SuperLineage^TM is a standardized format and approach, developed by Droice, that can be supplied along with real-world patient data (RWD) in data standards/data models (e.g., common data models or CDMs) to make RWD reliable for regulatory use.

The healthcare industry has not yet overcome the quality and reliability issues of RWD, severely limiting their use in critical applications. Data transformations from source RWD into CDM and analysis results can result in information loss that must be considered when drawing conclusions from RWE studies, as mentioned in the current FDA guidance documents.

For RWD to be reliable for regulatory use, traceability to source data is required to validate whether data accuracy and completeness are sufficient for the intended application. FDA guidance documents describe accuracy, completeness, and traceability as critical attributes of reliable RWD for regulatory submissions.

SuperLineage comprehensively captures information from both the structure and content of the source RWD, preserving element-level lineage, and makes the CDM data reliable for regulatory use.