Biopharma cozies up to digital IDs

Look around and you'll see that trust in electronic signatures is growing. And the evidence is not just growth in users, but also in the types of user organizations and their reasons for use.

"CROs are using it as a competitive advantage, a way to get studies going more quickly," explains SAFE-BioPharma Association CEO Mollie Shields-Uehling. Near instantaneous electronic communications, document exchange and regulatory submissions sidestep the cost and time involved in paper transfers. Digital signatures are considered a step above electronic ones in the security they provide.

Shields-Uehling notes in an interview at last week's DIA show in Washington, D.C. that some of SAFE-BioPharma's members now require their external partners to begin using the association's standard for digital identity verification. Some big pharma companies are using it for regulatory submissions, and the National Cancer Institute uses it to initiate contracts with partners, she says.

A digital signature is more defensible in court than other forms of electronic signatures, according to privacy and data security lawyer Randy Sabett of Sonnenschein Nath & Rosenthal. No cases have tested digital signatures yet, he says. But there have been cases concerning electronic signature fraud, in which one person masqueraded as another. That breach stemmed from process problems with the administration of the signatures, and not the signatures themselves, Sabett says.

The SAFE-Bio-Pharma standard, says Shields-Uehling, includes measures that protect against such process issues.

She also notes that many of the regulators in developed countries accept or will soon accept digital signatures. However, those in lesser developed countries may not have the required infrastructure. The association is working with regulatory bodies throughout the world, she adds, so drugmakers "won't be required to have different sets of digital identity systems for different regulators."