Human Data Trials

The Next Era of Drug Development

What if we could gather human-relevant data earlier — before first-in-human trials, without patient risk?

The problem we can’t ignore

We can cure mice of any disease we can imagine.

But when it comes to humans, we’re lost.

$2B+

To bring a single new drug to market

90%

Failure rate for clinical trials

~15+ yrs

Time from discovery to clinical approval

We don’t understand human biology because we don’t have a complete picture

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Petri dish models are too simple

Petri dish data can’t replicate patient complexity and variability.

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Animal biology can’t predict human outcomes

Key differences in physiology, metabolism, and immune response limit the relevance of animal data in drug development.

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Clinical trials are Too risky

Patient risk severely limits the data we can collect from clinical trials.

A paradigm shift in drug development is gathering momentum—from animal models to human systems

Legacy animal model based approaches

Limited translatability to human biology

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Animal models

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Emerging alternatives

Fragmented with limited solutions

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Organ-on-chip

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Organoids

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IPSC derived models

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Integrated Human Data Platform

More predictive, faster insights, and clinically relevant

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Learn About Our Human Data Stack

Scientific and regulatory limits, plus rising costs create pressure for integrated, scalable human systems

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Cost pressures

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Faster timelines to IND

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Faster timelines to IND/NDA

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Ethical / ESG pushback on animal use

Human Data Trials are the next frontier

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and donated human organs revived on perfusion are the Rosetta Stone

How Human Data Trials Work

1

Purpose

Work together with Revalia to define your Human Data Trial area of interest. From discovery to ADME/Tox, biodistribution, and efficacy, Revalia’s Phase 0 Trials can help elucidate your most pressing pre-clinical questions.

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2

Trial design

Go through technical workshops with Revalia to get to your preferred trial design and establish your key endpoints.

3

Donor enrollment

Once you’ve worked with Revalia to finalize a trial design, Revalia then engages our OPO partners to screen donors that would be appropriate to enroll, making sure we maximize the gift with every donation.

4

Trial execution

Revalia executes the trial with clinical precision, ensuring all relevant samples and data are captured with high fidelity.

5

Data generation

Revalia processes samples to collect rich multi-modal data spanning molecular signatures, imaging and histopathology, and organ-level functional outputs.

6

Data analysis & interpretation

Revalia analyzes and synthesizes trial findings to extract meaningful biological and translational insights.

7

Strategic decision making

Our partners then use the results to determine whether to advance the program, modify the approach, or deprioritize based on real human tissue response.

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Revalia makes tomorrow’s Human Data Stack possible today by

01

Sourcing the data that only donated organs that can generate

02

Providing the software infrastructure to ingest and manage human data

03

Incorporating collaborative tools to break down the institutional barriers that hold back research on human data

Bridge the gap between biology and breakthrough

Ready to accelerate your next program?