Facilitate data mapping to SDTM by leveraging standardisation and A.I.

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

- Analysed and challenged current methodologies, - Improved standardisation and reuse of codes from past clinical trials, - Selected a Clinical MetaData Repository system (CMDR) to streamline the data flows and automate most of the manual tasks - Leveraged natural language processing techniques (NLP) on metadata to ease the data mapping procedure

Key results

Accelerate the mapping between the EDC data and the SDTM data format ready for submission to authorities.

Ease maintenance and update in case of amendments.

Make reporting for pharmacovigilance more robust.

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.

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