How is digital pen technology used in clinical trials?

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Getting approval for a new drug is a lengthy and complicated process. Extensive tests must be carried out in order to assess the safety and effectiveness of the product and this inherently requires the collection and recording of large volumes of data. At the same time, however, the timescale within this can be done, is critical – the sooner the new drug is approved, the earlier it can be used to cure a patient, start to earn revenue and also stay ahead of other competitive pharmaceutical companies.

Another consideration is the confidentiality and security of the data collected and the ability to share it with ‘Monitors’ who are people paid by the pharmaceutical company to review the data.

So, how can the digital pen help? During clinical trials each patient is given a series of forms which are to be completed by a doctor. These forms can be printed on to ‘Anoto’ paper with unique pattern and the doctors would use a digital pen to record the data on the form. The data is uploaded and processed daily and is made available to the ‘monitors’ to view prior to a visit, which enables them to highlight any areas for correction or further investigation. This not only saves time but also reduces the number of visits required and the high cost of travel expenses.

Doctors do not have to learn new technology – they continue to write with a familiar object, i.e. a pen, savings are made on transcribing the information but more importantly the ability to get the new drug to market quicker than before can mean savings of millions of pounds.

For more information on digital pen technology, please call The IPC Group on 08081 45 46 47.

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