NIH NIDA SBIR Phase I  ·  1R43DA062307-01

The AI-native DCT platform for
behavioral health trials

Trialli is the first decentralized clinical trial platform purpose-built for substance use disorder research. AI conducts clinical interviews, coordinates participants, and monitors your trial — so coordinators focus on science.

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0 SUD-specific
competitors
$18.8B DCT market
by 2030
25–70% SUD trial
dropout rate
NIH NIDA SBIR
funded
Trialli Admin Portal
Trialli Patient App
The Problem

SUD trials fail at retention —
because existing tools weren't built for this population

Every existing DCT platform was designed for oncology and pharmacology trials in non-stigmatized conditions. None of them understands SUD.

25–70%

Dropout rate

SUD trial dropout is the #1 cost driver. Housing instability, stigma, and variable shift work mean participants cannot keep clinic appointments — and existing platforms assume they can.

$50–100K

Per coordinator per year

Study coordinators spend most of their time on structured check-ins, form administration, and protocol reminders — tasks that AI can handle at a fraction of the cost.

+40 days

Retention from clinician referral

Systematic coordinator contact adds 40 days of retention. AI can scale that contact to every participant, every week — without adding headcount.

REDCap

The status quo

The NIDA Clinical Trials Network — 16 nodes, hundreds of SUD trials — runs on REDCap. No mobile app. No AI. No voice. Trialli is the purpose-built replacement.

Differentiation

Three capabilities no other
DCT platform has

01

AI conducts clinical interviews

The AI administers validated instruments — ISI, BAM, PROMIS, AUDIT, TLFB — via voice conversation with the participant. Structured scores are extracted automatically and stored in the EDC with confidence flags. No other platform does this.

Voice Assessment
02

Purpose-built for SUD & behavioral health

Pre-configured SUD instruments (ASI, AUDIT, COWS, CIWA, Penn Craving Scale, Columbia Suicide Severity Rating Scale). Community-based site model for treatment centers, MAT clinics, and residential programs. Dropout-prevention design throughout.

SUD Vertical
03

AI coordinator, not just AI-assisted

An agentic AI system handles the full participant relationship: scheduled check-ins, missed visit detection, protocol reminders, safety screening with C-SSRS criteria, and escalation to human coordinators. Available 24/7. Scales to any trial size.

Agentic AI
Competitive Landscape

How Trialli compares

Platform SUD Focus Voice AI Assessment Patient-Facing AI Community Site Model Pricing
Trialli You are here ✓ Purpose-built ✓ Full interview ✓ AI Coordinator ✓ Native Per-participant SaaS
Medidata Rave ✗ ✗ ✗ ✗ $200K–$2M/study
Medable ✗ ✗ Investigator only ✗ $150K+/study
Castor EDC ✗ ✗ ✗ ✗ Custom
REDCap ✗ ✗ ✗ ✗ Free / self-hosted
ObvioHealth ✗ ✗ ✗ ✗ Custom

Source: Competitive analysis conducted March 2026. No major DCT platform has SUD-specific positioning, instruments, or voice AI capability.

Category-Defining Feature

AI-administered clinical interviews.
A capability that doesn't exist anywhere else.

Instead of a coordinator calling each participant to manually administer the ISI or BAM, the AI conducts the interview via voice — and pushes structured, confidence-scored data directly into the EDC.

📱

Participant taps "Check-in"

Available 24/7 on mobile. No appointment. No commute. No missed visit.

→
🎙️

AI conducts the interview

Asks ISI, BAM, or PROMIS questions conversationally. Adapts to unclear responses. Generates clarifying follow-ups.

→
📊

Scores extracted automatically

Structured output with per-item scores, confidence levels, and full transcript. Low-confidence items flagged for coordinator review.

→
🔒

Into the EDC with audit trail

DataRecord stored as AI_ADMINISTERED. Full transcript linked. 21 CFR Part 11 compliant.

Supported instruments

Insomnia Severity Index (ISI) Brief Addiction Monitor (BAM) PROMIS-SUD Modules AUDIT / AUDIT-C Timeline Followback (TLFB) Columbia SSRS ASI (planned) COWS / CIWA (planned) PHQ-9 / GAD-7 PCL-5
🛡️

Built-in safety screening

Every participant response is screened in parallel using Columbia Suicide Severity Rating Scale criteria. If distress or suicidality signals are detected, the assessment pauses immediately, crisis resources appear, and the coordinator receives an escalation alert. This runs on every turn, automatically.

Workflow

From IRB to data lock —
every step supported

01

Sponsor creates trial & invites team

Draft protocol, configure sites (treatment centers, MAT clinics, residential programs), assign site PIs and coordinators, invite IRB reviewers — all by email. New users get automatic account setup.

02

IRB approves in-app

Reviewers log in, read the protocol, and approve or reject with comments. No DocuSign. No email threads. Only approved trials can activate enrollment.

03

Coordinators enroll participants

Send invitations by email. Participants receive a link to the Trialli app, create an account, and see their invitation. No app store account required for web.

04

Digital informed consent

Participants review the full consent document, agree to terms, and sign electronically — drawn or typed signature. Consent status updates in real time for coordinators.

05

AI conducts check-ins & assessments

The AI coordinator schedules and conducts voice check-ins (ISI, BAM, PROMIS), sends reminders, detects missed visits, and escalates safety signals — all without coordinator involvement by default.

06

Coordinators monitor & manage exceptions

Review AI-generated assessments, manage flagged items, report adverse events, track compliance — spending time on clinical judgment, not administrative contact.

The Platform

Built for every stakeholder

Sponsor & Coordinator Portal

A full-featured web application for sponsor administrators and site coordinators. Manage trials, review AI-generated assessments, track compliance, report adverse events — from a single dashboard.

  • Role-based access: Sponsor Admin, Site PI, Coordinator, IRB Reviewer
  • Real-time participant enrollment, consent, and compliance status
  • AI assessment review queue with transcript + confidence scores
  • Audit log for all critical actions (21 CFR Part 11 aligned)
  • Adverse event reporting with SAE escalation workflow
Trialli Admin Portal

Participant Mobile App

A consumer-grade mobile experience — iOS, Android, and web — designed for the realities of SUD populations: low digital literacy, variable schedules, housing instability.

  • Digital consent with e-signature (drawn or typed)
  • Scheduled forms with overdue tracking and reminders
  • Voice check-in: speak naturally, AI handles the rest
  • Document and image upload from camera or phone storage
  • AI assistant for trial questions (privacy-first, self-hosted LLM)
Trialli Patient App

Privacy-First AI Assistant

Participants get instant, accurate answers to their questions about the trial. The AI runs on a self-hosted GPU server with retrieval-augmented generation over the trial protocol and SUD literature — no participant data ever leaves your infrastructure.

  • RAG-grounded on trial protocol, consent form, and SUD literature
  • Source citations shown for every response
  • Voice input via Whisper speech-to-text
  • HIPAA-aligned: self-hosted on dedicated GPU server
Trialli AI Assistant

Wearable & Device Data

Collect continuous or episodic health data from participants using consumer wearables or manual entry. Sleep and actigraphy data map directly to BBTI and insomnia trial outcomes.

  • Heart rate, blood pressure, sleep, weight, SpO₂
  • Empatica Embrace2 integration (validated in SUD research)
  • Manual entry with pending/sync status tracking
  • History view with date-organized records
Trialli Wearable Data
Full Feature Set

Everything a behavioral health trial needs,
built in from day one

AI Voice Assessment Administration

The AI administers structured clinical instruments via natural voice conversation. Participants speak their answers; AI extracts scores, detects ambiguity, asks clarifying follow-ups, and returns structured data to the EDC. Every session is transcribed, scored, and linked to the participant's audit trail.

  • ISI, BAM, PROMIS, AUDIT, TLFB, Columbia SSRS and more
  • Confidence scoring via logprob-calibrated extraction
  • Parallel C-SSRS safety screen on every response
  • Low-confidence sessions flagged for coordinator review

Trial Lifecycle Management

DRAFT → PENDING → APPROVED → ACTIVE with full audit trail. Multi-site with per-site personnel, IRB approver assignment, sponsor + coordinator role hierarchy.

Digital Informed Consent

Participants review, agree, and sign electronically — drawn or typed signatures — right from their phone. Consent status tracked in real time for coordinators.

Safety & Adverse Events

Structured AE reporting with severity classification and SAE escalation. Built-in C-SSRS safety screen during every AI check-in. ICH E6(R2) GCP-aligned.

Participant Mobile App

iOS, Android, and web. Designed for SUD populations: simple interface, voice-first check-ins, offline form support, and crisis resources always one tap away.

Agentic AI Coordinator

A multi-agent backend that handles the participant relationship autonomously: scheduled assessments, missed visit follow-up, protocol compliance monitoring, and safety escalation routing. Human coordinators review exceptions; AI handles the routine.

  • Assessment Agent — administers voice instruments per protocol schedule
  • Follow-Up Agent — detects missed visits, sends check-in prompts
  • Compliance Agent — monitors data completeness, flags deviations
  • Safety Agent — C-SSRS screening on free text, routes to human reviewer

Structured eCOA & Forms

Configure validated forms (rating scales, single/multi-choice, free text, numeric) with per-form scheduling, overdue tracking, and revision workflows.

Audit Log & Compliance

Tamper-evident audit log on all critical models. 21 CFR Part 11 electronic signature support. Full trail for AI decisions, coordinator overrides, and data edits.

Architecture

Built to comply. Built to scale.

🤖

HIPAA-aligned LLM

Claude / GPT-4o via HIPAA BAA as primary. Llama-3-Meditron-70B on-premise for air-gapped deployments. RAG-grounded on trial protocol and SUD literature.

🎙️

Medical Speech-to-Text

gpt-4o-transcribe for Phase I (emulated). AWS Transcribe Medical for Phase II (real participants) — definitively HIPAA-eligible, covered under AWS BAA.

⚡

Django REST Framework

Battle-tested Python backend with role-based permissions, full audit logging, and structured output extraction using OpenAI strict JSON mode.

🌐

Angular 18 Admin Portal

Standalone-component admin portal with Material Design — fast, type-safe, accessible. AOT-compiled for production.

📱

Flutter (iOS / Android / Web)

Single codebase across platforms. Native performance. Designed for low-bandwidth and variable connectivity common in SUD participant populations.

🔒

Privacy-First Infrastructure

Railway today (staging + production). AWS migration for PHI-scale with SOC 2 / HITRUST path. Self-hosted GPU for institutions requiring on-premise AI.

Our Team

Clinical researchers.
Software engineers.
Mission-driven.

Trialli is built by a multidisciplinary team at the intersection of addiction medicine, clinical trial operations, and AI engineering — with NIH NIDA funding and Johns Hopkins University collaboration.

NIH Award
1R43DA062307-01
FOA
RFA-DA-25-052 (DCT for SUD)
Collaborating Institution
Johns Hopkins University
Trial Partner
Helping Up Mission, Baltimore
XF

Xuefeng Feng, PhD

Principal Investigator & Lead Engineer
Carina Medical LLC

Placeholder — add bio and institution here.

DA

Denis G. Antoine, MD

Co-Investigator
Johns Hopkins University

Placeholder — add bio and institution here.

+

Team Member

Role / Institution

Edit marketing/website/index.html — Team section to add members.

Get Started

The SUD trial platform
you've been waiting for.

We're actively piloting with NIDA-funded trials and NIDA CTN-affiliated sites. Request a demo and we'll walk you through the full workflow — voice assessment, AI coordinator, and all.

hello@trialli.io
Baltimore, MD / Remote
NIH Award 1R43DA062307-01

Request a Demo

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