Our services include:

• Creation of customized CDISC solutions

• Building new CDISC SDTM compliant databases

• Creation of CDISC SDTM domains from various customer-defined data standards

• Mapping of studies from legacy to CDISC standards for ISS/ISE reporting and FDA submission

• Converting CDISC ODM XML to SAS® datasets and vice versa

• Creation of the 'Case Report Tabulation Data Definition Specification', (DEFINE.XML) for submission to the FDA

• Statistical programming using ADaM derived datasets as inputs to the SAS® report code