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.

Extract Metadata and Merge with Standards

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.

Compare Studies and Versions

Real-time Validation

See issues highlighted in real time if you should enter something invalid or erroneous.

Real-time Validation

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

See Pinnacle 21 in Action

Request a demo