Many aspects of the clinical lifecycle are improved by proper management of metadata inside a central metadata repository.
Improving data quality is the key driver for implementing internal standards and a metadata management system.
- Define all your data up front
- Ensure consistency across studies
- Standardize mappings between different parts of the clinical lifecycle
- Drive study designs from standards
- Perform compliance checks to ensure adherance to standards.
A centralized metadata repository supporting the latest industry standards such as CDISC SDTM, ADaM and Define-XML ensures you can meet the requirements of regulators such as the FDA, PMDA and EMA.
Removing information silos
Silos reduce visibility of metadata, making it hard to standardize and reuse. Bringing all your assets into a centralized repository ensures information is easily accessible and in a consistent format, facilitating standardization and reuse and enabling you to make the right decisions.
Managing metadata in a centralized system allows consistent change control and governance processes.
Single source of truth
A centralized metadata repository gives a single location to find your metadata assets. No more trying to remember where something is kept, or whether there's a newer version somewhere else.
Reuse of metadata
Study setup time can be dramatically reduced by pulling from standards. This leads to greater process efficiencies as the content has been already tested and validated, leading to less likelihood of mistakes and consistent mapping to downstream systems.