CDISC Migration

Seamlessly aligning your data with global CDISC standards

Experienced in both large-scale and smaller mapping projects, we work across all common clinical data formats and stay current with evolving CDISC standards.

Specialized in migrating both current and legacy datasets to SDTM and ADaM formats, fully aligned with global regulatory requirements.

We manage the full spectrum of data standards, from mapping TLFs to building submission‑ready, CDISC‑compliant regulatory packages.

At Intego Clinical, we’ve guided numerous pharmaceutical industry partners through successful CDISC migrations to transform both current and legacy data into fully compliant SDTM and ADaM formats. Our expert team of clinical data professionals is skilled in mapping a wide range of data formats to align with the latest CDISC standards for greater consistency, accuracy, and submission readiness. As a global Biometrics CRO, we support the full data migration process, starting with the development mapping strategies and establishing internal data standards to the preparation and submission of regulatory documents. As regulatory bodies like the FDA, EMA, PMDA, and others require or strongly encourage CDISC-compliant submissions, our expertise helps sponsors avoid costly delays and move confidently toward approval.

The Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit organization responsible for defining industry standards for clinical data collection, analysis, and regulatory submission. For sponsors seeking approval from agencies like the FDA and PMDA, adherence to CDISC standards (e.g., SDTM, ADaM, and define.xml) is essential to avoid delays and ensure successful submissions.

Intego Clinical supports the full spectrum of CDISC conversion needs. Our clinical data professionals expertly translate internal data formats into compliant SDTM and ADaM datasets, and we manage all related components, including define.xml and TLF outputs, among others.

As a recognized leader in CDISC mapping and compliance, Intego Clinical maintains direct access to the latest CDISC documentation, releases, and industry standards. We apply this knowledge to create customized mapping strategies based on your unique data architecture, and we advise on broader data integration and standardization initiatives across your organization.

Intego Clinical manages both large-scale and targeted mapping projects across all common clinical data formats, delivering clean, consistent datasets aligned with SDTM, ADaM, and define.xml standards. With rigorous internal quality control processes and a team of CDISC-savvy experts, we continue to be a trusted partner for reliable, regulatory-ready data transformation.

Proud CDISC Gold Members

Intego Clinical is proud to be a Gold Member of CDISC, an organization committed to advancing global data standards that enhance the quality, consistency, and efficiency of clinical research. These standards ensure that clinical data is structured, interpretable, and submission-ready across studies, systems, and regulatory bodies.

Our CDISC Migration Services:

Mapping of current and legacy clinical data to CDISC-compliant formats (SDTM and ADaM)
Recreation and validation of SDTM, ADaM, and define.xml datasets
Development of complete regulatory submission packages, including ISS/ISE reporting
Recreation and QC of Tables, Listings, and Figures (TLFs)
Strategic guidance on CDISC implementation and legacy data conversion frameworks
Tailored data transformation and standardization solutions to meet sponsor-specific needs

Ready to see what we can do for you?

Let’s talk!