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RWE Design in the Age of Data

 

Trust

Transparency = Trust.

 

Computable Operational Definitions (CODEF Libraries) can increase transparency in your RWE Design and your assessment of fit-for-purpose RWD.

"Small differences in the choice of operational definition … may have a large impact on study results.”

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Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices | December 19, 2023.
 
 

Transparency at the study data element level

Use CODEF Libraries to map EACH study element to EACH data variable.

Increased level of transparency drives increased trust in both the scientific rationale and data science behind your study design.

The Power of CODEF Libraries.

 
 

Precision in Stakeholder Engagement

Regulators and other external stakeholders are increasingly demanding greater levels of precision and transparency in discussions about the potential for use of Real World Data in studies.

 

RWE Sherpa allows you to address RWE Design in the Age of Data and gives you the ability to show precisely how your study design aligns with Real World Data Sources.

FDA-Quote-Logo-Quote-4-July-2024 (1)

Click below to see more ways The Power of CODEF Libraries can drive benefits for your organization.

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A single source of truth across your organisation for operational definitions, code lists and value-sets.
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Use definitions, code lists and value-sets that are validated against scientific, regulatory and industry standards.
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Remove the need to reinvent the wheel in generation of code lists and value sets for every study.

Reduce the time to create study specific code lists and value set from weeks to days
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Use definitions, code lists and value-sets that are validated against scientific, regulatory and industry standards.
Click to learn more.