The great thing about CDISC is not only the combination of the high level of standardization applied to the study data (SDTM) and analyses data (ADaM), the real strength lays in the underlying technical documents to comply with and facilitate regulatory review. Firstly, we optimize the data by easily looping through the circle of primary manual data review, development programming including program log review, and the FDA-required dataset validation. We even have a complete setup to apply the rules already during programming. When the draft datasets are optimized, we perform the delicate task of creating the technical documents, including define.xml, the annotated CRF, and reviewer’s guides. Ultimately, we perform a full validation with the data in context of define.xml and resolve the final issues or explain why they cannot be solved. This is done with a broad scope, starting from data collection on the CRF to clear explanations to speed up regulatory data review and addressing FDA-compliancy.
We are highly experienced in CDISC programming and we can create all required technical and supportive documentation for you to deliver concise and FDA data submission compliant CDISC SDTM and ADaM packages.
Do you need CDISC experts? Simply contact us!
