SDTM submissions are a regulatory requirement for submitting clincal trial data to the authorities for approval. Each pharma company has their own take on how they achieve the goal of transforming their clinical data to the prescribed SDTM format.

 

Simply put, the 'Study Data Tabulation Model' (SDTM) developed by the 'Clinical Data Interchange Standards Consortium' (CDISC), is a prescribed framework for data to be submitted as data sets (domains) with specific variables and rules for each.​

 

The challenges in SDTM development arise mainly from the fact that most data is collected in a non-CDISC format and then mapped to the CDISC structure, this could either be due to insufficient understanding of the standards, collection of unnecessary data points, system limitations, therapeutic area standards etc.

 

Although more and more setups strive to 'get it right' from the very beginning by conforming the collected data to the CDISC structure, it is not always possible.

 

At Citus Consulting, our SDTM consultant will work with you to solve your mapping problems, provide you 'clean', 'well documented', 'indented' codes/programs and supporting documents such as the cSDRG, aCRF and define.xml, to achieve your final objectives of a smooth SDTM submission.

 

We strive to provide you with quality SDTM data with fast turn around times, to give you the benefit of having the extra time for data review and cleaning before submissions to address any possible data issues.