looking after psychological outcomes

digital biomarkers for mental health therapeutics

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CNS & Psychiatry Clinical Trials Challenges

Pick the right patient population

Nonspecific factors can influence study outcomes:

Inclusion of non-informative patients for therapeutic indications
Inefficient capture of self assessed reports
Site and patient bias in any self assessment

Track & quantify changes

Standard instruments have psychometrics properties for which they don’t act as linear scales
Lack of objective, multi faceted, biomarkers coherence on the self assessed reports
Issues in medication seizing
Site and patient bias in any self assessment

85%

of CNS Clinical Trials
FAILS

>50%

Average Placebo Response

however,

signal can be distinguished from noise

it's all about decrypting signals

a multimodal approach to disease specific patterns

SENSEDAT uses a multimodal approach to detect different physiological & behavioral data related to the Autonomous Nervous System Response, which are transformed into disease specific information

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identifying clinical phenotypes from their physiological activation

your advantage?

better patient selection

enhanced data informativeness

reduced sample size & trial duration

take control over placebo response

what you get

Digital Diagnostic and Monitoring

mood and anxiety disorders symptoms

Applicable to clinical and non-clinical population

Early identification of at risk cases.

Predictive Outcomes

Prognostic estimates on disease severity

Cloud

+ proprietary algorithms
+ fully hosted on cloud
+ Cloud As A Service & Rest API

Data management & security

Cybersecurity

Complying with the FDA cybersecurity guidance across all the layers of the stack.

Continuously updating according to the changing cyber threat landscape

HIPAA & GDPR compliance

Encrypted PHI (Protected Health Information). Patient consent management - adults and adolescents, multi revision, multilingual, multi types. Audit logs - patient behaviour, caregiver access, device events. Compliant multi region data routing - supporting multiple cloud deployments and routing of device data.

Device & data collection management

Device and gateways management - pairing, mutual authentication certificates, remote configuration, events, alerts, log collection, and firmware updates (FOTA). Real-time and offline monitoring and analysis