Background
Our clients are mid-to-large size healthcare companies based in Europe, willing to fully embrace digital technologies.
Challenge
Our client wanted to mitigate the time and effort required to map the data from their EDC system to the CDISC-SDTM data format.
Approach
– Analysis and questioning of current methodologies,
– Improvement of the standardization and reuse of code from past clinical trials,
– Selection of a Clinical MetaData Repository (CMDR) system to streamline data flows and automate the majority of manual tasks,
– Use of Natural Language Processing (NLP) techniques on metadata to facilitate the data mapping procedure.
Key results
1. Acceleration of the mapping between EDC data and the SDTM data format, ready for submission to regulatory authorities.
2. Simplification of maintenance and updates in the event of protocol amendments.
3. Enhancement of reporting reliability for pharmacovigilance.
Benefits
By promoting process standardization, selecting and integrating new software platforms, and leveraging advanced A.I technologies; Keyrus can help you shorten and harmonise your clinical data management workflows.
