Digital biomarkers and real-world evidence
RWE for clinical trials and observational studies. No therapeutic claims required.
Trial RWE Dashboard
Study MH-2024-CNS
Effect Size
0.72
p-value
<0.001
Adherence
94%
Digital Marker
Cognitive load: -23%
40+
Digital markers
FDA Ready
Documentation
-60%
Data collection cost
24/7
Passive monitoring
Clinical-grade digital endpoints
Digital Marker Extraction (RWE)
Extract structured psychological markers from patient-reported data.
Quality of Life Reports
Automated QoL assessments for clinical documentation.
PRO Report - Week 12
FDA submission ready
Responder Analysis
CGI-S correlation
Time to Response
Kaplan-Meier curves
EDC/eCOA Integration
# Digital marker extraction
response = mential.extract_markers(
patient_text=diary_entry,
study_id="MH-2024-CNS",
timepoint="week_12"
)
# Returns validated endpoints
{
"anxiety_score": 0.21,
"depression_score": 0.28,
"sleep_quality": 0.68,
"validated": true,
"confidence": 0.94
}HL7 FHIR Compatible
Seamless EDC integration
21 CFR Part 11
Audit trail & e-signatures
GxP Validated
IQ/OQ/PQ documentation
From trials to market
Digital Endpoints for Trials
Psychological digital endpoints for CNS and other therapeutic areas.
Adherence Programs
Non-pharmacological support programs that complement drug therapy.
Observational Studies
Real-world data collection for post-market studies and registries.
Psychological Comorbidity
Track psychological impact in chronic disease populations.
Ready to add digital endpoints?
See how Mential can provide RWE for your clinical programs.
