FLeX EDC

 

Web-based data capture

 

Lambda-Plus FLeX+ EDC is a fully validated ICH GCP and FDA 21 CFR part 11 compliant web-based data capture tool.

ECRF is available through an extremely intuitive and user-friendly interface: FLeX+ EDC is the data capture technique most appreciated by end-users.

Data capture is accessed through a completely secure e-Platform that is used to display the content differently, according to the user’s profile, whether that user is a physician-investigator, project coordinator, CRA/Monitor, data manager etc.

Collected data can be monitored on-line and, thanks to full integration with other Lambda-Plus EDC solutions (IWRS/PRO), direct access to the whole set of patient data is made possible (pooled into one single database).

Multiple notifications can be generated by the e-Platform in order to improve patient follow-up (e.g. if AE is reported or as soon as a new patient is screened).

 

Key Features

  • Lambda-Plus proprietary system
  • Meets the highest quality standards
  • Intuitive solution allowing very limited training of end-users
  • Customized eCRF and e-Platform
  • Integrated on-line randomization (IWRS) linked to drug supply management
  • On-line monitoring and query management by the CRAs/Monitors/DMs
  • Inconsistencies and queries highlighted in eCRF for easier detection and action
  • Multiple automatic notifications enabled, incl. notification of side effects to pharmacovigilance department
  • Access to profile-dependent on-line reports
  • Seamless integration of external data sources and systems.
  • Multi-language capability