By Clinical Informatics News Staff

March 3, 2016 | DrugDev and Exostar yesterday announced they will combine Exostar’s identity credential with the DrugDev Golden Number, linking their unique global identifiers for clinical operations personnel and facilities.

Exostar offers SAM, a turnkey, cloud-based identity and access management solution that delivers single sign-on application access with strong, multi-factor authentication. DrugDev provides a universal identifier called the DrugDev Golden Number for tracking persons and facilities across multiple data sources. Bringing the two identifiers together will allow joint customers to combine secure, seamless access to site-facing applications with historical data to provide a single source of the truth for person and site activity.

Pharmaceutical companies and CROs have access to a variety of data sources containing information about investigators and sites, but these data often are spread across multiple internal and external systems, each with its own set of identifiers and access requirements. The lack of a common identifier and identity credential generates inefficiencies and security risks throughout the clinical trial process such as sub-optimal site selection, need for repeat collection of administrative data and potential for data compromise, and inability to track payments across studies for investigators and facilities, the companies said in the announcement.

DrugDev has developed, and continued to refine, a universal identifier for persons and facilities called the DrugDev Golden Number to solve the issue of integration across data sources. Using a combination of automated algorithms and manual curation, the DrugDev canonicalization process for identity assignment improves over time as the system learns more variations for a single person or facility. Recognizing the power of the DrugDev Golden Number, collaborations such as the TransCelerate Shared Investigator Platform (SIP) and Investigator Registry (IR) and the Investigator Databank have partnered with DrugDev to support data sharing and mastering.

In parallel, the industry is also moving toward enabling secure single sign-on across site-facing applications such as the TransCelerate SIP, electronic data capture systems, training, and other applications to decrease investigator burden and enhance protection of intellectual property and sensitive systems and data. By linking the power and trust of Exostar’s SAFE-BioPharma compliant federated identity credential and the DrugDev Golden Number, the industry will now be able to securely combine data from all site-facing applications using single sign-on with non-site facing data sources.

“Exostar improves investigator productivity and information security by leveraging a single credential to authenticate identities for application access and digital signatures,” said Tom Johnson, Exostar’s Senior Director of Life Science Solutions, in a press release. “By tying that credential to the DrugDev Golden Number, Exostar and DrugDev are bridging the gap between access and data. Together, we’ll ultimately provide a secure, complete line-of-sight that the industry desperately needs, from historical information and study start-up through study completion, and integration back into company historical data.”

In the same statement, Elisa Cascade, DrugDev President, Data Solutions, explained, “We’re excited to be working with Exostar to change the way the industry masters data related to persons and facilities. DrugDev’s collaboration with Exostar reflects our commitment to driving standards and facilitating industry-wide collaboration to reduce burden and realize cost efficiencies for all key stakeholders.”