web-connected computer or tablet will do!

The platform is set up for on-line data input on an ergonomic and intuitive eCRF. Any web-connected computer can be used to access the study through the eCRF. It is compatible with all common operating systems and browsers. Moreover, the eCRF is accessible through mobile devices (tablets).

The system has PROMs functionalities. Patients can document their outcome on an online platform that is accessed through a web browser. Key offerings:

  • Real-time data
  • PROM functionality: “Patient-as-User”
  • Custom analytics & reports
  • Ad-hoc reporting
  • Risk-based monitoring
  • CDISC and CDASH standardisation
  • CRF annotation and review
  • Edit checks programming and testing
  • Data validation specifications
  • Query management
  • Medical coding
  • Safety data management