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August 2005

Paper or PKI?

DISPATCHES SAFE is a biopharmaceutical industry initiative to standardize credentials for drug discovery. It could save the industry billions. Rick Yborra doesn't like paper. Unfortunately for the senior director of global shared services for Bristol-Myers Squibb, the pharmaceutical industry's drug-approval process is besieged by it. The effort to bring a drug to market takes 10 to 12 years of rigorous testing at a cost of $1.1 billion — just to earn Food and Drug Administration approval. Forty percent of that cost is attributed to the submission, management and archiving of the 6.5 million pages of data generated during the process. Cutting down the paperwork can save time and resources in the research process — at the estimated price of $1 million a day. "Creating the initial paper documents, then having them scanned in and out of electronic systems, creates an enormous amount of friction and waste in the system," Yborra says. "If you could review and sign these documents online, and if they would meet regulatory muster, the ...

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