Data Mapping and Standardization
Increasing Value by Making Data Usable
eClinical Solutions’ mission is to make clinical data mapping, acquisition, standardization, aggregation and analysis absolutely simple and easy.
How do we achieve this with data mapping and standardization?
By helping organizations realize the intrinsic value of their clinical data—simply by making it useful for analysis and acceptable for submission to regulatory bodies.
We are experts in the mapping of both ongoing and legacy data to Sponsor-specific standards in compliance with CDISC SDTM. Our efforts have shortened submission timelines and improved the Sponsor’s ability to perform efficient analysis, reporting and creation of “submission ready” data sets.
- Develop data mapping methodologies
- Provide SDTM and ADaM mapping, programming and validation services
- Create submission-ready data that meets reporting needs
- Ensure QA compliance of mapped data against submission requirements
- Map-controlled terminology related to the data
- Integrate mapped data into Sponsors’ reporting environment
- Define and validate define.xml and define.pdf
- Generate SDTM-annotated CRFs compliant with CDISC guidance and FDA requirements
- Generate both SDTM and ADaM Reviewer’s Guides accompanying submissions
- Organize content into a structure aligned to submission requirements, facilitating incorporation into the submission
- Map data into clinical data repositories
- 4th Global QA Conference & 30th SQA Annual Meeting
- Electronic Data Capture