It Is a Multi-Functional, Cloud-Based, 21 Cfr Part 11 Compliant Platform for Clinical Pharmacology, Pharmacometrics and Clinical Operations Professionals
Certara the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, announced the introduction of Certara Integral, its next-generation data repository for collecting, managing, and storing multiple types of data sets for analysis, sharing and reporting of clinical pharmacology, pharmacometrics and other relevant clinical data.
“Our clients were becoming overwhelmed with the number of disparate tools and amount of data they had to manage, and asked us to create a system that would enable them to quickly organize, categorize, retrieve, visualize and analyze their PK data”
“As the amount and accessibility of clinical and regulatory data has exploded, so has the need for systems and infrastructure that can streamline complex decision-making,” said Michael Eckstut, senior vice president and head of Certara’s pharmacometrics software group. “In developing Integral, we combined the knowledge gained by our 175 drug development, clinical pharmacology and pharmacometrics scientific experts, with the software development skills of our pharmacometrics and scientific informatics teams to create a unique multi-functional product. We believe that Integral will follow the adoption curve established by Certara’s other industry-leading technologies, such as Phoenix®, D360, and Simcyp®.”
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Certara Integral™ combines the attributes of a software-agnostic data warehouse with a workflow-driven tracking and retrieval toolkit housed in a cloud-based, 21 CFR Part 11 compliant infrastructure. Data are highly organized and can be categorized by clinical study, project, and individual experiments, enabling users to ask ‘what if’ questions at all levels. Integral allows users, and their associated partners, to interact with multiple sources and types of data via client apps, plug-ins and APIs. Certara Integral™ is agnostic with respect to the type of analytical tool or data used by the customer.
Recognizing the tremendous scientific advances occurring in translational medicine, Certara has added the new concept of linking study files into Integral. Linking allows multiple and cross-study analyses to be anchored by a single file stored in a single location. This allows users to compare multiple research scenarios and apply different queries to guide decision-making, while maintaining an audit trail. To facilitate visualization of results, Certara Integral™ has optimized viewing panes, which are accessible via an Integral web app.
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“Our clients were becoming overwhelmed with the number of disparate tools and amount of data they had to manage, and asked us to create a system that would enable them to quickly organize, categorize, retrieve, visualize and analyze their PK data,” said Kevin Trimm, product manager for Certara’s pharmacometrics software portfolio. “We listened and created a repository that will meet their PK needs today, and expand into other clinical and non-clinical data storage and analysis areas in future iterations. For example, Certara Integral™ will connect all PK CDISC domains out of the box, and will be expanded to cover all SDTM and SEND domains in the future.”
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