Skip to content
Navidence Logo_White_Defining
 

 Define once.


Trust Everywhere.

 

 

 

 

Definitions drive the journey from Data to Evidence.

  • Increasing volume and access to Health Data does not equate to meaningful evidence and insights.
  • Precision, Consistency and Trust in definitions is key to unlocking the power of health data for research.

Definition Centric Study Design.

  • Adjusting to definition centric study design can be time and resource intensive.
  • Research teams need effective, and efficient methods and tools to align study design with data science.
  • Deploying CODefs (Computable Operational Definitions) is key to this evolution.
 

The Navidence Platform

Providing research teams with the tools to take the guesswork out of defining your data needs.

Bring precision and consitency to the development of Study Design and Fit-4-Purpose Real World Data Assessment, through Computable Operational Definitions (CODefs). 

Drive trust through expert curated definitions that are contextualized with scientific literature and algorithm validation metrics. 
Navigate Code Lists Logo
Navigate CODefs Logo
Design Studies Logo

Definitions Matter

 
 CODefs drive improvements in how we design studies, perform fit-for-purpose data assessment and respond to stakeholders including regulators, HTA authorities, data sources and the wider research community.
CODef Black

A Regulatory Requirement in the

Age of Data

 
FDA guidances in 2021, 2023 and 2024 and ICH M4 guidances in 2025 all outline expectations that data definitions composed of standardized and mapped data elements and phenotype algorithm should be made available for each study design.
FDA-Quote-Logo-Quote-1-July-2024 (1)
FDA-Quote-Logo-Quote-2-July-2024 (1)
FDA-Quote-Logo-Quote-3-July-2024 (1)
FDA-Quote-Logo-Quote-4-July-2024 (1)
ICH-M4-Quote-1
ICH-M4--quote2
ICH-M4--Quote3
ICH-M4-quote-4