Advancing early-phase
trial design

Advancing early-phase
trial design

Advancing early-phase
trial design

Design smaller trials with greater confidence in
detecting treatment effects through precise,
high-frequency measurement

Design smaller trials with greater confidence in
detecting treatment effects through precise,
high-frequency measurement

More frequent measurement. Greater precision.

More frequent measurement. Greater precision.

More frequent measurement. Greater precision.

Smaller trials. Increased statistical power.

Smaller trials. Increased statistical power.

Smaller trials. Increased statistical power.

Higher signal-to-noise measurement can reduce the sample size needed to detect a treatment effect or increase statistical power at a given sample size

Higher signal-to-noise measurement can reduce the sample size needed to detect a treatment effect or increase statistical power at a given sample size

Higher signal-to-noise measurement can reduce the sample size needed to detect a treatment effect or increase statistical power at a given sample size

Explore the impact on trial design

Explore the impact on trial design

Explore the impact on trial design

Based on our work in Parkinson’s disease, explore the simulated impact of precise, high-frequency measurement on sample size and statistical power

Scientific partnership from trial design to analysis

Scientific partnership from trial design to analysis

Scientific partnership from trial design to analysis

We support sponsors from study protocol design through analysis and regulatory and scientific reporting, helping integrate precision measures into early-phase trials

We support sponsors from study protocol design through analysis and regulatory and scientific reporting, helping integrate precision measures into early-phase trials

Trial design

Trial design

Endpoint selection, assessment schedule, sample size and power calculations

Endpoint selection, assessment schedule, sample size and power calculations

Trial conduct

Trial conduct

Measure deployment, adherence monitoring, and quality control

Measure deployment, adherence monitoring, and quality control

Analysis and reporting

Analysis and reporting

Statistical analysis plans, interim and final analyses, reports and publications

Statistical analysis plans, interim and final analyses, reports and publications

Built for international clinical trials

Built for international clinical trials

Built for international clinical trials

Comprehensive motor and cognitive measurement

Comprehensive motor and cognitive measurement

Deployed in 30 countries and 14 languages

Deployed in 30 countries and 14 languages

Adherence and data quality monitoring

Adherence and data quality monitoring

Secure data transfer, processing, and analysis

Secure data transfer, processing, and analysis

The Scientific and Clinical Team

The Scientific and Clinical Team

The Scientific and Clinical Team

Emmanuel Bartholomé, MD

Emmanuel Bartholomé, MD

Head of Clinical Development

Head of Clinical Development

Neurologist and Rehabilitation Specialist, Medical Director of Digital Biomarker Clinical Strategy, Biogen Digital Health (2021-2023)

Head of Neurology Department (CHU Tivoli, BE) and MS Clinical Trial Investigator (2008-2021)

Neurologist and Rehabilitation Specialist, Medical Director of Digital Biomarker Clinical Strategy, Biogen Digital Health (2021-2023)

Head of Neurology Department (CHU Tivoli, BE) and MS Clinical Trial Investigator (2008-2021)

Corrado Bernasconi, MD PhD

Corrado Bernasconi, MD PhD

Head of Biostatistics

Head of Biostatistics

Statistician and Computational Neuroscientist Senior Biostatistician at F. Hoffmann-La Roche AG (2005-2023)

Co-Head of the Neuroscience Clinical Trial Unit, University of Bern (2014-2021)

Statistician and Computational Neuroscientist Senior Biostatistician at F. Hoffmann-La Roche AG (2005-2023)

Co-Head of the Neuroscience Clinical Trial Unit, University of Bern (2014-2021)

Claudia Mazzà, PhD

Claudia Mazzà, PhD

Head of Research

Head of Research

Professor of Biomechanics, The University of Sheffield (UK), Department of Mechanical Engineering (2019-Present) 

Executive Director of Insigneo Institute for in silico Medicine (Sheffield, 2019-2020) Work Package Leader of Mobilise-D

Professor of Biomechanics, The University of Sheffield (UK), Department of Mechanical Engineering (2019-Present) 

Executive Director of Insigneo Institute for in silico Medicine (Sheffield, 2019-2020) Work Package Leader of Mobilise-D

Óscar Gabriel Reyes Pupo, PhD

Óscar Gabriel Reyes Pupo, PhD

Head of Data Science & Signal Processing

Head of Data Science & Signal Processing

Assistant Professor of Computer Science and Artificial Intelligence at the University of Holguín, Cuba (2008–2016) 

Assistant Professor at The Maimonides Institute of Biomedical Research of Córdoba (IMIBIC, 2017-2020)

Assistant Professor of Computer Science and Artificial Intelligence at the University of Holguín, Cuba (2008–2016) 

Assistant Professor at The Maimonides Institute of Biomedical Research of Córdoba (IMIBIC, 2017-2020)