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CDISC Services for Clinical Trials

What is CDISC in Clinical Trials?

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 (such as the FDA) will need to apply CDISC standards to their clinical trial datasets.

Sofpromed’s CDISC Services

Sofpromed is a clinical research organization (CRO) specialized in providing CDISC services for biotech and pharmaceutical companies worldwide. Our CDISC capabilities include the implementation of CDASH, SDTM and ADaM standards. Sofpromed’s CDISC services are oriented to phase I-IV clinical trials in various therapeutic areas such as oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious, and respiratory diseases, among others.