BeaconCR Intelligence Layer
Turn Patient and Caregiver Reports into Structured Real-World Evidence
BeaconCR Intelligence Layer helps research teams capture longitudinal patient-reported and caregiver-reported outcomes, score symptom burden across clinical domains, detect cross-domain research patterns, and export structured data for observational registries, compassionate-use programs, and sponsor-facing RWE reports.
Instrument Development Framework
Mission
To create structured research instruments that capture patient, caregiver, and clinician observations in a way that can support observational studies, compassionate-use programs, longitudinal registries, and real-world evidence generation.
Hypothesis
Longitudinal patient-reported and caregiver-reported symptom patterns can help research teams identify treatment-response signals, functional trajectories, safety observations, and quality-of-life changes across neurological injury and neuroinflammatory populations.
Intended Use
CARE-NFL-PRO-v2.0 is intended for research data collection, observational registry tracking, compassionate-use follow-up, and exploratory real-world evidence analysis. It is not intended for diagnosis, treatment selection, emergency triage, or clinical decision-making.
Current Development Status
Draft research instrument. Version 2.0. Demo mode. Not yet validated. Designed for stakeholder review, cognitive testing, caregiver feedback, clinician advisory review, and future psychometric validation.
Concept Framework
BeaconCR maps individual symptom responses into clinical research domains. Domain averages are converted into severity bands, ranked by burden, analyzed for cross-domain patterns, and exported into structured research data for longitudinal follow-up and sponsor-facing reports.
The 8 CARE-NFL-PRO-v2.0 Domains
Cognition
Memory, attention, processing speed, and executive function as reported by the patient or caregiver.
Examples
Short-term memory lapses · Difficulty concentrating · Slowed thinking · Word-finding difficulty
Neurological Symptoms
Sensorimotor and neurological symptom burden including headache, dizziness, and motor control.
Examples
Headache · Dizziness / balance · Tremor or spasticity · Numbness or tingling
Sleep
Sleep onset, maintenance, quality, and daytime impact.
Examples
Trouble falling asleep · Night waking · Unrefreshing sleep · Daytime sleepiness
Mood / Emotional Health
Emotional wellbeing, anxiety, low mood, and irritability.
Examples
Low mood · Anxiety · Irritability · Emotional lability
Functional Status
Activities of daily living, mobility, and independence.
Examples
Dressing / bathing · Mobility · Household tasks · Need for assistance
Quality of Life
Overall wellbeing, participation, and satisfaction with daily life.
Examples
Participation in activities · Social engagement · Overall wellbeing · Life satisfaction
Caregiver Observations
Changes observed by a caregiver, including burden and observed function.
Examples
Observed confusion · Observed mood change · Care demands · Caregiver strain
Treatment Response
Perceived response to current therapy and tolerability (research observation only).
Examples
Perceived benefit · Tolerability · Symptom change since last visit · Side-effect burden
Instrument Governance
Version History
Every instrument version is documented with date, rationale, question changes, scoring changes, and reviewer notes.
Question Suggestion Portal
Patients, caregivers, clinicians, and research advisors may suggest new questions or flag unclear wording for future review.
Instrument Change Log
All revisions are tracked to preserve research integrity, auditability, and version-specific interpretation of longitudinal data.
Research Advisory Board
BeaconCR may maintain a research advisory group of clinicians, caregivers, patients, statisticians, regulatory advisors, and disease-area experts to review instrument development.
Validation Roadmap
The BeaconCR Intelligence Layer is currently a research workflow prototype. Before use as a validated outcome instrument, BeaconCR should complete a staged validation pathway.
- 1
Stage 1 — Concept Elicitation
Collect input from patients, caregivers, clinicians, and disease-area experts to confirm that the instrument captures meaningful symptoms and functional changes.
- 2
Stage 2 — Cognitive Interviews
Test whether respondents understand the questions, response scales, recall periods, and domain wording as intended.
- 3
Stage 3 — Content Validity Review
Document whether the selected domains and questions adequately reflect the lived experience of the target population.
- 4
Stage 4 — Pilot Registry Deployment
Use the instrument in a limited observational registry or demo cohort to evaluate completion rates, missing data, usability, and caregiver burden.
- 5
Stage 5 — Psychometric Evaluation
Assess reliability, internal consistency, construct validity, known-groups validity, responsiveness to change, and minimally important difference estimates.
- 6
Stage 6 — Longitudinal RWE Integration
Integrate validated or fit-for-purpose measures into BeaconCR registry workflows, sponsor reports, and publication-ready datasets.
BeaconCR Intelligence Layer is an exploratory research workflow and draft PRO/ObsRO analytics prototype. It is not currently a validated clinical outcome assessment, not intended to support labeling claims, and not intended to replace validated disease-specific instruments. Any use in regulated research, product development, or labeling-supportive studies requires appropriate protocol design, IRB review, statistical analysis planning, and clinical outcome assessment validation strategy.
AI-assisted summaries are generated from structured response data and are intended only as research drafting aids. They must be reviewed by qualified study personnel before use in research reports, sponsor communications, regulatory summaries, or clinical documentation.
Designed for Intranasal CNS Research Workflows
BeaconCR Intelligence Layer can support observational follow-up for intranasal CNS programs, including neurological injury, neuroinflammation, TBI, post-concussion symptoms, HIE, cerebral palsy, and neurodegenerative research pathways.
For Kurve-related programs, the Intelligence Layer may help structure baseline and follow-up symptom reporting, caregiver observations, treatment-response narratives, safety observations, and longitudinal RWE summaries.
BeaconCR does not claim that any investigational therapy, device, biologic, exosome product, cell therapy, or intranasal intervention is safe or effective unless supported by appropriate clinical evidence and regulatory authorization.
Why This Matters
Many innovative physicians, caregivers, and sponsors observe meaningful patient changes that are never captured in a structured way. BeaconCR Intelligence Layer helps convert those observations into research-grade longitudinal data, allowing teams to track symptom burden, functional change, quality-of-life impact, caregiver observations, and treatment-response signals over time.
For Physicians
Add structured outcomes tracking to physician-led registries without building research infrastructure from scratch.
For Sponsors
Support real-world evidence generation with consistent PRO capture, structured exports, and longitudinal summaries.
For Patients and Caregivers
Give patient and caregiver observations a structured pathway into research data while preserving appropriate medical and ethical oversight.