Streamline Data Management for PK Scientists
The PK scientist’s data pipeline involves diverse raw data types like SAS, R, and other formats from various partners, especially in complex trials with large data volumes. Properly managing data compliance is crucial, tailoring compliance for exploratory studies and ensuring full compliance for clinical studies under FDA’s regulation Title 21 CFR Part 11.
Our cloud application provides complete functionality for PK scientists to manage the data lifecycle for either non-GxP studies, where eSignature is not required, or GxP studies, where eSignatures are necessary.
Integral offers a validated data and model repository with an intuitive user interface for collecting, managing, and storing multiple types of data sets for analysis. Integral allows sponsors to easily and securely share and report internal data with CROs or other partners. This means significant improvement to clinical pharmacology and clinical operations workflows with data that is traceable, reproducible, and secure.
What are the benefits of Integral?
- Security — Certara validates every release of the platform
- Data — works with all analytical software but tightly coupled with Phoenix
- Compliance – uniquely delivered by the customer for each study
- Cost Savings – by using the same platform for all studies, customers can retire costly legacy solutions.
通过监管机构的稽查
- Prepare your organization for audits — The 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. 单一登录、身份验证和电子签名可以与客户端身份验证系统联合使用。
- Enhanced user experience — We have partnered with Okta for single sign-on, authentication, and electronic signatures that can be federated with client authentication systems.
提高运营效率
- Integral provides access to the application through a web UI, a desktop UI, or through adaptors/plugins to other Certara software.
- Clinical data is organized, searchable, and manageable, providing reproducibility of work and business continuity.
- Easily find data using categorizations based on clinical study, project, individual experiments, data, or library.
- 使用基于临床研究、项目、单个实验、数据或库的分类轻松查找数据
- 将文件和文件夹指定为收藏夹，以方便直接访问
Optimize the management of your Pharmacokinetic data sets
Efficiently organize and access all your data and associated models in Certara Integral to enable research teams to collaborate better and to make important development decisions earlier. Key features of Integral are:
- Upload historical clinical data to the repository
- Visibility and control over your analyses of a study
- One-click synchronization of data from workstation to repository
- High-powered elastic search capability
- Study traceability and comparisons
- Automated tracking of data analyses dependencies
- Tracking of individual file versions and user-specified collections of files, versions, and content
- Reconstruct an analysis from a snapshot in time
- Configurable internal security roles
Tightly integrated with Phoenix for seamless workflows
Integral is the perfect complement to the industry leading PK/PD software Phoenix, enabling bio statisticians, PK scientists, and clinical pharmacologists to significantly streamline the workflow in research projects. With our new Phoenix Hosted offering, which enables working with Phoenix in the cloud, PK research workflows become more seamless than ever before – for better performance, better collaboration, and less effort in maintaining the IT infrastructure.
Integral is ISO 27001 certified by BSI
保护您宝贵的信息资产至关重要。因此，我们对 Certara 的信息安全管理系统 (ISMS) 获得 ISO 27001 认证感到自豪。我们的认证证明，我们致力于保护您的数据，确保数据的保密性、完整性和可用性。
有了 ISO 27001，您就可以放心，因为我们已经实施了强有力的安全控制，进行了严格的风险评估，并不断努力改进。
