Anzo lets you harmonize clinical data over time and manage the metadata that describes your trial submissions
Anzo includes flexible metadata management capabilities that can be easily extended and customized to track metadata specific to your clinical trials. Anzo can maintain metadata models for different versions of the CDISC standards while also tracking metadata attributes and elements that are specific to your organization standards or to specific drugs or trials. Finally, Anzo makes clinical metadata active so that you can directly use either CDISC or internal standards to drive clinical data analysis, harmonization, or preparation for regulatory submission.
- Key Benefits
- Use Cases
1. Support cross-study analysis by harmonizing clinical metadata from different trials
2. Automate adoption of new versions of the CDISC standards
3. Provide self-service access to clinical metadata via customized views of trial variables, controlled terminologies, and other metadata for clinical data analysts, SAS programmers, and data standards officers
4. Govern changes to clinical metadata with audit trails, change control, and approval work flows
5. Directly apply metadata to help downstream integration, analysis, and reporting on clinical data
● A large pharma organization uses Anzo to track variations in clinical metadata across products and different versions of the CDISC standards.
● A mid size biotech uses Anzo to transform clinical data output from SAS and a variety of CDRs into forms suitable for regulatory submission or self-service analysis.
● Another biotech uses Anzo to easily collect trial site, investigator, personnel, enrollment, and other operational data from dozens of CROs for easy access by clinical analysts and for staging into a CTMS.
● Track the lineage of metadata changes.
● Customize the metadata that you want to track on a company-wide, per-product, or per-study basis.
● Configure approval work flows for key metadata element changes.
● Provide user-friendly clinical metadata access via the web and Excel.