Presenters: Pascale Youinou (Business & Decision) and Matthias Feuerstein (ANJU Software)
Sponsor: Irina Sargsyan, Head of Biometrics, Program Director at Business & Decision
Impact of CDISC standards on business optimization
The process of data transformation for data collected during the clinical trials whether via Electronic Data Capture (EDC) or via external systems (e.g. ePRO, etc.) is usually done once the clean and monitored data has been extracted from the EDC system. Many EDC systems are not fully equipped yet to export the data in SDTM format, so the team of programmers maps and transforms the clinical data into industry standards such as CDISC SDTM. This process is time consuming and requires close monitoring of timelines.
But what does it mean to be able to extract the data in SDTM format from EDC system?
In our collaboration with Anju Life Sciences Software, we could configure SDTM exports within TrialMaster EDC solution as soon as the data collection model is defined and eCRF is set-up. Once data is available, the SDTM exports can be run immediately.
In our presentation we will go over the case study to demonstrate all pros and cons of the process as well as lessons learnt.