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>Clinical Trial
Actelion Pharmaceuticals Ltd is a biopharmaceutical company. Founded in 1997, Actelion is leading player in innovative science related to the endothelium. Actelion focus on discovery, development and marketing of innovating drugs for significant unmet medical needs. That’s why clinical trials are crucial in the development of its drugs. The Case Report Form (CRF) is central to these trials but processing the CRFs in the traditional way is not efficient and costly.
Developed to speed up the completion of routine forms, FAS consists of an end-to-end solution including CRF printing, Digital Pen and Clin’ Form®- server software application allowing a seamless integration into Actelion’s web data management application. Using FAS is quicker and cheaper than the traditional method and it also provides Actelion’s monitors with real-time information on results or problems before they visit the trial site. Increasing efficiency and saving time during development extends the market life of a drug that could subsequently add millions of dollars to sell.
•Company Name: Actelion Pharmaceuticals Ltd
• Project: Two Phase I clinical trials using FAS (Forms Automation System) based on Digital Pen and Paper technology to fill in CRF.
• Results: The two clinical trials were a great success and full-blown patient trials are now to be conducted in hospitals.
• Benefits: The ink and paper approach enables to keep similar speed in data connection, avoids the burden of data entry at the investigational sites and simplifies the validation requirements and the training process. FAS enables to save time, to bring a drug to market earlier which would be to the benefit of the patients. Thanks to FAS, you have a longer time on the market before the patent runs out.
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