An Introduction to CDISC Standards in Clinical Research [Video]

CDISC standards are transforming clinical trial data management by providing a universal framework for capturing, structuring and submitting data from first protocol draft to final analysis. In this video, we’ll break down the core content models (PRM, CDASH, SDTM, ADaM, SEND), the key exchange formats (ODM-XML, Define-XML, Dataset-XML) and practical steps for gap audits, pilot mappings, and automated validation.

At Quanticate, our expert teams of data managers, statistical programmers and regulatory specialists excel in full-spectrum CDISC implementation, from mapping raw data to SDTM/ADaM and generating Define-XML to integrating validation tools and training your staff. We’ll guide you through protocol design, submission-ready documentation and ongoing governance to ensure your next trial runs smoothly and meets global regulatory expectations. Submit an RFI today.