Electronic Data Capture

eCRF design, using standard CRF modules, also controls database construction. The eCRF is a facsimile of the paper CRF, retaining familiarity and corporate standards. Investigators and research nurses give us very positive feedback.

The system is hosted on a remote, secure and mirrored server environment and access is via the Internet using hierarchical password control. All data are encrypted. The Sponsor can assign user privileges.

Data can be browsed in real time, or downloaded into spreadsheet format to facilitate review. We can program tailored reports, which are automatically generated at predefined intervals.

The system comes into its own when there is high priority for data turn-around. We have been using it, for example, in ascending dose Phase I studies, when safety data reports can be generated in real time, on demand.

We can receive and integrate electronic data from other sources, for instance laboratory data, electronic diaries, ECGs etc.

The system not only allows speedy completion and presentation of data at the end of the process; eCRF creation and database build can be completed in less than half the time that conventional methods allow. If global pages and validation rules are used, all information can be held in a library allowing even more rapid set-up time for subsequent studies.

Syne qua non | data management | electronic data capture | statistics
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