Certara® the global leader in model-informed drug development,
regulatory science, real-world evidence and market access services,
today 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.
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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. (Graphic: Business Wire)
“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®.”
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.
“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.”
Certara will be hosting a one-hour webinar entitled “Next-generation
Data Repository for Clinical Pharmacology & Pharmacometrics” to
introduce Certara Integral™ and cover its most important attributes on
May 29 at 11 am EDT. Interested parties can register for the
complimentary webinar here.
About Certara
Certara enables superior drug development and patient care
decision-making through model-informed drug development, regulatory
science, real-world evidence solutions and knowledge integration. As a
result, it optimizes R&D productivity, commercial value and patient
outcomes. Its clients include hundreds of global biopharmaceutical
companies, leading academic institutions, and key regulatory agencies
across 60 countries. For more information, visit www.certara.com.
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