ClinAsia Labs in the process of conversion of clinical trials data to CDISC format makes data ready for regulatory submission. ClinAsia Labs specializes in the conversion of existing raw clinical data to the CDISC formats to ensure they meet the compliance of the regulatory Authorities. The following are the services provided by ClinAsia Labs.

Services:

• Bookmarks are included in the creation of SDTM CRF annotation.
• Study data that needs to be converted into submission data tabulation model
• Legacy study data
• Ancillary data
• Trial Design Model tables
• Analysis data is converted in Analysis data model
• Metadata  for both clinical and analysis datasets based on the Case Report Tabulation Data Definition Specification
• Data Reviewer Guide is prepared for the FDA reviewer
• All deliverables are made ready in submission ready eCTD folders