From Mesopotamia to Cyberspace

By Mollie Shields-Uehling, President & CEO,
SAFE-BioPharma Association

Cylinder seals used in Mesopotamia are one of the earliest known forms of authenticating identity. Dating to 3000 BC, cylinder seals were used to make documents legally binding and to assure the owner’s identity. They were hand engraved, and, when rolled on wet clay, left a unique and often elegant picture. Each imprint was associated with an individual and became a sign of trust. Collections of these tiny works of art can be seen in New York’s Morgan Library, the British Museum and the Louvre.

Authentication has taken a new meaning in our cyber-centric business culture – especially in regulated industries like biopharmaceuticals and healthcare.

To benefit from our new web-based interconnectivity, we must know – beyond doubt – the identities of each and every person with whom we’re conducting business.

That’s where the SAFE-BioPharma digital identity standard plays its critical role.  The standard requires each digital identity to be closely linked to the user’s proven identity. That information is used in a digital credential — a form of software installed on a computer, cell phone or other device. The digital credential asserts the user’s identity and can be used to apply digital signatures to electronic documents

These are not simple electronic signatures. SAFE-BioPharma digital signatures cryptographically guarantee the integrity of every bit of information contained in the document.

The identities also are interoperable, meaning that they can be trusted by people in governments, in other companies and in other industries.

This combination of factors – trust, interoperability and the ability to sign electronic documents in a legally-binding way – has made identity credentials based on the SAFE-BioPharma standard critical where used.

But use of these digital credentials needs to expand for the biopharmaceutical and healthcare communities to realize greater time and cost savings.

The clinical trial start-up process is one of many areas that can benefit. To prove the point, SAFE-BioPharma member company, Bristol-Myers Squibb (BMS) and the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI/CTEP).are well along in a pilot study demonstrating the elimination of paper forms and letters used when initiating clinical trials.

NCI/CTEP is the world’s largest sponsor of cancer treatment clinical trials. In 2010, it generated documents comprising almost 100,000 pages to develop and correspond in its clinical trials.

While the unit does not track the time involved in scanning, organizing and sending these paper documents to the FDA, it reports that it is extremely labor intensive.

The pilot study was started in July, 2010 to demonstrate the ability of both public and private sectors to sign and exchange documents digitally in the cloud, thus eliminating any need for wet signatures and, therefore, any need for paper.

BMS researchers used their SAFE-BioPharma digital identity credentials. NCI researchers used digital identity credentials issued by the federal government. Both types of credential are interoperable.

There were dramatic time savings for all document flows that require multiple signatures or signatures from signatories working off-site. There were no lost or misplaced documents. Because cloud-based digital signatures were used, there was an audit trail of when the document was uploaded, of the email that was sent to alert the signatory that the document is available for signature, and when the document was actually signed.

By eliminating paper-reliance, BMS and NCI saw the possibility of reducing environmental impact associated with use of paper and ink, document shipment, storage and retrieval.

What is the future bottom line of this improved business process flow? NCI and its collaborators can speed up research and be more responsive to public health needs.

Recently, researchers from sanofi-aventis, another SAFE-BioPharma member, joined the pilot and are signing and exchanging electronic documents with NCI, using their SAFE-BioPharma digital credentials. Before long, researchers at several university-based cancer centers will participate, as well.

Just consider what this will mean when lessons from this study migrate to other companies and to the CRO community.

We’ve come a long way since the days of authenticating identity with cylinder seals and wet clay. Today, interoperable digital credentials allow electronic documents to be signed anywhere there’s an Internet connection and to be exchanged with trust.

Finally we can become paperless.  Come to think of it, the Mesopotamians didn’t use paper either. Paper wasn’t invented until 105 AD.

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