CONFORM™ Metadata Warehouse
A metadata management bundle to encompass and consolidate myriad clinical metadata standards. Designed to improve the quality and flow of data throughout the Clinical Data Lifecycle, reduce redundancies, and increase work efficiency.
The CONFORM™ MDW allows clients to store, efficiently manage and leverage objects of various external clinical applications (e.g., EDC, ETL, TLF, etc.). The MDW includes an API that allows for bi-directional exchange of metadata between the repositories, the applications, and contributors where the sponsor determines it is appropriate. The system supports numerous EDETEK CTMP applications as well as Medidata Rave EDC.
The MDW provides the following capabilities:
- Conceptual, Logical and Physical Modeling
- Comprehensive Metadata Management
- Object Inheritance
- Integration with CDISC SHARE Client-Configurable Clinical Hierarchy
- Version (and Up-Version) Management Across all Metadata Components (Structure, Semantics, Controlled Terminology, Validation, etc.)
- Standards Change Impact Analysis Supporting Risk and Cost Assessments
- Events Management for all Events and Actions Supporting Continuous Process Improvement
- Comprehensive 21 CFR Part 11 Access Control
- Change control management and workflow with included CONFORM™ EMS and CONFORM™ WF components
CONFORM™ Information Hub
Information Hub is an ideal integration solution for modern digital clinical trials that link numerous functional data providers, patient wearable and attached devices, CROs, providers and sponsors that exchange patient, site and study information in real time.
The CONFORM™ Information Hub allows for secure and efficient event-driven information orchestration services with durable retention, traceability and validation of all data transactions it manages. Information Hub is purposely designed to be an Industry information exchange with adapters to numerous popular clinical applications and vendors. Once the vendor, sponsor or organization are registered in the hub as subscriber and/or supplier they join the global clinical information exchange. New customers enjoy re-usability of existing integration adaptors as well as simple and secure communication.
A sample of the Information Hub capabilities:
- Registration of suppliers and subscribers of health care information
- Process and data flow orchestration for all study participants
- Client-defined data exchange event types with bundled CONFORM™ EMS
- A growing list of existing adaptors
- Sponsor – driven security for clinical trials
- IoT interface
- HIPAA firewall for study sponsors
- Systems and human workflow with bundled CONFORM™ WF
- WEB-form information submission for non-digital communications
- Data pulling for legacy systems integration
- Support for high speed large file exchange (digital imaging, videos, etc.)
- Scalable to millions of transactions per hour
- Zero data loss recovery
CONFORM’s newest solution – Repository is a combination of Clinical Data Lake (CDL) with several foundational components of the platform.
Repository is designed to be a globally accessible and compliant store of clinical information, both structured and unstructured. All data and documents stored in the Repository are accessible via CONFORM™ components, custom applications developed by EDETEK or its partners – systems integrators via provided APIs.
Repository can also be used as a shared storage and an archive of study information. Customers can create company or sponsor–specific hierarchies.
Files have built-in version control and all systems and human actions are controlled and monitored by CONFORM™ EMS and CONFORM™ WF systems. CONFORM™ Platform Management maintains roles and user groups that define access and data rights.
Customers can place their repositories in various regions of the world to comply with government regulations.
EDETEK engineers utilize Repository to enhance functionality of CONFORM™. For example, we will be introducing an eTMF application in 2018 which is a custom designed front-end application on top of the Repository.
CONFORM’s most popular solution – Informatics is an upgrade of the Metadata Warehouse bundle that includes all necessary tools to manage CDISC SDTM deliverables and controlled clinical programming environment in Clinical Data Lake.
Designed to manage the entire lifecycle of SDTM mapping, transformation, validation and submission in a compliant workspace. Fully integrated with MDW for SDTM version management at a study level. This bundle also adds a CONFORM™ Data Exchange tool that enables bi-directional data set transfer from and to the Data Lake.
SDTM mapping is performed via a graphical and user – friendly tool that generates transformation code automatically.
CONFORM Informatics - a sample of features
- Clinical Computing Environments hosted in CONFORM™ CDL
- SDTM Map Development Visual source to target designer and mapping tool
- Data Submission Creates Define XML/PDF 2.0
- Validation CDISC, FDA and PMDA rules, EDETEK standard rules, custom logic
- SDTM Conversion Complete SDTM coverage including submission package generation
- Transformation Automated transformation using CONFORM™ MDW study level metadata
- SDTM Annotations Automated production of SDTM annotated CRFs
- Collaboration CONFORM™ WF
- Events Management: CONFORM™ EMS
- Data Exchange: CONFORM™ Data Exchange
- Access Integrated with CONFORM™ Platform Management for data access and functional roles
CONFORM™ Informatics Premium*
A one stop solution for Medical Informatics
We have architected Informatics Premium to be an all encompassing informatics solution for patient data. Informatics Premium is an upgrade to the Informatics bundle that adds creation of ADaM datasets, TLF designer and generator, a high performance Clinical Data Warehouse that stores all Sponsor’s studies.
The Premium bundle handles all patient data CDISC standards, ensures data compliance, aids clinical programmers and biostatisticians, and allows for complex scientific research of all organizational data to help in design of safer and more efficient trials. It is also an ideal repository to serve periodic safety and efficacy regulatory reporting.