[ HUMAN VALIDATION / STUDY WORKFLOW ]

Study workflow

Follow the six stages of a human validation study, from the initial question to the evidence used for your next decision.

01

Define the question

Begin with the decision the study needs to inform. A candidate comparison, a barrier transport question and an exposure safety question require different evidence.

INPUT
Candidate or material information, existing findings and the intended decision.
WHAT HAPPENS
Translate the question into an endpoint hierarchy and define what is inside the study scope.
OUTPUT
A study brief with objectives, primary endpoints and open feasibility questions.

↳ Use the agreed brief to evaluate model suitability.

02

Select the human model

Model selection connects the tissue biology to the experimental environment. Consider the cell source, culture interface and the biological functions that must be represented.

INPUT
Study brief, tissue or disease context and proposed endpoints.
WHAT HAPPENS
Review model format, culture conditions, reference measurements and chip compatibility.
OUTPUT
A model rationale and a list of suitability checks before the study run.

↳ Carry model constraints into the experimental protocol.

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03

Design the experiment

A useful comparison needs defined controls, treatment conditions and sampling times. Plan these together so the experiment can answer the original question.

INPUT
Model configuration, candidate conditions and endpoint priorities.
WHAT HAPPENS
Define control groups, concentration or exposure conditions, replicates, timing and run acceptance criteria.
OUTPUT
An agreed protocol, sample map and measurement schedule.

↳ Review readiness before model preparation and execution.

04

Prepare, expose and execute

Connect the protocol to the physical system. Model condition and run context must travel with the experimental observations.

INPUT
Approved protocol, test materials and prepared model configuration.
WHAT HAPPENS
Record preparation and baseline conditions, perform the planned interventions and document deviations.
OUTPUT
Run records, treatment history and traceable sample identifiers.

↳ Link every measurement to its sample and run conditions.

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05

Measure and organize the evidence

Bring imaging, electrical signals and assay measurements into the same study context. The relevant readouts depend on the question and model.

INPUT
Experimental samples, run records and the measurement schedule.
WHAT HAPPENS
Collect the selected readouts, check completeness and align measurements with controls and time points.
OUTPUT
A structured measurement set with sample metadata and quality annotations.

↳ Compare results using the analysis plan and document limitations.

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06

Interpret and decide the next step

Interpret the findings in relation to the original decision. A study can identify a response pattern, refine a hypothesis or reveal where more evidence is needed.

INPUT
Measurements, controls, run context and the original study objectives.
WHAT HAPPENS
Review comparisons, variability and limitations with the project team.
OUTPUT
A study report, agreed data package and recommendations for follow-up questions.

↳ Use the evidence to plan confirmation studies or the next development decision.

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