These standards find widespread application during the clinical data analysis, reporting, and regulatory submission processes. For example, the Study Data Tabulation Model (SDTM) is the submission data standard that raw study data are mapped into and compiled in order to be submitted. It is recommended that SDTM data be used as the source for these datasets, as ADaM is a companion standard meant to be used in conjunction with analysis data. The CDISC standard for data definition files is called Define-XML, and if you do this, you can easily record any data processing you do using it. We are experts in mapping to CDISC Standards and offer a variety of CDISC Services here at NovusScientia

NovusScientia has a wealth of experience in assisting its clients in meeting the requirements of the CDISC standard. We have worked on both large and small projects that were special to CDISC. Some of these projects involved merely consulting, while others required the mapping of many studies to CDISC criteria.

OUR Services Include the Following

• the development of individualised CDISC solutions
• Developing new databases that are compliant with CDISC CDASH/SDTM
• CDISC SDTM domains created from a variety of customer-defined data standards
• Mapping of studies from legacy to CDISC standards in order to meet ISS/ISE reporting requirements and submit them to the FDA
• Compatibility with all available versions of the SDTM/ADaM standards and the define.xml implementation guide
• The process of converting datasets from CDISC ODM XML to SAS® and vice versa
• In preparation for a regulatory submission to the FDA, the define.xml package was created, which included reviewers guidelines, annotated CRFs, and SAS V5 XPT files.
• In order to facilitate TFL output and ensure data traceability from CRF to CSR, ADaM domains have been created.
• Programming statistics by using datasets obtained from ADaM as inputs to the SAS® report code