Human Evidence

Turn voice and video into regulatory grade safety data in days

One pipeline converts patient speech and behavior into CDISC SDTM rows that regulators and sponsors can trust

Problem

The hardest signals in Psychiatry live in unstructured media

Trials capture thousands of hours of sessions. People do not have time to watch them. Scales miss what patients actually say and how they say it. Safety signals get coded late or not at all. Timelines slip. Budgets bloat. Submission risk grows.If your team still reviews sessions by hand, you burn months and money.

what we do

We structure human media into machine readable evidence

Human Evidence ingests recorded sessions from clinical programs and post marketing care. We convert every spoken sentence into traceable observations, events, and outcomes that map to CDISC SDTM with full lineage back to source audio or video.Results are fast, auditable, and ready for sponsor review.

What you get

Deliverables

Redacted and non redacted media archivesTranscripts and diarization filesSDTM packages with define files and annotationsReviewer console with lineage viewAccuracy and coverage reports for QA and audits

Time to value

Technical kickoff in one weekFirst structured output in two weeks on a pilot datasetProduction ramp within one quarter for a full program

How it works

Ingest

Secure upload or direct capture from your platformPHI aware ingestion with automatic redaction options

Structure

Mapping to SDTM domains such as AE, CM, MH, SU, QS where relevantSDTM annotations with controlled terminology


Understand

Speaker diarization and clinical grade transcriptionSentiment, affect, and symptom cues extracted at utterance level

Review

Human sign off by qualified reviewersPoint and click lineage from any row back to the exact moment in the source file


Code

Adverse events identified and coded to MedDRAConcomitant meds, interventions, and outcomes captured with timestamps

Export

SDTM packages and analysis ready tablesSponsor and CRO handoff without rework

Outcomes that matter

Fewer missed or late AEsFewer queries and reconciliation loopsFaster database lockClearer narratives for reviewers and payersLower total cost of data

Why we are different

Why we are different

  1. Speed without shortcuts
    Hours, not quarters, to see first structured outputs on your own data

  1. Built for Psychiatry and CNS
    Tuned on complex conversations, not scripted call center audio

  1. Traceability by default
    Every field links back to the original utterance and timecode

  1. Human in charge
    AI assisted, clinician verified. You decide what goes into the database.

See your own data structured in two weeks

Book a 30 minute briefing

Thank you

Clinical media in. FDA submission data out.