Certara, the global biosimulation technology-enabled drug development company, announced the introduction of Phoenix Technology Services. These services, led and implemented by Certara’s professional team of biosimulation (modeling and simulation) experts, include customized and ready-to-use solutions that span the breadth of the Phoenix platform.
Phoenix is the industry’s premier software platform for managing, analyzing and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data. Certara has developed these services to leverage the enormous power of Phoenix by systematizing the ‘best practices’ of its more than 6,000 users and making those practices available to all biopharm organizations.
“Biosimulation has had a profoundly positive impact on drug development and is now expected by global regulators. In fact, 95 percent of the 45 new drugs approved by the US Food and Drug Administration (FDA) in 2015 used the technology to inform label claims. Additionally, the industry trend is toward moving R&D decision-making around drug viability earlier in the development process and using biosimulation to inform that process,” said Certara chief executive officer Edmundo Muniz, MD, PhD. “The Phoenix Technology Services portfolio is being introduced to help our clients leverage Phoenix software to take advantage of these trends in both pre-clinical and clinical development.”
Certara is introducing several new services within the Phoenix Technology Services portfolio:
Phoenix Workflow Template Services have been developed to optimize R&D productivity, analysis time, standardize calculations and output, minimize quality control checks, and achieve regulatory compliance. Although any Phoenix workflow can be saved as a template, creating reusable templates for handling large amounts of data sets across different studies with varying numbers of treatments, analytes, matrices, and doses requires expertise and significant development time. Templates for discovery PK, pre-clinical and clinical PK are now available ready to use or can be customized for specific workflows and parameters. These pre-packaged templates include serial and sparse sampling for TK studies and CDISC SEND, which will provide sponsors and CROs with more effective knowledge transfer between databases and enable robust protocols for regulatory submission.
Phoenix Plugin Services, such as PopPK data preparer, First-in-Human allometric scaling, CDISC data preparer, and dosing/treatment randomization builder, streamline data flow by providing access to data required for analysis and regulatory submission. These plug-ins integrate Phoenix with both upstream and downstream systems such as LIMS, study protocol, compound management, dosing/treatment, randomization, and CDISC submission.
PKS Repository Services support client installations on Phoenix Knowledgebase Server (PKS) and PKS Online products, which provide a 21 CFR Part 11 compliant repository with full audit trail and version control for the storage of Phoenix biosimulation data. These service solutions cover implementation, migration, integration, and validation support which optimizes regulatory readiness.
Validation Services for Phoenix WinNonlin, NLME, and PKS leverage Certara’s team of in-house validation experts for IQ and OQ documentation, thus eliminating the burden on a client’s internal project team to meet regulatory compliance requirements for computer system validation.