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Paper Electronic Data Capture is both traditional and revolutionary

Traditional in its use of pen and paper, revolutionary in its source traceability, data integrity, electronic data capture effectiveness and speed of data transfer.

The digital pen produces a traditional paper record whilst faithfully recording every pen stroke, together with its precise time and date, as the user fills in a form or makes notes in a daybook.

When the user has finished writing, the data in the pen’s memory is uploaded to a computer system by docking or via mobile phone. The system stores a record of all the pen strokes (including their time and date stamps) and creates an image of the paper document. Handwriting is automatically converted to XML ready for verification, validation and subsequent output to the clinical data management system.

Paper EDC has a number of unique features ideally suited to the clinical investigations environment:

• the system provides complete data security and integrity, from the digital pen to the data archive.
• The solution applies a unique dot pattern to every CRF or page of a notebook for the electronic pen to read. With the pattern on no two pages alike, and every page identifiable by the computer system which produced the pattern, complete historic traceability is readily achieved.
• The form printing process includes the ability to pre-fill digital forms with subject data from clinical trials management systems, enhancing data quality and making life easier for the user. .

The digital pen solution is convenient, simple to use, easy to deploy and gets data back for analysis in real time.