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Integral® Data Repository

Repository in support of your PK Scientists

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Simplifying data management and enhancing collaboration for PK scientists

Pharmacometric teams face many data-related productivity challenges. For example, version control problems and data silos may create weeks of quality control and aggregation work before scientists can begin modeling and analysis. Those lucky enough to have a single source of data often still struggle to find, access, and work with the data in their analysis and modeling tools. Once found, they may need to manually upload delimited files and then repeat the process all over again each time the data is updated. Too often, these manual processes lead to costly errors and delays.

Certara Integral® is a purpose-built data and model repository for the pharma and life sciences industry. Integral provides complete functionality for PK scientists to manage the data lifecycles for both GxP and non-GxP studies and helps facilitate their analysis work and drive efficiency.

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Optimize the management of your pharmacokinetic data sets

Certara Integral transforms clinical data management, providing teams with efficient tools to organize, access, and analyze data for improved decision-making. Its intuitive interface and advanced features promote traceability, reproducibility, and security across the entire data lifecycle.

Manage non-GxP and GxP studies with ease
Enable study traceability with automated tracking of dependencies
Ensure secure integration with other data systems via REST API

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Why Certara

Certara empowers PK scientists and clinical teams with innovative, validated solutions that streamline workflows and enhance data security.

  • Certara’s PK/PD software is trusted and widely used by industry leaders and regulatory authorities alike.
  • We have a 30-year history of innovation in pharmacokinetic (PK) analysis and modeling software.
  • Our team combines deep expertise in pre-cinical and clinical research, guided by renowned experts in the field.

"A cloud based solution takes away the need for IT infrastructure around a company. No need for IT support, validation support, computer systems compliance support - a lot of those things are taken over by the company which then can alleviate us to focus more on the science.”

Charles River Laboratories

Jocelyn Webb
Charles River Laboratories

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Leveraging a Compliant Data Repository to Significantly Improve Biostatistics Workflow

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With Certara Integral, your data is secure

Certara holds ISO 27001 certification for Certara’s Information Security Management System (ISMS). We have implemented robust security controls, undergone rigorous risk assessments, and continuously strive for improvement. Certara Integral ensures full compliance with global data protection standards, offering peace of mind for sensitive analysis.

Learn more in our Trust Center

Schedule a demo

Experience the power of Certara Integral Data Repository. Schedule a demo today to see how it can transform your clinical data workflows.

Streamline data management with a validated platform
Ensure compliance with FDA regulations
Enhance collaboration and decision-making across teams


Integral Data Repository frequently asked questions

What types of data can Certara Integral manage?

Certara Integral supports diverse data types, including SAS, R, and other formats, ensuring compatibility with your existing workflows.

Can Integral handle version control for analyses and datasets?

Yes, Integral offers robust version control, allowing users to track changes, compare file versions, and roll back to previous Save Points as needed.

Can Certara Integral integrate with other software?

Yes, Certara’s Integral integrates seamlessly with other software through its REST API, centralizing data from sources like SharePoint, Box, and sFTP systems, while enabling one-click import into Phoenix to streamline workflows for biostatisticians, PK scientists, and clinical pharmacologists.

How does Integral facilitate collaboration between teams?

Integral enables secure data sharing and collaboration through access controls, web-based file transfers, and compatibility with various operating systems and analytical software.

What size company is a good target for Integral?

Integral customers range from virtual biotech companies without any real IT infrastructure to top-tier pharma looking to outsource the burden of implementing, validating, and managing a data repository. Any company doing regulated drug development has a need for a solution like Certara Integral.

If a company has another clinical data repository (CDR) that all functions are using how does Integral fit with their needs and their environment?

Certara publishes a REST API to Integral allowing connections to other data sources as inputs or as a place to transfer data to, which allows Integral to complement other clinical data repositories. Most CDRs act as a simple store for clinical data, which does not provide track the sort of data analysis performed by Clinical Pharmacologists and Pharmacometricians. Integral has the additional functionality of automatically storing CDISC domains in relational tables allowing these data to be mined, which most CDRs do not accommodate.

Does Integral connect to Watson and Pristima?

Certara publishes the API to Integral, making it possible to build connectors to other data sources. Phoenix comes out of the box with a free plugin to Watson LIMS that facilitates the transfer from Watson to Integral.

What does Certara validate with each release of Integral?

Certara validates all functionality of the repository itself, as well as all of the functionality of the Integral client applications and plugins. This leaves only the connection to the repository from the customer’s environment (from Phoenix WinNonlin or other) to the customer to complete.

Certara produces many documents to help customers validate. We deliver release notes, “What’s New” materials, as well as a full suite of validation documents such as a Risk Assessment Report and Validation and Deployment Plans. Some of these files are available to be delivered to customers, while others can only be inspected through our ZenQMS quality system.

Customer validation teams should contact Support or their CSM for more details.

Does Integral import and store bioanalytical data?

The storage of bioanalytical data will be one of the primary use cases for Integral. Storage of BA data in Integral allows for complete traceability of all derived data resulting from the analysis of bioanalytical data as performed by DMPK, Clinical Pharmacology, and Pharmacometric scientists.