Data Standards

With the goal of accelerating the time from data collection through regulatory submission, ACI has developed standardized procedures utilizing validated tools in coordination with current CDISC standards (CDASH, SDTM, and ADaM).  The use of such standards in clinical data processing improves efficiency, reduces costs, and reduces time to delivery.

ACI has successfully delivered SDTM datasets for regulatory submissions in a variety of therapeutic areas. Whether you have a need to convert legacy data in preparation for a regulatory filing, or if you wish to implement CDISC standards throughout your product development life cycle, ACI has the experience and expertise to be your preferred CDISC partner.

 Services Offered:

• CDASH-compliant CRF design
• SDTM CRF annotations
• SDTM and ADaM mapping specifications
• SDTM and ADaM programming and validation
• SDTM and ADaM transport data delivery
• Data integration and standardization for ISS/ISE
• Define.XML creation
• Consulting

ACI is a CDISC Registered Solutions Provider http://www.cdisc.org/rsp