navify® digital solutions | Digital Biomarkers solution

Overview

A trusted solution proven by over a decade of research and global trial experience

Built on one of the largest neurodegenerative digital datasets across clinical trials: over 12,000 months of Parkinson's disease data from hundreds of participants and over 16,000 months of Huntington's disease data from more than 1,000 participants. The navify Digital Biomarkers solution* is designed to support optimal decision-making for drug development.

Precise measure of treatment response

Provide frequent, accurate digital measurements to support reliable and valid disease progression data.^2,3

Detecting early signals of efficacy

Generate evidence in Phase I and II studies to accelerate and support confident drug portfolio decisions.^1,4

Designed for patient satisfaction

Elevate the patient experience to ensure high clinical adherence over multiple years.

Documented success at global scale

Deploy proven digital solutions across 30+ Phase I–IV trials, 50+ countries and 100+ sites.

Benefits

Accelerate clinical trials

The navify Digital Biomarkers solution enables sample size reduction translating into reduced patient burden, cost savings and time efficiencies in studies.^6,7

Optimized statistical efficiency

Superior sensitivity compared to traditional, periodic in-clinic assessments provides earlier signal detection and enables sponsors to demonstrate treatment effects with greater confidence and ecological validity^1,2,5. This yields a greater signal-to-noise ratio, revealing subtle progression signals that enable early decision-making on clinical efficacy.^1,2

Demonstrated pathway to sample size reduction

Proof-of-concept modeling and independent research indicate a clear pathway to sample size reduction. Based on specific trial assumptions, a simulated study projected that utilizing a digital primary endpoint could reduce required cohort sizes by up to 70%.⁶ Independent modeling further supports this scenario, suggesting that enhanced statistical power could detect a 30% reduction in disease progression using only 152 participants, compared to over 600 with traditional scales.⁷

Reduced trial timelines and costs

By maximizing statistical power, sponsors have the potential to execute significantly faster studies. Simulated proof-of-concept trial data indicates that utilizing these objective digital endpoints could reduce Phase II trial durations by 16 months – completing in 12 months rather than 28.⁶

End-to-end solution

How it works – for you and your study participants

Built with patients, physicians and neuroscience experts and validated by clinical data, the navify Digital Biomarkers solution is an objective, high-frequency digital endpoint for tracking multi-domain progression, including motor symptoms, speech and cognition in Parkinson's and Huntington's disease clinical trials.

Patient success

User-friendly design drives high overall satisfaction with daily testing, shown in two-year Phase II clinical trials.⁸

Sustained long-term adherence

Good adherence of 5–6 days per week over two years ensures sustained, high-integrity data continuity for your trial.^2,3

Ecological validity

Demonstrate treatment effects with greater confidence by capturing the patient's true daily disease experience.^5,9,10

Built-in data security and patient privacy practices

Backed by a 125-year legacy of financial stability and leadership in diagnostics.

Additional reading

Explore how the navify Digital Biomarker solution is being used in Parkinson’s disease, including the Phase 2 NEULARK trial by Neuron23¹¹ and the Michael J. Fox Foundation Parkinson’s Progression Markers Initiative (PPMI) study.¹²

Read Neuron23 article

Read about PPMI

References and notes

Giboin LS, et al. A digital motor score for sensitive detection of progression in Huntington’s disease. Brain. 2025;148(9):3228-38. https://doi.org/10.1093/brain/awaf127.
Lipsmeier F, et al. Reliability and validity of the Roche PD Mobile Application for remote monitoring of early Parkinson’s disease. Sci Rep. 2022;12(1). https://doi.org/10.1038/s41598-022-15874-4.
Lipsmeier F, et al. A remote digital monitoring platform to assess cognitive and motor symptoms in Huntington disease: cross-sectional validation study. J Med Internet Res. 2022;24(6):e32997. https://doi.org/10.2196/32997
Taylor KI, et al. Exploratory digital outcome measures of motor sign progression in Parkinson’s disease patients treated with prasinezumab. NPJ Digit Med. 2025;8(1). https://doi.org/10.1038/s41746-025-01572-8.
Volkova-Volkmar E, et al. Association between actively and passively monitored gait in early Parkinson’s disease. Presented at: MDS Virtual Congress; 2020. Abstract. Available from https://www.mdsabstracts.org/abstract/association-between-actively-and-passively-monitored-gait-in-early-parkinsons-disease/
Rukina D, et al. Digital health technologies can reduce sample size and enable shorter proof-of-concept clinical trial in Parkinson’s disease. Presented at: AD/PD 2023 International Conference on Alzheimer’s and Parkinson’s Diseases; 2023 Mar 28–Apr 1; Gothenburg, Sweden. Abstract.
Hendrix S, et al. Proof-of-concept study design leveraging digital biomarkers to enhance statistical power and reduce sample size in PD trials. Mov Disord. 2025;40 Suppl 1. Abstract. Available from: https://www.mdsabstracts.org/abstract/proof-of-concept-study-design-leveraging-digital-biomarkers-to-enhance-statistical-power-and-reduce-sample-size-in-pd-trials/
Fehlmann B, et al. Relationship of satisfaction and adherence in remote digital monitoring: updated results from a clinical drug trial in early Parkinson’s disease. Mov Disord. 2022;37 Suppl 2. Abstract. Available from: https://www.mdsabstracts.org/abstract/relationship-of-satisfaction-and-adherence-in-remote-digital-monitoring-updated-results-from-a-clinical-drug-trial-in-early-parkinsons-disease/
Fehlmann B, et al. Patient perspectives on symptoms and functional impacts to inform a digital health technology outcome measure for Parkinson’s disease. Poster presented at: MDS International Congress; 2023 Aug 27–31; Copenhagen, Denmark. Available from: https://medically.gene.com/global/en/unrestricted/neuroscience/MDS-2023/mds-2023-poster-fehlmann-patient-perspectives-on-sympto.html
Riese FM, et al. Using patient-reported quality of life outcomes to assess the validity of smartphone-based remote assessment of motor and cognitive performance in manifest Huntington’s disease patients. Poster presented at: MDS Virtual Congress; 2021 Sep 17–22; Online. https://www.mdsabstracts.org/abstract/using-patient-reported-quality-of-life-outcomes-to-assess-the-validity-of-smartphone-based-remote-assessment-of-motor-and-cognitive-performance-in-manifest-huntingtons-disease-patients
Neuron23. Neuron23 announces usage of Roche’s Digital Biomarker and device in Parkinson’s disease clinical trial [Internet; cited 2026 May 11]. Available from: https://neuron23.com/neuron23-announces-usage-of-roches-digital-biomarker-and-device-in-parkinsons-disease-clinical-trial/
The Michael J. Fox Foundation for Parkinson’s Research. The landmark Parkinson’s Progression Markers Initiative is now using a mobile app [Internet; cited 2026 May 11]. Available from: https://www.michaeljfox.org/ppmi-mobile-app

Disclaimer

Not every digital product is available in all markets. The use of any third-party app is subject to a separate license agreement with the respective third-party app developer. Roche gives no warranties (express or implied) with regard to any third-party app. Third-party apps might not be available in your country. This website and its content may be accessible worldwide, Roche assumes no liability with regard to the access to the information, which may not be compatible with legislations or regulations in force in your country.
*The navify Digital Biomarkers solution is intended to collect, store and process digital clinical data to support exploratory research in clinical trials. This solution is not meant to be used for diagnosis and treatment decision making for individual patients.

Digital biomarkers for clinical trials