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## ** 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](https://navidence.com/hs-fs/hubfs/Navigate%20Code%20Lists%20Logo.png?width=2000&height=935&name=Navigate%20Code%20Lists%20Logo.png "Navigate Code Lists Logo")

![Navigate CODefs Logo](https://navidence.com/hs-fs/hubfs/Navigate%20CODefs%20Logo.png?width=2000&height=935&name=Navigate%20CODefs%20Logo.png "Navigate CODefs Logo")

![Design Studies Logo](https://navidence.com/hs-fs/hubfs/Design%20Studies%20Logo.png?width=675&height=373&name=Design%20Studies%20Logo.png "Design Studies Logo")

[Learn more about the Navidence Platform](https://navidence.com/-platform?hsLang=en)

## 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](https://navidence.com/hs-fs/hubfs/CODef%20Black.png?width=500&height=203&name=CODef%20Black.png "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)](https://40686559.fs1.hubspotusercontent-na1.net/hub/40686559/hubfs/FDA-Quote-Logo-Quote-1-July-2024%20(1).jpg?width=1200&length=1200&name=FDA-Quote-Logo-Quote-1-July-2024%20(1).jpg)

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