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Strategic Framework for Digital Measure Development

The Strategic Framework is a critical tool for decision making and considers the entire end-to-end journey for building measures. This framework brings efficiencies by incorporating synergies from existing assets, compatible initiatives and potential collaborations. The process to use the framework is simple and outlined below. The DEEP expert team, led by your assigned Science Liaison will support your teams along this journey all the way to the finish line. 

Process to use the framework

1

We work to understand the unmet need and context of use of the measure.

2

We help compile and centralize all of the relevant assets in the DEEP catalog and can perform a gap assessment to see what is still required to enable the intended use of the measure.

3

We make specific recommendations for DEEP missions and potential collaborations and efficiencies to achieve the end goal.

This approach allows all stakeholders to have a comprehensive understanding of the completeness and maturity of the evidence and solutions for the specific measure. These steps help inform the rest of the strategy, helps identify synergies, optimize the rest of the development journey and help avoid unproductive overlap. 

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Missions that enable development of digital measures

Any of the following missions can be launched to enable development of the digital measures that are required. 

Discovery / Preclinical Phase

Discovery Mission

  • What is it?
    Identifies relevant digital measures and measurement solutions from internal and external sources.​

  • How does DEEP support it?
    Locates relevant assets across the organization, structures information into the DEEP catalog stack model to provide a complete picture of components, evidence, regulatory intelligence, and gaps


Measure Definition Mission

  • What is it?
    Repurposes measure definition content and regulatory intelligence from similar contexts of use.​

  • How does DEEP support it?
    Supports repurposing of content, identification of evidence gaps, facilitates collaboration to generate additional evidence and seek regulatory validation.

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Discovery / Preclinical & Phase 1

Regulatory Validation on Measurement Definition Mission​

  • What is it?
    Collects evidence supporting the new measure, engages with regulatory agencies for feedback.

  • How does DEEP support it?
    Provides structured content management (DEEP Stack Model), collaboration tools (Digital Briefing Book, Evidence Dossier, Workspaces).

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Regulatory Mission on Analytical/Clinical Validation study design 

  • What is it?
    Constructs study design concept, engages with regulatory agencies for feedback.​

  • How does DEEP support it? 
    Enables lifecycle management, repurposing of information across contexts and solution profiles, facilitates expert collaboration.

Phase 1

Target Solution Profile Definition Mission

  • What is it?
    Establishes key characteristics, technology, and performance requirements for solutions.

  • How does DEEP support it?
    Establish key characteristics for solutions to capture this novel measure. Standardize the related technology and performance requirements. Characterize the algorithm and data processing pipeline. Establish an approved performance standard. This helps establish an approved standard for solutions used to capture data for this modality and implementations consistent with the standard would not require further approval. 


Analytical Validation Mission

  • What is it?
    Demonstrates analytical performance of the solution and informs analytical standards​

  • How does DEEP support it?
    Provides structured content management (DEEP Stack Model), collaboration tools (Digital Workspace, Briefing Book, Evidence Dossier). Links results to TSP, provides collaboration tools, enables matching of validation needs to 3rd party services.

Phase 2
 
Clinical Validation Mission

  • What is it?
    Establishes qualitative and quantitative evidence to support interpretation of the measure.​

  • How does DEEP support it?
    Provides structured content management (DEEP Stack Model), collaboration tools (Digital Workspace, Briefing Book, Evidence Dossier). Links results to TSP, provides collaboration tools, enables matching of validation needs to 3rd party services. 


Phase 3 & 4
 
Regulatory Validation on Digital Measurement Solution Missions

  • What is it?
    Formal regulatory qualification of a novel methodology or drug development tool.​

  • How does DEEP support it?
    Provides structured evidence building, integrates with catalog, facilitates efficient management of qualification missions across different agencies.

Building Digital Measures

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