Even in a global clinical trial, driven by 21st century medicinal chemistry, gene arrays and relational databases, there is a medieval component. A stubborn one.
Thousands of pieces of paper, each with a squiggle at the bottom. Signatures. John Hancocks. Squiggles mean the paper has to be pushed like sausage filling into some other system. Filed. Scanned. Stored. Shredded.
Is the pharmaceutical industry serious about efficiency? Then how to explain that fax machine down the hall? What role does it serve, except to send or receive a squiggle?
The SAFE-Biopharma Association has been trying to kill the paper signature. The organization has given itself until 2012 to nudge the life sciences toward “a fully electronic business environment,” as the SAFE-BioPharma website states. We’re not sure a fully electronic clinical trial environment will be possible in the year 3012.
But to find out how its effort is going, we checked in with SAFE-BioPharma’s president and CEO, Mollie Shields-Uehling. (She’s not related to this website’s editor.)
What is SAFE-Biopharma? A nonprofit set up by big pharma. Its goal: To get people to sign business documents with electronic bits, not ink. Just as trains blossomed when the rails were one standard width apart, the SAFE philosophy is that the pharmaceutical industry will become more efficient with a single method to sign documents electronically.
Shields-Uehling explains what adherence to the SAFE-Biopharma protocol allows. “You and I can never meet. We can sign a contract that will be legally binding. We can trust the identities and we can do business. It is legally recognized. It is global.”
SAFE-Biopharma has a new relationship with the National Notary Association that allows drug companies to quickly establish someone’s identity. There are also methods to accomplish the same thing for hundreds of people at a time, on the enterprise level. “You would just upload the names and addresses of the 500 employees, they would go online and get credentialed,” she says.
The organization has also debuted a roaming digital identity that allows someone to use any computer on earth to establish his or her identity. That approach relies on a fortified USB drive to supply the heavy-duty security and math that has to unfold behind the scenes.
And Shields-Uehling says SAFE-BioPharma has also been accepted into a key U.S. government electronic signature network. The FDA, National Institutes of Health, Dept. of Justice and other major federal agencies are tied into the system. There’s a news release on the SAFE-BioPharma site, and this organization has more information.
She thinks the federal effort on electronic signatures will come to matter as more data from the health care system potentially becomes usable, in deidentified form, by researchers. “The government is going to collect lots of information about medicine, health treatments, about medical devices, about clinical practice and hospitalization,” says Shields-Uehling. “They are going to take that information, analyze it and make it available to payers and the public. In that process, you need some security.”
There are three ways to embrace SAFE electronic signatures. Johnson & Johnson and Bristol Myers-Squibb built their own systems from scratch; other companies use vendors; and the SAFE BioPharma Association can help. (It can call for backup from consultants at SAIC). “We’re the highway,” says Shields-Uehling. “You can drive a Ford. You can drive a Mercedes. You can drive a Mack truck. You can drive anything you want. It doesn’t matter.”
The members of SAFE-Biopharma have worked out the technical specs so that 20-some vendors can handle the details of helping companies use the SAFE signature standard. The roster includes IT goliaths like Adobe and IBM and lesser-known signature specialists like nCpher and xyzmo.
Shields-Uehling is agnostic about how the electronic signature is implemented. “We have this network of communities that can trust each other and do online transactions with high trust and high confidence,” she says. “We don’t care who your vendor is,” she says. “We want [the standard] used.”
Roots of Resistance
The industry is coming along, with most of big pharma supporting the initiative to varying degrees. Proctor & Gamble, Pfizer and other firms have stopped using paper in their discovery operations, moving to electronic laboratory notebooks. Astra-Zeneca does all its regulatory submissions electronically, and all of them use SAFE signatures. (This download is a white paper on the project.)
“There is a growing realization that the industry needs and wants to move away from paper,” Shields-Uehling says. “There are very substantial gains in terms of the environment.” The ecological aspects of electronic signatures, we would guess, could be an easy public relations win for companies noting their participation in the SAFE-BioPharma effort.
The main reason for electronic signatures, of course, is the under-appreciated expense and responsibility around having to touch one regulated piece of paper, let alone millions of them. In an age of shared documents, “wet” ink signatures are outdated, like quill pens. As Shields-Uehling concedes: “What is the barrier is the whole change management process.” One’s own squiggle retains allure, it appears, even in an ethernet age.d9A2t49mkex