For submissions of New Drug Applications (NDAs) to the Food and Drug Administration (FDA), it is requested to submit all clinical study data according to the CDISC standards.
Before storing the submitted CDISC clinical data and metadata, the FDA runs a set of CDISC compliance checks. Non-compliant study data may not be loaded into the repository.
Business & Decision Life Sciences has created an enhanced list of these CDISC compliance checks integrated into a flexible compliance check application.
The CDISC compliance check application is a system that contains a metadata definition of the SDTM and ADaM standards and the available CDISC controlled terminology.
The CDISC compliance check application runs an enhanced list of checks to verify compliance of both data and metadata against the current CDISC standards such as SDTM, ADaM, controlled terminology (CT) and define.xml.
A company specific standard and associated checks can be uploaded in the application.
The CDISC compliance issues are logged in an exception table. A flexible check report generator creates a set of reports for further processing either in paper, electronic or .xml format.
Based on this compliance check application, Business & Decision Life Sciences has developed a set of services. These to ensure the sponsor’s CDISC datasets and metadata are of excellent quality and fully compliant with the current CDISC requirements.
These services include:
Additionally, Business & Decision Life Sciences can: