Legit.Health · Clinical Trials Platform
Discovery Roadmap
A step-by-step framework to define the solution scope, confirm TBC items, and produce the project summary. Work through Steps 01–05 with your sponsor or CRO to lock every parameter before contract.
Define Condition & AI Scoring
Identify what disease area the trial addresses and which AI scoring system will generate the endpoint.
Discovery Questions
- ?What is the primary dermatological condition?
- ?Which AI scoring system is required by protocol?
- ?Is severity assessment a primary or secondary endpoint?
- ?Will the scoring system need regulatory validation documentation?
Psoriasis
APASIValidated. Peer-reviewed publication available.
Alopecia / Hair Loss
ASALT4-quadrant scalp. Adverse effect monitoring supported.
Acne
ALADIN2-perspective facial. IGA-aligned 0–4 scale.
Atopic Dermatitis
ASCORADTBC — confirm scope with Legit.Health.
Wounds
AWOSITBC — confirm scope with Legit.Health.
Output: Scoring system confirmed → drives image perspectives, report format, and endpoint documentation.
Define Image Capture
Determine how images will be collected, from where, and what AI validation will run at capture time.
Discovery Questions
- ?Will subjects capture from home (decentralized) or at the clinic (in-clinic)?
- ?How many perspectives per visit? How many full-body vs close-up?
- ?Is Automatic Image Quality Control required?
- ?Is Automatic Pose / Positioning Control (pose detection overlays) required?
Decentralized (from home)
✓ IncludedSubjects use clinicaltrials.legit.health on mobile. Guided perspective overlays.
In-clinic (site staff uploads)
✓ IncludedStaff captures at clinic visit. Same quality control applies.
Image Quality Control
✓ IncludedAutomatic clarity, lighting, and exposure validation. Always included.
Pose / Positioning Control
Available upon requestOverlay templates guide subjects to reproduce standardized positions. Confirm if needed.
Output: Capture mode + perspectives confirmed → drives Uploader config, perspective count, and subject instructions.
Define Study Parameters
Scope the operational dimensions of the study so the platform and pricing can be configured accurately.
Discovery Questions
- ?What is the Study ID?
- ?What is the desired start date (FPI)?
- ?What is the total study duration and the assessment period?
- ?How many sites, countries, and patients are expected?
- ?How many visits per patient, and how many images per visit?
- ?Is a study extension phase planned?
Study ID
TBD — provided by sponsor/CRO at contract
Desired Start Date
TBD — FPI date drives platform readiness deadline
Study Duration
TBD months total · TBD months assessment period
Number of Sites
TBD sites
Countries & Locales
TBD countries · Up to 14 language locales supported
Patients
TBD patients enrolled
Images per Visit
TBD total (TBD full-body + TBD close-up)
Visits per Patient
TBD visits · Visit window: ±TBD days each
Study Extension
TBC — confirm whether protocol includes extension phase
Output: Parameters locked → used to size Data Transfer schedule, diagnostic report count, and investigator manual scope.
Choose Platform Components
Confirm which modules from the Legit.Health platform are in scope. Items marked TBC need sponsor/CRO decision.
WebApp Clinical Trial Platform
✓ IncludedCore platform. Always included. Subjects + site staff access.
Severity Assessment (AI Scoring)
Available upon requestConfirm scoring system from Step 01. Drives diagnostic reports.
Automatic Image Quality Control
✓ IncludedAlways included. Real-time validation at upload.
Automatic Pose / Positioning Control
Available upon requestOverlay templates guide subjects to reproduce standardized positions.
Dashboard for CRO / Sponsor
Available upon requestLooker Studio. Real-time site metrics, enrollment, compliance. Password-protected.
Deviation Notifications
Available upon requestDaily digest emails to site admins for missed/late timepoints.
Monthly Data Transfers (DTA)
✓ IncludedAnonymized image exports. Background blur + facial redaction. HIPAA-compliant.
Final Data Transfer
Available upon requestEnd-of-study export. Confirm timing and format with sponsor.
Investigator Manual
✓ IncludedMultilingual Docusaurus manual at investigator-manual-[trial].legit.health. 14 locales.
Recorded Trainings
Available upon requestNumber and format TBC with sponsor. Typically 1–2 sessions.
Imported Timepoints
Available upon requestProtocol visit schedule imported into platform. Required for deviation tracking.
Anonymization Pipeline
Available upon requestAlways included with DTA. Background blur + facial redaction on all exported images.
Output: Scope confirmed → feeds directly into project summary, SOW, and platform configuration.
Review Project Summary
Once Steps 01–04 are answered, a project summary can be produced. Use this template as a checklist.
Project Overview
Platform Components
Deliverables
Ready to Fill in the TBCs?
Share this roadmap with your sponsor or CRO. Once all steps are answered, Legit.Health will produce a final Project Summary and SOW.