Partner with the industry leaders to meet the demanding regulatory hurdles for label expansions and post-marketing surveillance

Our solution consists of:

  • Conducting regulatory-grade EHR studies for regulatory and reimbursement use
  • Achieving cohort accuracy exceeding 85% as needed for regulatory-grade clinical assertions
  • Providing a turnkey solution including protocol design, data licensing, technology implementation, independent validation, study completion, and publication
  • Incorporating data validation reports to support the regulatory submission process

Our differentiators include:

  • An expert team and products created to leverage advanced technologies and unstructured EHR data to define inclusion criteria, exposures and outcomes for cohort generation
  • Advanced technology leveraging NLP and AI to consistently achieve 90%+ recall and precision
  • Thought leadership including engagement with NIH, NSF, FDA, Congress and leading biopharma

Our deliverables include:

  • Execution of a complete regulatory-grade EHR study including publication and submission support
  • Incorporation of data validation to ensure study credibility
  • Demonstration of drill down access to engage stakeholders and increase organizational learning

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