Data Standardization Services
Through Pinnacle 21’s clinical data standardization services, we’ll ensure that your study data and supporting documentation are compliant with FDA’s requirements, and ready to support the regulatory review process. When the reviewer fully understands your data and has all the information needed, your review will be more efficient and effective — enabling you to get your product to market sooner.
- Standardizing studies to SDTM and ADaM
- Data Fitness Assessment
- Annotation of CRF/eCRF to SDTM
- Define.xml preparation for SDTM and ADaM
- Study Data Reviewers Guide and Analysis Data Reviewers Guide development
- QC of SDTM, ADaM, DEFINE.XML, Annotated CRF and Reviewers Guides