The Clinical Data Interchange Standards Consortium (CDISC) is a set of international standards developed to collect, report, and analyze clinical trial data in a homogeneous and reproducible manner. The main CDISC standards are CDASH, SDTM, and ADAM, which respectively focus on the collection, submission, and analysis of clinical study data. Sponsors submitting data to regulatory authorities will need to apply CDISC standards to their clinical trial datasets.
We are specialized in providing CDISC services and Our capabilities include the implementation of CDASH, SDTM and ADAM standards. We have done CDISC implementation in in various therapeutic areas and our dossiers accepted in many regulatory agencies.
We provide the following CDISC Services .
- Data Visualization Assistance
- Consulting on CDISC implementation
- Preparation of Submission Compliant Datasets
- Mapping data into CDISC and SDTM standards
- CDASH compliant EDC builds in Clinical Database