Legacy and Ongoing Study Data Conversion: We are specialized in converting legacy data into CDISC SDTM format with the process based approach starting from the CRF annotation to the creation of SDTM compliant datasets.
Consulting includes• CDISC implementation Support • CDISC training • CDISC CDASH & SDTM Compliance • SDTM Mapping Assistance
We help clients to implement CDISC SDTM in their data repositories which help to load the non-standardized data from disparate sources into a single data standard. It also helps in pooling multiple study data into CDISC standard for analysis purposes.
CDISC CDASH Compliance
Synteny has multiple template CRF’s for each of the 16 CDISC CDASH domains available off the shelf, and has the capabilities to create custom CDASH CRF’s for your entire protocol. By using CDISC standards, your company will be able to reuse CRF forms which will gain efficiencies and cut costs by reducing data entry and monitoring errors. The clinical sites will require less training by using standard data collection methodology and the data will require less transformation prior to reporting to the FDA.
Data is exported and delivered to you in submission ready CDISC SDTM domains. Synteny will create a Domain Reference Guide that will show all of the mapping details about how the SDTM dataset is created. Synteny understands all of the CDISC STDM variables that are required and will calculate and deliver all derived variables needed.