Large biopharma companies are driving the use of digital signatures among contract research organizations, says Safe-BioPharma CEO Mollie Shields-Uehling. One example: IPS Research, driven by GlaxoSmithKline's implementation of the digital identity and signature standard for its clinical trial contracts.
Shields-Uehling reports on the IPS effort and other developments in the just-published Safe-BioPharma Association Midyear Update.
The 14-page electronic document includes also a description of the joint pilot being conducted by Bristol-Myers Squibb and the National Cancer Institute. The goal of the pilot is to demonstrate an all-electronic workflow that includes digital signatures and use of the Federal Bridge--large-scale government and other public key networks linked by certification paths--all in an attempt to speed up drug time to market.
In the pilot, the collaborators use digital signatures to authenticate reviewer, approver and signers of such documents as letters of intent, concept approval, protocol approval, and clinical trial agreements and contracts.
- see the report