Measure Definition
Obtain evidence to support meaningfulness to patients and relevance to your drug development program.
Regulatory Alignment
Gain acceptance for the definition and early regulatory advice on development, validation and qualification.
Solution Profile Definition
Create and gain approval for technical and analytical standards for future proofing across use cases and technology evolution.
Solutioning
Development, technical verification and evaluation of usability and suitability for your intended use.
Analytical Validation
Develop evidence for analytical performance and create analytical standards.
Clinical Validation
Develop evidence to support the interpretation of the measure.
Regulatory Qualification
Regulatory acceptance / qualification for the measure and related standards.
Discover Measure Building Blocks
Measure definitions, solution profiles and specific technology content is structured for re-use.
Assemble Your Measure
Compile and customize everything you need for your specific purpose and context of use.
Connect Stakeholders & Content
A secure space with productivity tools for internal and external cross functional teams to advance digital measure projects.
Regulatory Success
- Optimize acceptance with global authorities (FDA, EMA, HTA Bodies)
- Proactive, solution oriented regulatory policy to shape the environment
- Drive acceptance and qualification of measures
- Production of regulatory content (briefing books, meeting requests, etc)
Business Case
Measure Strategy
Operational Planning
All the components you need to use your solution in a clinical program, with a playbook and checklists to guide implementation.
Content Services
AI Supported Services
Benefits:
- DEEP engineering delivers safe deployment of AI
- Humans in the loop ensure high quality
- AI and agents ensure completeness in complex tasks
- Gain up to date results in a fast evolving landscape