CDISC, a global non-profit organization has established data standards to support the acquisition, exchange, submission and archival of clinical research data and metadata. Currently, the FDA and PMDA require CDISC standards for all submissions and non- compliance could potentially receive a Refusal to File (RTF).
ACI Clinical has been a CDISC Registered Solutions Provider for more than a decade. We have the expertise and resources needed to handle CDISC data standards conversions and integrations of all sizes, either for specific programs getting ready for submissions, or across entire enterprises.
Our CDISC Standards implementation and legacy data conversion services include:
- 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
- Data Safety Warehousing
Given the complexity in converting SDTM and the associated generation of analysis datasets, our experts are available to consult with you on the proper way to plan and implement CDISC conversion leading up to a submission.