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N1® - Novel Endpoints & Digital Biomarkers

Enabling a fuller and more precise picture of patients' disease and response to treatment

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Digital Biomarkers & Novel Endpoints

The N1 Platform leverages digital technologies to help biopharmaceutical companies figure out whether a treatment actually works, for whom, when.

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ePROs

Capture electronic Patient Reported Outcomes

Benefit from higher-quality, consistent data that you can have confidence in.

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Engagement

Personalized messages and automated reminders to improve compliance.

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Data quality

Logic sequences to prevent inconsistent or conflicting data, if applicable.

Active Tasks

Novel insights beyond clinical scales

Invite users to perform activities in their home under partially controlled conditions, using smartphone sensors to collect data.

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Captured at home

Data is captured in the patients' natural environment, not in a clinical trial site.

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Gamification

Strategies borrowed from successful mobile games improve retention.

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Passive Monitoring

Capture data continuously from smartphone sensors

Unlock insights from passive monitoring data (e.g. effects of disease on everyday motor behavior).

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Activities

Track activities like gait, mobility & sociability or mood from sensors and smartphone usage.

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Longitudinal Data

Create longitudinal profiles and better describe natural history of disease.


Choose from a growing list of digital outcome measures

 

 

Discovery
Analytical Validation
Clinical Validations*
CDx Approvals†

Range of Motion

 

Gait and Balance

 

Tapping Speed

 

5 U-Turn Test (5UTT)

 

Timed Up and Go Test (TUG)

 

Timed Walk

 

Fitness

 

Spatial Memory

 

Stroop Test

 

Trail Making Test

 

Paced Serial Addition Test (PSAT)

 

Tower of Hanoi

 

Reaction Time

 

Sustained Phonation

 

Speech Recognition

 

Speech-in-Noise

 

Tone Audiometry

 

dBHL Tone Audiometry

 

9-Hole Peg

 

Amsler Grid

 

Passive monitoring

Various measures from smartphone sensors (e.g. physical activity, location, mood)
Research / Investigational Use Companion Diagnostic (CDx)

* More details about indications & Context of Use (COU) available upon request † More details about non-research / non-investigational use in Europe & US available upon request

The N1® Platform

N1® is a secure, scalable and GCP-compliant end-to-end platform to collect novel endpoints and digital biomarkers.

[Click the orange circles Icon For Circle for details]

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Solutions for Clinical Development

Data generated by N1 can improve early phase pipeline portfolio decision making, and reduce costly late-stage failures.

Data-Driven Early Phase Decisions

The most important decisions relating to a drug candidate are founded on the data emerging from early phase proof-of-concept trials: Do we believe it will work in pivotal trials with regulatory endpoints that will likely cost hundreds of millions of dollars? What should be the design of those pivotal studies?

N1 can generate data to answer these high-stakes questions.

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Digital Biomarkers & Endpoints

In the absence of well-established and validated biomarkers of diagnosis, disease progression or treatment response, the primary means for assessing the efficacy of novel therapies are often a combination of clinician-administered, rater-dependent rating scales and subjective patient-reported outcomes. In addition, these conventional clinical study designs, where only intermittent evaluations occur, often only allow for snapshot assessments of enrolled patient, with long periods during which important data points are not collected.

This all contributes to late-stage failures that may be avoided by digital biomarkers and endpoints.

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Technology-Powered Enrichment

Identifying participants in the early, pre-clinical or prodromal stages of certain disorders can be challenging, time-consuming and expensive.

Digital biomarkers enable remote screenings of trial participants, and reduce on-site screen failure rates and costs for both sites and sponsor. In addition, testing a new therapy only in a digital-biomarker-positive subgroup can be beneficial for various reasons (e.g. reduced sample size; avoiding dilution of the results due to the absence of biomarker-negative patients).

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Solutions for Medical Affairs & HEOR

Data generated by N1 can help demonstrate real-world effectiveness, patient benefit and value.

Smart Registries

N1 can be used to generate post-launch data from registries, e.g. when required by regulators or HTA agencies (for early access approvals, conditional approvals or approvals under exceptional circumstance)

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Virtual Phase IV Trials

Trials with digital endpoints collected in the patients' homes can reduce the number site visits or make them obsolete at all, introducing unmet efficiency for phase IV trials (e.g. generating data for lifecycle management)

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Next-Gen HRQoL

Patient burden and health related quality of life (HRQoL) is notoriously difficult to assess. N1 can collect disease-specific, technology-generated data reflecting qualitative and quantitative patient burden.

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Get in touch with our Business Development team

We are happy to receive your inquiry

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