Electronic data capture : clinical data quality

Digital Pen and paper, electronic data capture solution for handwritten clinical data

The best data quality

• Data entry in a secure and reassuring (paper and pen) setting enhances form completion precision and the quality of the collected data. The daily work habits of users are not disturbed and they trust the information collection solution.
• A study by the Public Hospitals of Paris (AP-HP), conducted by Professor Philippe Ravaud (Department of Epidemiology, Biostatics and Clinical Research at INSERM) on the quality of data entered during clinical trials demonstrated that the use of paper and pen remains the best method for entering information.

Complete electronic traceability

With a unique pattern allocated to each form, to the pen’s unique identification number and to its timestamping function, complete traceability of users and actions is ensured. The Kayentis solution allows true notarization of the processes:

• Form treatment monitoring by user and by date makes it possible to keep a precise trace of persons who completed a given form, and the precise moment when the forms were processed or updated.
• Detailed traceability makes it possible to maintain responsibility and the precision of historic data. It facilitates controls and checks from the time the information is entered.
• It also allows the paper source to be stored as a probative value while establishing immediate electronic archiving of forms and documents.

No revolution or training for users

The implementation of the Kayentis solution does not change user habits, and it adapts to all processes and organizational modes.
The capture devices (digital pen & paper) require very little training. At Eurocopter, it took just one hour for users to feel comfortable with the solution.

An immediately perceptible ROI

Beyond the immediately perceptible benefits for an organization using the Kayentis solution, in particular when it is subject to strong compliance requirements, it is easy to calculate the solution’s ROI if you take two factual aspects tied to its use into consideration:

• The absence of data re-entry or paper form scanning by operators. Their role simply consists in approving data supplied by the system for which there are doubts.
• Reduction of user training to its simplest form. By using the Kayentis solution, it even happens that for clinical trials, the patients themselves complete the clinical books (study conducted by Pierre Fabre on rhinitis in March 2007)
• Optimization of costs tied to the use of paper forms: possibility of printing documents on demand, and of modifying forms dynamically.
• Easy, fast deployment of the solution on multiple sites

The savings in labor are therefore fully quantifiable and in themselves justify use of the solution.