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Digital Pen and Paper Technology Helps Accelerate Clinical Trials

The ongoing challenge in drug development and clinical trials is to capture and document data accurately. The goal is to complete the process of viewing, cleaning, analysing and coding the data as fast as possible, ultimately with the goal of bringing a fully-tested new drug to market quickly.

With clinical studies often taking anything from several weeks to years to complete, vast amounts of data need to be collected. Traditionally, this data had to be entered manually into IT systems for further processing and analysis.  Digital Pen and Paper technology from Anoto has been shown to significantly speed up the capture of trial data, and help accelerate this process.

Digital Pen and Paper automatically converts handwritten notes in clinical trial forms into keystrokes, avoiding the time-consuming manual data entry altogether.

The digital pen looks like a ballpoint pen. A tiny infrared camera at its tip tracks its movements relative to a grey dot pattern printed on the form, recording and storing what is being written. When investigators have finished gathering data, they place the digital pen into a USB docking station to synchronise the pen with backend IT systems. Alternatively, data can be transmitted via a Bluetooth-enabled mobile phone. As a result, clinical trial data is available immediately for processing and analysis.

No changes to workflow

The greatest advantage of the technology is that handwritten information can be digitised without any changes to existing work routines, and that a high level of data accuracy can be achieved. Users continue to fill in forms with a pen, as before. In this way, the advantages of paper are retained, for instance its ease of use, the ability to archive information easily and its original content, which is often needed for legal purposes. Likewise, users do not have to be trained to use tablet PCs, PDAs or scanners.

This in turn means that Clinical Research Organisations (CROs) can realise time and cost savings, as well as avoiding manual data entry errors. Studies have shown that digital data capture using Digital Pen and Paper is superior to alternative solutions such as laptops, PDAs or tablet PCs. Data entry error rates are close to zero, all while realising time savings of up to 60%. This was confirmed by a study published on the occasion of the World Usability Day 2008 (Boldt R, Raasch J, Hamburg 2008).

As the inventor of Digital Pen and Paper, Anoto makes its technology available to a worldwide network of partners who design tailored, industry-specific Digital Pen and Paper solutions.

In the pharmaceutical sector, the technology has a proven track record in areas such as the collection of patient data and documenting the progress of clinical trials.

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