The Paperless, Cloud-Based Clinical Trial; It's Happening Now

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

Interoperable digital identities are poised to help the global biopharmaceutical industry harness the full power of cloud computing. One major outcome will be more efficient and less costly clinical trials.

An ongoing study involving cancer researchers at the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI/CTEP) and counterparts at Bristol-Myers Squibb and Sanofi provides a window into the future of this process.

NCI/CTEP is the world’s largest sponsor of cancer treatment clinical trials. In 2010, it generated almost 100,000 pages to get clinical trials underway.

The study eliminated paper from the clinical trial start-up process by placing documents in the cloud and giving the researchers access using their digital identity credentials. These credentials also gave the researchers the ability to apply digital signatures to the electronic documents.

As a result, dramatic time savings occurred for all document flows requiring multiple signatures or signatures from people working off-site. 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 was available for signature, and when the document was actually signed.

The success of the study was based on the use of digital identities that are interoperable. Interoperable digital identities also will be at the foundation of future cost and time savings in the entire clinical trial process.

By way of explanation, these identities are digital credentials that are closely linked to the user’s proven identity and installed on a computer, cell phone or other device. They become interoperable when the entities that issue them have gone through a process that assures they can be trusted by governments, in other companies and in other industries.

That’s where the SAFE-BioPharma digital identity standard plays its critical role.  The standard — developed by a consortium of biopharmaceutical and related companies with participation from the US Food and Drug Administration and the European Medicines Agency – provides standardized ways to manage and verify digital identities and to apply legally binding digital signatures to electronic documents.

Unlike simple electronic signatures, SAFE-BioPharma digital signatures cryptographically guarantee the integrity of every document. And unlike some solutions that bill themselves as “digital” SAFE-BioPharma signatures are based on interoperable identities. They are trusted by government agencies and by other important collaborators outside the organization’s firewall.

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.

The NCI/Bristol-Myers Sqibb/Sanofi study started in 2010. BMS and Sanofi researchers are using SAFE-BioPharma digital identity credentials and NCI researchers are using digital identity credentials issued by the federal government. Because of their interoperability, all were able to access, sign and exchange documents using cloud computing.

As one sign of efficiency, NCI informally calculated that each digital signature used in the study saved about 2.2 hours over conventional “wet” signatures.

As the study moves to production, we are enhancing the signing application to fit into NCI processes with even greater efficiency.

I’m confident that lessons from this study will have a long range impact on the clinical trial process. Readers who are interested should download the white paper documenting its development and success (

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.
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