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.
규제 당국 점검 통과
- 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. 단일 인증, 사용자 인증 및 전자 서명은 고객 인증 시스템과 연계될 수 있습니다.
- Enhanced user experience — We have partnered with Okta for single sign-on, authentication, and electronic signatures that can be federated with client authentication systems.
운영 효율성 증대
- 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.
- 임상시험, 프로젝트, 개별 실험, 데이터 또는 라이브러리를 기반으로 한 분류를 통해 손쉽게 데이터 찾을 수 있음.
- 직접 쉽게 액세스할 수 있도록 파일 및 폴더를 즐겨찾기로 지정.
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
Protecting your valuable information assets is paramount. That’s why we are proud that Certara’s information security management systems (ISMS) holds an ISO 27001 certification. Our certification proves our commitment to safeguarding your data, ensuring its confidentiality, integrity, and availability.
With ISO 27001, you can have peace of mind knowing that we have implemented robust security controls, undergone rigorous risk assessments, and continuously strive for improvement.
