By Mollie Shields-Uehling, President and CEO,
SAFE-BioPharma Association
As a global standards organization, SAFE-BioPharma has a unique perspective into developing and future IT trends in the life sciences, especially as they relate to use of our global digital identity and digital signature standard. Our staff works closely with member companies which are using the standard in a growing range of applications. We also work closely with non-member organizations to help them develop proof-of-concept studies and pilots utilizing the standard.
Based on these activities we have been able to identify three IT trends that will shape the life sciences in 2012.
1. STANDARDS-BASED INTEROPERABLE DIGITAL IDENTITIES
Industry leaders are rapidly increasing use of these unique digital identities among employees, collaborators, and clinical investigators. Issued once every three years, they take the place of multiple on line identities and can be used to control access to information and physical facilities. They also provide the ability to apply legally-binding digital signatures to electronic documents. The benefit of interoperability is that the digital identity is recognized and accepted by US government agencies, by other companies
2. CLOUD COMPUTING IN CLINICAL TRIALS
As demonstrated in a study between the National Cancer Institute and company-based cancer researchers, significant time and cost savings are realized when trial-related documents are accessed from the cloud rather than delivered by courier or mail. Interoperable digital identities (NCI researchers using government provided digital credentials; company researchers using SAFE-BioPharma digital credentials) give researchers access to the cloud-based electronic documents as well as the capability to apply legally-binding digital signatures. (Read The Paperless, Cloud-Based Clinical Trial; It’s Happening Now )
3. ELECTRONIC TRIAL MASTER FILES
Trial Master Files – the central record containing the files associated with clinical trials – are one of the last areas where clinical development records are primarily paper-based. Multiple pilot studies scheduled to start in the next few months indicate that pharmaceutical companies are preparing to make the process electronic. Companies will use SAFE-BioPharma digital identities to manage access to documents and to provide participants with the ability to apply legally-binding digital signatures.
The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development is managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org/.
Mollie Shield-Uehling is President and CEO of SAFE-BioPharma Association. In this role she directs the business and strategic activities of SAFE-BioPharma Association. She has more than 20 years of international trade and biopharmaceutical industry experience. She is a member of the association’s Board of Directors.