Draw a clear roadmap for accelerated FDA review
Provide reviewers with a clear understanding of your data. Pinnacle 21 Enterprise creates define.xml files quickly and easily, while guaranteeing FDA and PMDA compliance.
Create 100% compliant Define.xml 2.0 with ease
Extract Metadata and Merge with Standards
Scan datasets to extract domain, variable, codelist, and value level metadata and then merge it with standards. Finally, scan annotated CRFs to automatically populate origin page numbers.
Compare Studies and Versions
Compare two studies to see the differences between them. You can even compare two versions of the same study to see how it changes over time.
See issues highlighted in real time if you should enter something invalid or erroneous.
Did You Know?
A poorly documented define file is one of the biggest issues noted by FDA reviewers. In fact, 77% of studies loaded into FDA Janus Clinical Trial Repository (CTR) failed on first attempt, with define.xml being the main contributor.
What our tool does
- Creates Define.xml for SDTM, SEND, ADaM
and Analysis Result Metadata
- Generates value-level metadata easily
- Imports annotated CRFs intuitively
- Populates terminology codes effortlessly
What our tool doesn't do
- Require you to know programming or xml
- Demand that you be fluent with macros or scripts
- Force you to do it by hand
- Frustrate and confuse you, and waste your valuable time