CDISC Standards Implementation

Perform a CDISC standards maturity assessment and lead/support in the creation of a standards implementation plan.

Creation of CDASH CRF Libraries, SDTM mappings, Edit Checks, Controlled Terminology and documentation.

Provide project management support defining standards work packages, responsibilities and managing requests and deliverables.

CDISC Standards Governance

Develop/support standards governance processes within teams and organizations to flexibly deliver standards.

Join/lead Standards Governance Teams as CDISC CDASH and SDTM Expert.

Support on complex CDISC mappings. Leveraging a professional network to escalate to CDISC and regulators for input when necessary.

CDISC Trainings and Consultancy Services

Provide CDISC trainings tailored to the organizations current standards competencies and support development.

CDISC and CDM Applications

CDISC MDR (Metadata Repository) vendor selection and implementation.

Develop CDISC applications, programs and tools to support standards deliverables and management.

Contact

For more detailed information please contact on info@clinbuild.com or +49 176 578 16593.

About Us

ClinBuild consultants are expert in their CDISC foundational standards area, active members of the CDISC teams, authors on the foundational documentation, and authorized trainers. For more information see the experience page.