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International Clinical Trials

Cyber Security

A single, secure and interoperable digital identity that ensures trusted authentication and protects electronic documents is arguably the way ahead for sponsors, CROs, clinicians and other trial stakeholders. SAFE-BioPharma’s digital identity and digital signature standard, in particular, is being used for many applications

Global collaboration has caused us to vastly expand our information systems into the great unknown. With that expansion, we invite participation from people outside our historic circles of trust; people from diverse organisations and geographies. This is an issue for anyone developing or managing clinical trials. How do we protect information assets while providing access to them? How should we scale up while maintaining control? How can we to reduce costs and improve clinical trial productivity? Each is a situation best not left to chance.

These issues were anticipated and addressed by a pioneering group of biopharmaceutical IT executives almost 10 years ago. Recognising the need for a scalable way to create a trustworthy cyber-identity, they adapted a model used in other industries and created a standardised approach for the unique needs of the biopharma and healthcare sectors. The result is the SAFE-BioPharma digital identity and digital signature standard. From the outset, the standard has benefited from engagement by the Food and Drug Administration and the European Medicines Agency.

Identity Credential

The standard requires each user to undergo a process linking the digital-identity to the user’s proven identity, and the user to agree to abide by certain rules and procedures. It is generally completed online and results in issuance of a digital identity credential – a form of software traditionally installed on a computer and used with a token, but now stored in the cloud and accessed using desktop, tablet or smartphone. The new cloud-located credential is called SAFEBioPharma Mobile.

Once provided with the digital identity credential, the user can authenticate their identity into systems where authorisation has been established. In addition to being uniquely linked to its user, the identity credential is virtually universal. It can take the place of the multiple electronic (and minimally secure) credentials typically used in the trial setting. And because sponsors and CROs can rely on the existing credential, they are able to strip their budgets of those line items related to provisioning and managing less secure electronic identities, including costs associated with user name/password resets.

Trust and Interoperability

The identity credential provides two fundamental services: it informs systems that its user’s identity can be trusted (authentication); and it provides the user with the ability to apply legally-binding and regulatory compliant digital signatures to electronic documents. These two characteristics are fundamental to enabling secure, global, cloud collaboration.

Also key is the interoperability of SAFE-BioPharma identity credentials with those from other systems. Interoperability means that an identity asserted by one system will be trusted by another. SAFE-BioPharma digital identities are interoperable with a growing body of organisations, most notably the US federal government and its agencies, such as the Food and Drug Administration and the National Institutes of Health. The interoperability is not limited to the US government. It exists between companies both within the biopharmaceutical industry and in other industries. This interoperability is based on annually audited, binding agreements around standards of identity trust, and the technologies and technical processes used to convey that trust electronically.

Digital signatures are superior to common electronic signatures in ways that truly free an organisation from paper. The close linkage between credential and proven identity makes a signature created with the credential non-repudiable once the signature has been applied, so it cannot be legally denied. A signature also has the unique advantage of providing protection for the life of the electronic document. It graphically invalidates if any change is made to the document, regardless of when it was signed. Digitally signed documents also automate the audit process, saving more than just time.

Pioneering Cloud Collaboration

Over the past few years, a study involving the US government and industry cancer researchers has shown how interoperable digital identities, digital signatures and cloud computing combine to accelerate initiation of a clinical trial while reducing costs. Cancer researchers at the National Cancer Institute (NCI) and their counterparts at Sanofi and Bristol-Myers Squibb participated in a pilot study in which trial start-up documents were placed in the cloud and securely accessed using interoperable digital identities. Like many organisations, NCI historically relied on paper-based processes where letters, contracts and other documentation were sent by courier, fax, and so on – costly processes fraught with delays.

In the study, the public and private sector researchers quickly retrieved the documents from the cloud, before reviewing, signing and exchanging them – reducing NCI’s costs and significantly accelerating what was otherwise a much slower process.

Hospital Patient Data

In another study, a global biopharma company examined the use of SAFE-BioPharma digital identities on iPad tablets to securely collect and transmit patient data gathered from electronic health records while in hospital. The situation was devised to determine if the technology was viable in an internet blackout zone, or where cell phones and other devices were banned because of patient confidentiality concerns.

What the company learned is that patient data can be collected and transferred with startling efficiency and accuracy. Using their digital identity credentials, the physicians authenticated their identity, which gave them access to the electronic health records. They then collected the patient data, placed it in forms and applied their digital signatures.

Each iPad was provisioned with a digital credential identifying the iPad’s user, and contained a specialised mobile application to gather and record the patient information. The data was collected in internet blackout zones and temporarily stored in the iPad for later, secure internet transmission to a central clinical trial system. When patients required prescriptions, the investigator applied a digital signature to the ePrescription and sent it to a central clinical trial system.

ePrescriptions for Controlled Substances

In the US, auditing and dispensing regulations require prescriptions for controlled substances to have multiple printed copies. The Drug Enforcement Agency has stated that SAFE-BioPharma digital signatures are appropriate to sign ePrescriptions for controlled substances, thus allowing all forms to be filed electronically. The cloudbased SAFE-BioPharma Mobile identity credential permits authorised medical personnel to login through a mobile device and apply digital signatures to ePrescriptions. This capability will soon be in the hands of several hundred thousand US physicians.

Executives and managers who appreciate the benefits of digital identities – identity trust, managed access to a variety of systems, the convenience of a single cyber-identity, the ability to apply legally-binding digital signatures to protect documents, uncomplicated audits, full portability, etc – will understand the many ways they can be put to use. The applications being explored by companies for use of SAFE-BioPharma identities include:

● Authentication into portals and applications: facilitating access to trial literature, protocols, forms, and so on

● eSampling: paper forms are eliminated and a fully electronic audit trail automatically established. One company has experimented with an eSampling model in which the doctor applies a digital signature to an ePrescription for a sample and transmits it to pharmacy to be filled

● eTMFs: facilitating electronic management, viewing and searches for trial master file content without the need to store content as pdfs

● Adverse event reporting

● Regulatory document management systems

However, whatever the application, digital identities give sponsors, CROs, clinicians and others involved in the trial process the distinct advantage of secure and trusted authentication and of electronic documents that digital signatures permanently protect against change. Use of digital credentials and signatures frees organisations to capture all the benefits of cloud collaboration without the concern about whether or not collaborators are who they claim to be. It also frees every organisation from the insidious and redundant costs of issuing and maintaining less secure and less effective forms of electronic identity. It is time for our industry to embrace the idea of a single, secure and interoperable digital identity for each participant in the development process.


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Mollie Shields-Uehling is President and CEO of SAFE-BioPharma Association, where she directs the business and strategic activities associated with its digital identity and digital signature standard. Mollie has more than 20 years’ international trade and biopharmaceutical industry experience. She headed an international public affairs consultancy and served in various leadership positions with Bristol- Myers Squibb, Wyeth, the International AIDS Vaccine Initiative, the White House Offi ce of the US Trade Representative and the US Foreign Commercial Service. She has been recognised by PharmaVOICE magazine as one of the pharma industry’s most infl uential leaders.
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