Identity Trust is a Must in Clinical Development Collaborations

May 24, 2016
Mollie Shields-Uehling

Mollie Shields-Uehling is president and CEO of SAFE-BioPharma Association

Identity trust platforms assure clinical investigators that their credentials are legitimate by allowing use of a single identity that can be recognized across multiple entities. These platforms support collaboration by allowing drug development participants to access data, sign and exchange documents.

Identity trust is foundational to clinical development platforms such as TransCelerate's Shared Investigator Platform (SIP) and Merck's EngageZone. It lets all of their respective participants collaborate efficiently and securely by assuring that the identity accessing a portal and the valuable and proprietary information it contains does not belong to someone else. And identity trust relieves the burden on clinical investigators by allowing use of a single identity that can be recognized across business, government and academic entities.   SIP, EngageZone, and other platforms support collaboration by allowing researchers, clinicians, patient groups, executives, and others participating in drug development to access data and sign and exchange documents. Given the potential of thousands of participants from around the globe, identity trust is a must.   The Shared Investigator Platform became operational earlier this year, and EngageZone has 60,000+ participants. Each requires those accessing the platforms to use identity credentials that are complaint with the global SAFE-BioPharma digital identity management and signature standard. Each requires those accessing the platforms to use identity credentials that are complaint with the global SAFE-BioPharma digital identity management and signature standard.    SAFE-BioPharma is invisible and operates in the background; not unlike lubricant that keep cars performing their best. Like our cars, bodies, and anything else we rely on, it's worth having some knowledge of what's going on inside.   SAFE-BioPharma was created by pharma IT executives as way to assure identity trust over the Internet. They chose an approach requiring identity credentials to be issued following a process that proves the individual's legal identity through the presentation and review of documentation and/or biometric evidence. The process is aligned with national and international laws, regulations and standards. Because of this alignment, identity credentials compliant with the SAFE-BioPharma standard can be trusted by other entities, including US Government agencies, pharmaceutical and healthcare companies, and companies in other industries.   One credential for multiple trials. As every participant in the Shared Investigator Platform will soon realize, the SAFE-BioPharma identity credential can be used for most other trials from the same and other sponsors. No more multiple user names and passwords! The SAFE-BioPharma compliant credential will be your single identity. Think of it as a personal passport to the Internet: one trusted credential identifying you for all trials.   Signing and protecting electronic documents. Individuals with a specific type of SAFE-BioPharma identity credential are able to apply digital signatures to electronic documents. It is the single strongest form of electronic signature in existence. Based on cryptography, the signatures are legally binding and cannot be denied by the signatory. They provide the strongest proof of the person who applied the signature, and they protect the document by revealing when a change to the signed document is made.   As researchers, clinicians and others participating in collaborative clinical development platforms learn that the identity credentials they've acquired are SAFE-BioPharma compliant they'll be able to operate without the hassle of managing too many cyber identities. It's making the entire development process more efficient. And it's all based on identity trust. It's a must!   Mollie Shields-Uehling is the President and CEO of SAFE-BioPharma Association

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