Bringing together all your pharmacokinetic (PK) data from multiple, disparate storage methods makes it challenging to manage and organize that data; remain 21 CFR Part 11 compliant for regulatory submissions; and search, visualize, and analyze the data. This is particularly true with the large volumes of PK data that accompany today’s more complex trials. Data quickly becomes out of date, and version control is difficult.
Enter Certara Integral, a next-generation cloud-based, software as a service (SaaS), validated data and model repository with an intuitive user interface for collecting, managing, and storing multiple types of data sets for analysis, sharing, and reporting of clinical pharmacology, pharmacometric, and all other clinical data.
This regulatory compliant repository significantly improves the clinical pharmacology workflow, providing PK data that is traceable, reproducible, and secure as well as enabling better-informed drug development decisions.
- Prepare your organization for audits. The data, data generation, and data storage are all traceable, reliable, accessible, reproducible, and secure
- Facilitate 21 CFR Part 11 compliance. Certara Integral provides a compliant chain of custody for electronic records. Single sign-on, authentication, and electronic signatures can be federated with client authentication systems.
- Be confident in the security of your data. Integral includes a logical separation between each client’s data in the Oracle database.
Efficiently organize and access all your data and associated models in Certara Integral to make important development decisions earlier. You get notified when changes to data affect
- Access historical clinical pharmacology data
- Transform CDISC domains to relational database tables
- Gain visibility into progress of your analyses
- Synchronize data from workstation to repository
- Use high-powered elastic search
- Track individual file versions and user-specified
collections of files, versions, and content
- Compare analyses versions
Integral integrates with your IT infrastructure from Day 1, via client applications, plug-ins, or APIs and is data- and analytical-tool agnostic.
An Oracle database foundation with variable Amazon Web Services (AWS) infrastructure provides load balancing and the ability to scale quickly.
- Organize, search, and manage your PK data
- Easily find data using categorizations based on clinical study, project, individual experiments, data, or library
- Designate files and folders as favorites for easy, direct access