Prepoint™: map, measure, predict.
Digital endpoints for clinical trials, from first-in-human to Phase 2 decision.
The answer to Phase 2 is found in Phase 1.
Most failures are visible early. Wrong dose, wrong patients, or an endpoint too blunt to see change — all three can be tested in Phase 1. [Source 1]
The tools are ready; coordination isn’t. Digital endpoints stall between clinical, statistical, regulatory and digital teams. [Source 4]
Phase 1 is the right place to start. FDA allows exploratory digital endpoints to rely on existing or bridging evidence, while pivotal endpoints need prospective validation. Phase 1 builds that evidence at low risk. [Source 5]
Your science. Our measurement. One plan.
1
Map
Prepoint Map assesses whether and how your drug’s effect can be measured. Your scientists review and sign off.
2
Design
Endpoints, devices and go/no-go criteria built into your protocol.
3
Measure
The module runs alongside your study, from site training to data quality.
4
Decide
A readout that answers Phase 2’s questions, plus the validation evidence to take the endpoint further.
Prepoint Map · Early access
Is your drug measurable?
Before you design a study, know whether your drug’s effect can be seen in humans — and what it will take to prove it.
Prepoint Map assesses your asset across the development path: the aspects of disease your mechanism should change, the measures that could detect it at each phase, what Phase 2 would need, and where the risks lie. Each asset receives a standardized measurability score, comparable across programs.
For biotech leaders setting clinical strategy, investors assessing assets, and pharma teams evaluating in-licensing. Included with every Prepoint Measure study.
Prepoint Measure · Available now
Function and brain activity, measured.
What we measure — selected for your mechanism and population
- Brain activity — quantitative and sleep EEG, including pharmacodynamic signals in healthy-volunteer studies.
- Speech and voice — motor speech, intelligibility, language.
- Movement — gait, real-world activity, tremor, fine motor and upper-limb function.
- Sleep and circadian rhythm.
- Eye movements, respiratory function and digital cognition.
- Connected to your biology — our AI links your existing biomarker data to functional change.
What’s included, end to end
- Design — context of use, endpoint justification, device selection, validation plan, protocol and analysis-plan language, regulatory strategy.
- Set-up — device configuration and version lock, data flow and security, ethics and site materials, patient training tested with the people in your study, logistics.
- Conduct — onboarding, wear-compliance monitoring, real-time data quality, change control.
- Readout — AI-driven analysis, integration with your clinical and biomarker data, go/no-go readout, and a validation dossier for regulators.
Device-agnostic: we choose the right technology for your question, not the one we sell.
Built on programs in neurology, neuromuscular disease and oncology.
Prepoint Predict · In development
Forecast Phase 2 from Phase 1.
Models that use the digital trajectories in your Phase 1 to project Phase 2 effect size, sample size and duration — so the go/no-go rests on numbers, not hope.
Every prediction is tested.
Each Prepoint recommendation is logged as a prediction and checked against later results. AI models are assessed for credibility in line with FDA’s risk-based approach.
Your science stays yours.
Secure, private environments. Your data is never used to train public AI. Your scientists sign off every plan.
Start with one study.
Add Prepoint Measure to the Phase 1 you’re already planning, as an exploratory endpoint — low risk, clear criteria. Your data stays yours.