CDISC, SDTM, and ADaM Compliance
The U.S. Food and Drug Administration required that sponsors submit preclinical study and clinical trial data using CDISC data standards to expedite the regulatory review cycle since December 17, 2016. Pharmapace has provided comprehensive CDISC services to many clients for more than 200 studies with CDISC compliant data packages.
To ensure the consistency and compliance with CDISC standards and to gain efficiency, Pharmapace has built a set of tools to facilitate the SEND and SDTM data mapping and conversion process, define.xml creation, and quality control.
Our Services Include:
- Consulting expertise to support clients in meeting the challenges of CDISC compliance
- Transforming legacy data to CDISC-compliant formats
- Preparing NDAs with full submission-ready SEND, SDTM, and ADaM data packages in SAS transport v5 (.xpt) format
- Creating define.xml and data reviewer’s guide documents for SEND, SDTM, and ADaM data packages
- Preparing the trial summary dataset (ts.xpt) for preclinical legacy studies
- Performing consistency checks, which are beyond Pinnacle 21 validation checks, for define.xml against aCRFs and databases
- Designing clinical databases with the CDASH-compliant eCRFs