Paperless clinical trials have received high-level support in recent months from IBM, Adobe Systems, Arcot Systems, CoreStreet, Kyberpass and nCipher, all of which have agreed to create products around the digital signature standard developed by the SAFE-BioPharma Association of pharmaceutical companies. (Members of the association include Pfizer, Merck, and GlaxoSmithKline.)
Once SAFE technology is in place, doctors, clinicians, researchers and service providers will be able to obtain a single, universal digital credential that will be recognized across a pharmaceutical e-communications network and provide authentication and digital signing of documents used in clinical trials.
Before SAFE, a doctor at a research university might have four different laptops with four different hardware tokens containing four credentials, requiring four passwords, one for each of the clinical trials she's working on. With SAFE, the doctor could use one laptop and one credential for all the trials. The digital credential also could be used for other purposes, such as to give the physician access to pharmaceutical portals to order drugs.
"With approval from the Food and Drug Administration, clinical trials using the SAFE credential eventually could go completely paperless," says R. "Doc" Vaidhyanathan, vice president of authentication provider Arcot. The National Cancer Institute and the European Medicines Agency have committed to adopting the standard.
Initial trials of SAFE started in mid-2005. The experiences of these trials are being applied to modify the processes and software used in real-life clinical trials.
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