Your clinical study summaries and reports are ready for submission. Is your data?
Early phase through submission, it is now more critical than ever to know that your clinical trial is well managed and that regulatory expectations are met with expertise in cGCP and CDISC standards. The FDA currently highly recommends CDISC data standards, and will require all submissions to be in CDISC-compliant formats by 2017. Your pathway to submission will require expert support; find out why SDC is The Right Fit For You.®
SDC is a CDISC Registered Solutions Provider for ADaM, CDASH, Define-XML, SDTM, Study / Trial Design Model, and Controlled Terminology Standards.
Our entire team's continued education on CDISC standardization is strongly encouraged and supported by SDC management. In addition, several SDC staff actively support CDISC in the development of future standards by participating on CDISC teams and PhUSE industry working groups.
Standard CDISC Services
- CDASH Compliant CRFs/eCRFs
- Integration of Controlled Terminology
Submission-Ready Data Services
- OpenCDISC Validation
- Legacy Data Conversion
SDC standardly employs the following process to ensure you receive high quality data with traceability throughout your study.