Our eCRF system is a user-friendly, web-based solution that integrates all aspects of remote data collection, data management, patient monitoring and ongoing analysis within one robust system.

It has been developed with two key factors in mind:

  • Ease of use
  • Powerful data verification via automated processes

Comfortable data entry

  • eCRF system data capture is very intuitive.
  • Screens are dynamic to prevent data entry errors.
  • The site user can link a concomitant medication with the related adverse event, or for example link a clinically significant abnormal laboratory result with the corresponding adverse event.
  • Navigation within a patient CRF is protected by the auto-save option. Any data entered is saved as soon as the user leaves a CRF page, even if a manual save has not been performed.

Revolutionary query management = Highly time and cost efficient

  • All queries, from the simple ones to the most complex cross-page consistency checks, are automatically generated and emitted in real-time.
  • The queries do not need to be reviewed by a data manager before emission. This is often done to avoid asking the site to answer several redundant queries. Our eCRF resolves automatically and in real-time all redundant queries. A corrected value automatically eliminates all queries that are linked to that correction!
  • The tedious, costly and risky work of manually eliminating redundant queries belongs to the past!
  • Queries can be answered directly on a CRF page, or in a specific, user-friendly query window. It allows the user to browse easily between the pages addressed by the query. The concerned fields on the CRF page are highlighted.

Smart implementation of manual queries

  • Data managers or trial physicians have access to a system of listing cross-checks for controls that cannot be performed by a computer. They manually review listings and have the possibility to send pre-defined query message if an anomaly is detected in the data. The work can be done on an ongoing-basis and the system is only showing new cases or cases modified by the site.
  • Manual queries can be emitted by the CRA or Data Manager.
  • Ask us for more information about our specific and very efficient management of SDV related queries! Your CRAs will be pleasantly surprised!

Other features

  • Our eCRF is fully integrated with our IRT system, in a common website and a common study database.
  • Data integration with central labs or central readers. All laboratory results, together with units and normal ranges, are transferred in real-time to the eCRF and are available in read-only mode to the site users. The only thing the site user has to enter is the clinical or non-clinical significance of abnormal lab results. This reduces data entry and data management effort.
  • AE and concomitant medication coding module included.
  • Data transfer in accordance with client standards and CDISC. Data transfer to SAS is easy and does not require formatting.