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DrugDev and Exostar took a major step today in helping the pharma and CRO industry improve and secure clinical trial master data management as the two companies announced they will combine the power of their unique global identifiers for clinical operations personnel and facilities.
Today, many clinical research companies struggle with the ability to fully utilize their internal clinical trial operations data due to the significant amount of identity credential duplication and missing or incorrect records in the system. In addition to lacking a common identifier and mastered data within a company, clinical researchers also face barriers with integrating internal company data with information from other site-facing applications, public data sources, clinical research partners, and cross-company collaborations. The result is sub-optimal decision making, risk of sensitive information exposure and compliance violations, and need for manual labor to integrate across different data sources.
DrugDev and Exostar are committed to solving these problems through the linking of Exostar’s identity credential with the DrugDev Golden Number. 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.
How it Works
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. In addition, the lack of a single common identifier was a significant barrier to facilitating cross-company collaborations as there was no mechanism for secure data sharing across pharmaceutical company and CRO clinical trial management systems.
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 towards 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. “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.”
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.”
Exostar’s cloud-based solutions help companies in highly-regulated industries mitigate risk and solve identity and access challenges. Nearly 125,000 organizations leverage Exostar to help them collaborate securely, efficiently, and compliantly with their partners and suppliers. By offering connect-once, single sign-on access, Exostar strengthens security, reduces expenditures, and raises productivity so customers can better meet contractual, regulatory, and time-to-market objectives. http://www.exostar.com.
DrugDev is an innovative technology company which provides cloud-based solutions to help sponsors, CROs and investigators do more clinical trials together. DrugDev’s unified platform optimizes site selection and activation, investigator payments and clinical operations efficiency. DrugDev also serves as the trusted third-party host of the revolutionary Investigator Databank collaboration and the TransCelerate Investigator Registry. Learn why 9 of the top 10 sponsors and 4 of the top 5 CROs trust on DrugDev technology to do more trials at drugdev.com.