We are an active member of the Clinical Data Interchange Standards Consortium (CDISC) and a Registered Solutions Provider. CDISC data standards are now applied to various phases of clinical research and are rapidly becoming industry standard. Starting at the end of 2016, the SDTM, ADaM and Define-XML will be the only supported formats for all clinical data submitted to the FDA.
As an industry leader, we continuously review trends and changes to implementation guidelines with CDISC in order to assist our clients in the challenges of adhering to new standards.
In addition to a suite of proprietary validation checks, we use OpenCDISC, an open source technology, to load, review, and validate SDTM data and Define.xml files. You can therefore submit your data to regulatory agencies with confidence.
Our team has converted data from numerous clinical trials, in diverse therapeutic areas, to CDISC-compliant SDTM and ADaM data sets, as well as designed CDASH compliant forms and databases for streamlined data management and reporting.
To ensure your standards are successfully adopted in every phase of development, we provide:
- CDISC-compliant SDTM data sets for your legacy study data and the migration to submission-ready format of data from ongoing trials
- Clinical Data Acquisition Standards Harmonization (CDASH) compliant CRFs for paper-based clinical trials and eCRFs for electronic data capture (EDC) clinical trials, in their proper design format
- Analysis Data Model (ADaM), CDISC-compliant data sets for statistical analysis
Additional CDISC services
- Gap analysis of study documents and data
- CDASH annotated case report forms
- SDTM annotated case report forms
- Trial design compliant data sets
- Generation of Define.xml and Define.pdf files
- Utilization of OpenCDISC
- Comprehensive quality control measures
- Strategic consulting