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
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
Fully hosted on 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
Technology Partners
Active Projects
Burnout Syndrome in Healthcare workers
Wearing-off prediction for Parkinson's disease
mental wellbeing sport professionals
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