Conventional data collection for clinical trials traditionally focused on paper-based case report forms (CRF) followed by double data entry into a relational database. Electronic data capture (EDC) systems represent an intriguing alternative, which allow investigators to enter and to review data in real time and to implement on-line data validation checks, thus assuring data quality more effectively at the point of entry.

CLADE-IS (Clinical Data Warehousing Information System) belongs to the class of the most modern and progressive EDC systems. It comes with EAV data-model of the database (Entity–Attribute–Value model), which allows to switch quickly between various topics and clinical fields where data needs to be collected, verified, analyzed and visualized on-line. The inherent data-access model is robust enough to allow countless configurations of user privileges, roles and data flow. In the default configuration, the following user roles are recognized inside CLADE-IS: (i) investigator, (ii) site manager, (iii) regional coordinator, (iv) data manager, (v) monitor, (vi) administrator.

With the use of responsive webdesign, CLADE-IS provides its users with an easy and ergonomic interface. Navigation and reading require only a minimum of resizing, panning, and scrolling; a wide range of devices can be used: from desktop computers to tablets and smartphones. CLADE-IS works in the majority of available web browsers; there is no need to install any other software. It is recommended to use only up-to-date browsers running on up-to-date operation systems.

Only authorized users – based on their login and password – can access the interface of CLADE-IS. The registered data is anonymous: for each patient/case, a unique ID is always generated. The communication between CLADE-IS and its users is encrypted with the use of SSL (Secure Sockets Layer).