Version control is also a big one for the pharma industry. The way things are usually done is documents are scanned and submitted via CD’s or other electronic media to the FDA. But the source copy is still paper and this paper needs to be stored for a very long time.
But, as additions are made to the company’s knowledge of a drug, for example, all that stored source paper has to be kept up to date. So, while companies may work electronically, they are still bound to millions of pages of paper.
SAFE eliminates this. By allowing for electronic signatures, all documentation can be kept in digital form, negating the need to reconcile paper and electronic copies.
And this is where the money comes in. To develop a new drug today costs, by some estimates, somewhere between $850M and $1.2B dollars. Thirty-to-40% of that cost is paperwork, said Donfried. By freeing up the industry from all this paper, millions of dollars in savings can be realized.
“Once a pharmaceutical company has this completely deployed within their development organization there appears to be the potential to reduce or eliminate about 30-to-40% of that cost structure,” he said. “You’re not going to realize those savings until it’s end-to-end.”
But the Astra filing is a important first step — for all businesses, said IDC’s Hudson.
“The insurance industry is going to sit up and take notice. I think different aspects of the medical community, certain international banking, finance — any place that has to transmit a lot of different information among different entities … of a very sensitive nature, they’re going to save a lot of money and time if they can do this electronically and securely,” she said.