Who is clinical study design and decentralized trial infrastructure for?
Digital health companies that need evidence for a claim, a payer, or a regulator; pharma teams adding digital endpoints to a trial; and academic groups running multi-site or decentralized studies. Our founder holds a PhD in epidemiology and clinical research and has built the platforms behind remote clinical studies, so the design and the data capture are planned by the same person.
What does clinical study design and decentralized trial infrastructure include?
- Study design and endpoints — question, population, comparator, and endpoints that answer the question with the fewest participants.
- Digital endpoint validation — verification, analytical validation, and clinical validation (the V3 framework) planned for each digital measure.
- eCOA and ePRO — instrument selection, schedule, and implementation that preserves validity on a phone.
- Sample size and analysis plan — a statistical analysis plan written before data collection, with the biostatistics to back it.
- Data capture specification — what is collected, from which device or system, at what cadence, and in what model.
- Decentralized trial infrastructure — consent, identity, remote capture, wearable and EHR linkage, and monitoring.
- IRB-ready documentation — protocol sections, data management plan, and the security description the IRB will ask for.
How does a clinical study design and decentralized trial infrastructure engagement run?
- Question and constraintsWhat the evidence must support, for whom, by when, and with what budget.
- DesignEndpoints, instruments, sample size, and analysis plan, iterated with your clinical leads.
- SpecificationData capture and infrastructure specification your engineers or ours can build.
- SupportOngoing scientific input through execution, as co-investigator where appropriate.
Frequently asked questions about clinical study design and decentralized trial infrastructure
Can you serve as a co-investigator?
Yes, where the study and the institution allow. For many engagements an advisory or design role is enough; for grant-funded studies a named co-investigator with the relevant expertise is often the better structure.
Do you run the study?
We design it and build or specify the infrastructure. Site operations, recruitment, and monitoring are usually run by you or a CRO; we can help select and manage the CRO.
What is the V3 framework?
A widely used framework for evaluating digital measures in three stages: verification of the sensor, analytical validation of the algorithm, and clinical validation of the measure against the clinical concept. We plan all three up front.
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Scope it in 30 minutes
Book a scoping call and we'll name the smallest engagement that moves you forward. Most teams start with the fixed-scope Initial Audit.
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