We transform any smartphone into a measurement laboratory for precision medicine development

The Opportunity to Enhance Precision in Neurology

Clinical scales

YESTERDAY

Subjective

Imprecise

In-clinic

Infrequent

Conventional data points — in clinic visits

Digital endpoints

TODAY

Objective

More Accurate & Functional

In-clinic + Home + Ecological

Higher Sampling Frequency

Tech-enabled data points — in daily life

JAN

FEB

MAR

APR

MAY

JUN

JUL

AUG

SEP

OCT

NOV

DEC

A digital endpoint can reduce sample size and/or augment probability of success (PoS) of R&D proof-of-concept (PoC) trials through two strategies:

Use a digital measurement with higher Signal-to-Noise Ratio (SNR) as a decision-enabling proof-of-concept (PoC) trial endpoint.

Does not have to be fully convergent with reference measurement, while enhancing the end of Phase II decision trees to optimise probability of success (PoS) in Phase III.

Use higher longitudinal frequency of digital measurements that correlate with the reference measurement

These digital markers can then help “explain” the variation, reduce the noise, and increase the SNR for the reference measurement.

Through our multi-year strategic collaboration with Biogen, we aim to expand the reach of our unique technology into Parkinson’s disease, a critical disease area where innovation is crucially needed.

The extension of our work into Parkinson’s disease may cross-fertilize with the progress of our scientific efforts in Multiple Sclerosis.

Indivi's focus on digital endpoint development spans across key neurodegenerative disorders, including Alzheimer’s disease, and related dementias.

The Scientific and Clinical Team

An intersection of knowledges and experiences.

Óscar Gabriel Reyes Pupo, PhD

Head of Data Science & Signal Processing

Assistant Professor of Computer Science and Artificial Intelligence at University of Holguín, Spain (2008-2016)
Assistant Professor at The Maimonides Institute of Biomedical Research of Córdoba (IMIBIC, 2017-2020)

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Óscar Gabriel Reyes Pupo, PhD

Head of Data Science & Signal Processing

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Óscar Gabriel Reyes Pupo, PhD

Head of Data Science & Signal Processing

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Claudia Mazzà, PhD

Head of Research

Visiting Professor at The University of Sheffield, UK (Professor of Biomechanics until 2022)
Executive Director of Insigneo Institute for in silico Medicine (Sheffield, 2019-2020)
Work Package Leader of Mobilise-D

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Claudia Mazzà, PhD

Head of Research

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Claudia Mazzà, PhD

Head of Research

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Emmanuel Bartholomé, MD

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)

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Emmanuel Bartholomé, MD

Head of Clinical Development

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Emmanuel Bartholomé, MD

Head of Clinical Development

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Corrado Bernasconi, MD PhD

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)

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Corrado Bernasconi, MD PhD

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)

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Corrado Bernasconi, MD PhD

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)

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Ella Gibbs

Clinical Operations & Program Lead

Clin Ops Project Manager at Roche (2020-2023)
Researcher at Imperial College London (2017-2020)

Ella Gibbs

Clinical Operations & Program Lead

Clin Ops Project Manager at Roche (2020-2023)
Researcher at Imperial College London (2017-2020)

Ella Gibbs

Clinical Operations & Program Lead

Clin Ops Project Manager at Roche (2020-2023)
Researcher at Imperial College London (2017-2020)

A Unique Quality Control Embedded in the Data Science Pipeline

In remote unsupervised settings of sensor data collection, precision is about quality, quality, and quality.

Raw signal input

Raw data input

Event data

Sensor data

Raw data input

Event data

Sensor data

Raw data input

Event data

Sensor data

Signal verification preprocessing pipeline

Device information checks

Event data standard format checks

Sensor data standard format checks

Signal verification preprocessing pipeline

Device information checks

Event data standard format checks

Sensor data standard format checks

Signal verification preprocessing pipeline

Device information checks

Event data standard format checks

Sensor data standard format checks

Test execution correctness quantification

Human activity recognition (HAR) algorithms

Machine learning supervised models

Test execution correctness quantification

Human activity recognition (HAR) algorithms

Machine learning supervised models

Test execution correctness quantification

Human activity recognition (HAR) algorithms

Machine learning supervised models

Feature extraction pipeline

Embedded data quality checks

Specific library of features for each of the 25 instruments

Trained across a wide variety of smartphone hardware systems

Feature extraction pipeline

Embedded data quality checks

Specific library of features for each of the 25 instruments

Trained across a wide variety of smartphone hardware systems

Feature extraction pipeline

Embedded data quality checks

Specific library of features for each of the 25 instruments

Trained across a wide variety of smartphone hardware systems

Output

Computed digital measures
Statistical analyses
Client specific data formats

Output

Computed digital measures
Statistical analyses
Client specific data formats

Output

Computed digital measures
Statistical analyses
Client specific data formats

Ground Truth Reference Adjustment of the Feature Extraction Pipeline

All our measurements are technically validated across a wide variety of smartphone hardware in our in-house ground truth laboratory

End-to-End digital endpoint development technology for RCTs

Indivi provides comprehensive services throughout clinical trials, from protocol design to regulatory and scientific reporting, aimed at developing innovative digital endpoints tailored to the disease and context of use

Protocol preparation

Schedule of assessments, sample size & power calculation, innovative designs

Clinical trial

Adaptive interim analyses, responsive digital measure identification

Analysis phase

SAP preparation, final & post-hoc statistical analysis

Indivi's capabilities enable international deployment, comprehensive neurological measurement of neurological functions and compliant, high-quality data collection, storage, analysis and monitoring

Movement

Cognition

Vision

Balance

Dexterity

Voice

Comprehensive neurological
function coverage

France

👋 Bonjour

English

👋 Hello

Spanish

👋 Hola

Deployment capabilities in 30 countries and 26 languages

Adherence, data quality and test execution correctness monitoring

Regulatory compliant data transfer,
processing and analysis

Pioneering the future of precision neurology

Indivi and RC2NB are dedicated to unlocking the immense potential of digital measurements in drug development.

Indivi’s close research cooperation with the teams at RC2NB (Co-CEOs Profs. Cristina Granziera and Ludwig Kappos) creates a unique intersection between expert knowledge in Software Development, Data Science, Clinical Science and Advanced Analytics (including Machine Learning and Artificial Intelligence).

The Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) is an internationally renowned institution embedded in Basel University Hospital and University of Basel.
RC2NB specialises in the development and integration of innovative tools that comprehensively characterise the disease process, thus facilitating the development of better treatments and enabling personalised disease management for people affected by MS and other neuroimmune and neurodegenerative diseases.

More about RC2NB

Pioneering the future of precision neurology

More about RC2NB

Pioneering the future of precision neurology

More about RC2NB