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CODefs.

 

Computable Operational Definitions. 

 

 

 

 

A regulatory requirement for

RWE Design in the Age of Data

FDA Guidance for Real World Data in September 2021 and December 2023 directed researchers regarding factors affecting their assessment of the reliability and relevance of real-world data, and outlined their expectation on how these should be addressed in study protocols. 



The guidance specifically recommends the need for Conceptual Definitions and Operational Definitions (CODef) to be outlined for study design elements (e.g. inclusion/exclusion criteria for study population, exposure, outcomes, covariates).

Click on the video below to hear more about the regulatory landscape driving deployment of CODefs in RWE Design and RWD Assessment.

 

Align Science with Data

 

 

Computable Operational Definitions (CODef) allow the translation of Scientific Objectives, into specific definitions which align and enhance access and use of Real World Data for research.

 

Click on the video below to learn more about how to align of CODefs to your Study Design Elements.

 

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Our RWE SherpaTM Platform provides access to a range of indication-specific CODef Libraries.

 
Industry conversations
 

Computable Operational Definitions (CODef)

Power-of-CODef_observtory_ISPOR_web

"Computable Phenotypes" - Understanding Their Importance in Regulatory Submissions of RWE.

Our CEO Aaron Kamauu, spoke at ISPOR 2024 alongside Marie Bradley from the FDA and Scott DuVall from US Department for Veterans Affairs, to showcase how the Power of CODefs can be used to illustrate fit-for-purpose use of real world data sources to regulators.

 

Presented at ISPOR Annual Meeting, Atlanta. 4th-8th May 2024.

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Datavant-ISPOR-poster_web

Objective Fit-4-Purpose Assessment of Real-World Data for Evidence Generation in Type 2
Diabetes Mellitus: A Trial Tokenization Approach

The Navidence Team working alongside our colleagues from Datavant showed how the use of CODefs can derive significant value in the assessment of the value of RWD Tokenisation, as well and providing robust evidence of quality and fit-for-purpose to regulatory agencies.

 

Presented at ISPOR Annual Meeting, Atlanta. 4th-8th May 2024.

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ISPOR 2022 AZ Navidence Paper-1

Development of Computable Operational Definitions to Maximize Comparability & Consistency Across a Multi-Data Source Global Real-World Effectiveness Program

The Navidence Team working alongside a team from AstraZeneca to develop source-agnostic Computable Operational Definitions (CODef) to support a multinational, multi-data source real-world effectiveness program.




Presented at the 39th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) | August 23–27, 2023, Halifax, Nova Scotia, Canada

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View all thought leadership presentations from Navidence.

 

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