The U.S. Food and Drug Administration has issued a guidance recommending that sponsors submit clinical trial data using the Study Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC). This guidance is intended to expedite the regulatory review cycle.
PPD has completed more than 100 studies in the SDTM format as well as conducted numerous studies using the CDISC Analysis Data Model (ADaM) and Laboratory Data Model (LAB) standards.
There are multiple benefits to using PPD’s CDISC services including:
- Rapid CDISC implementation by an experienced team
- Ability to meet compilation standards for both clinical data systems and regulatory submissions
- Improved data quality across the globe
- Expedited review of regulatory submissions
Comprehensive CDISC Services
PPD has been a corporate sponsor of CDISC since 2000, and our data management tools and services are fully compliant with CDISC standards. Our services include:
- Consulting expertise to support clients in meeting the challenges of CDISC compliance
- Transforming legacy data to CDISC-compliant formats
- Full submission-ready ADaM databases
- CDISC-compliant statistical deliverables