The Digital CRO

Intralinks is a member of the SAFE-BioPharma vendor partner community, and Intralinks users are able to use the SAFE-BioPharma digital identity for signing documents.


23 September 2010

This is the next in a series of guest blog posts by Intralinks’ collaborators, partners, and vendors. Mollie Shields-Uehling is president and CEO of the SAFE-BioPharma Association. The SAFE-BioPharma® Digital Identity and Signature Standard was established by the biopharmaceutical industry to speed its transformation to a fully electronic environment. Intralinks is a member of the SAFE-BioPharma vendor partner community, and Intralinks users are able to use the SAFE-BioPharma digital identity for signing documents.

These are the stats I use to get the attention of SAFE-BioPharma member companies and their CROs:

  • 90 percent of clinical trial sites have delayed enrollment 
  • the average monthly out-of-pocket cost for delayed trials is $1.2 million
  • study delays involving niche drugs result in lost sales as much as $800,000 per day
  • study delays involving blockbusters result in lost sales as much as $5.4 million per day

Those are among the reasons GSK includes the following message on correspondence with its CROs:

ARE YOU ABLE TO APPLY DIGITAL SIGNATURES USING A SAFE-BIOPHARMA CREDENTIAL? If so, please DO NOT print the attached document! Reply to this email stating that you use SAFE-BioPharma Digital Signatures, and GSK will return the appropriately prepared amendment to you. If your site is not yet equipped with SAFE-BioPharma signing capability, please proceed to www.SAFE-BioPharma.org

By way of background, SAFE-BioPharma is a non-profit consortium of biopharmaceutical and related companies that developed and manages the SAFE-BioPharma digital identity and signature standard. The purpose of the standard is to transition the industry to a paperless environment. Intralinks is one of the association’s vendor partners.

SAFE-BioPharma is being used by most big pharma companies for applying digital signatures in a variety of applications. Most started in the laboratory by applying digital signatures to electronic laboratory notebooks. Then they used SAFE-BioPharma digital signatures to sign the documents associated with submission made through the FDA’s eSubmissions Gateway. Uses of these signatures have spread to contracts, approvals, and now to the many signatures associated with the many forms required to get clinical trials up and running.

"CROs using SAFE-BioPharma digital signatures have greatly improved the turnaround of getting contracts signed and returned. They like it, and we at GSK love it!" That’s how Kevin Hayward of GSK, characterizes the use of SAFE-BioPharma signatures with its CROs.

Why does the digital signature elicit such as strong response over the more common forms of electronic signature?

SAFE-BioPharma digital signatures offer a greater level of protection than other forms of electronic signature. They provide authentication, non-repudiation and data integrity across every single bit of the information to which the signature is applied. In simple terms this means that if any component of the signed document is ever changed, the signature will be invalidated.

These characteristics are possible because the standard requires that the signatory’s identity is carefully vetted and authenticated before being captured in a digital certificate and made available to apply digital signatures. The standard also requires each digital identity to adhere to rules that guide and regulate its uses.

It’s a win-win. Sponsor and company accelerate contract turnaround time. Investigators, CRAs, and CRCs replace redundant identities and excessive and insecure user-names and passwords with a single, secure and trusted SAFE-BioPharma digital identity that is tightly bound to the individual’s identity and that will enable digital signing of contracts and other documents regardless of signers’ schedule or location.

A digital signature pilot between Bristol-Myers Squibb, Sanofi-Aventis and the National Cancer Institute’s Cancer Therapy Evaluation Program is demonstrating the ease of eliminating reliance on paper-based forms in drug development research and clinical trials.

Participants have been issued digital credentials, a prerequisite for being able to apply digital signatures. The BMS and Sanofi-Aventis digital certificates are part of the SAFE-BioPharma identity trust hub and NCI digital certificates are part of the Federal PKI Architecture (FPKIA) identity trust hub. Both trust hubs are fully interoperable, SAFE-BioPharma is cross-certified with FPKIA and meets the government’s identity vetting requirements. Documents being signed include Letters of Intent, Concept Approval, Protocol Approval, Clinical Trial Agreements and Contracts.

The pilot eliminates any need for wet signatures — and therefore, any need for paper. It improves speed and efficiency. This pilot, the work GSK and others are doing with CROs, and the nascent adoption of SAFE-BioPharma within the CRO community speak to a new era of digital CROs — a time when clinical trials get off to a fast start and paper-based delays are a thing of the past.