Three IT trends will shape the life sciences in 2012, according to an analysis by SAFE-BioPharma Association. They are the expanded use of standards-based interoperable digital identities, cloud computing in clinical trials, and the use of electronic trial master files for clinical trial management.
- 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 online 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.
- 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.
- 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,” explains Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association, 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.