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    CollabAI

    ClinicalAI by CollabAI — try the live pharma demo right now.

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    For Pharma, CROs & Life Sciences Companies
    ClinicalAI by CollabAIby CollabAI

    AI Agents Built for the Most Regulated Industry on Earth.

    ClinicalAI automates outbound patient follow-up, adverse event coding, and regulatory document review — built on a 21 CFR Part 11 compliant stack with full audit trail, e-signatures, and HIPAA-ready infrastructure.

    18+ pharma agentsPart of 100+ on Control Tower
    Book a Demo Try the Live Demo
    21 CFR Part 11HIPAA-readyGDPR compliantGCP / ICH E6 R2

    For CIOs, VP Clinical Operations & Head of Drug Safety

    Replace manual patient follow-up calls, automate MedDRA coding, and cut regulatory document review costs — without replacing your EDC, CTMS, or LIMS.

    Book demoTry live demo
    The reality

    You're losing hours to work software should handle.

    01

    Manual patient follow-up at scale

    Clinical trial coordinators spend days calling patients about missed visits. Each call takes 15+ minutes. At 500 patients, that's 125+ hours per cycle.

    02

    MedDRA coding backlogs

    Medical coders manually map patient-reported symptoms to MedDRA terms. One adverse event backlog can delay a study submission by weeks.

    03

    Regulatory review costs $2,000/hour

    Pharma companies pay legal teams to verify FDA submission documents against regulatory guidelines. AI does it in minutes — at 1% of the cost.

    Product Suite

    Purpose-built for pharma. Not adapted from something else.

    Every product in the PharmaAI suite is built from the ground up for regulated life sciences environments — 21 CFR Part 11, HIPAA, GCP, and ALCOA+ by default.

    FLAGSHIP PRODUCT
    Clinical Trials

    ClinicalAI

    Outbound AI voice calls to clinical trial patients. Protocol-driven interviews, adverse event capture, MedDRA coding, and a 21 CFR Part 11 compliant admin console.

    AI calls patients at scale — 500 interviews overnight
    Live call monitor with protocol tracker + AE detection
    MedDRA auto-coding with SMQ screening
    QC review queue with e-signature
    Immutable audit trail — HSM timestamped
    4 role-based logins for pharma teams
    21 CFR Part 11HIPAAGDPRALCOA+
    Try the Interactive Demo See product detail
    IN DEVELOPMENT
    Drug Safety

    Pharmacovigilance AI

    AI reviews incoming adverse event reports, auto-codes to MedDRA, flags severity levels, and routes to your safety officer with FDA MedWatch integration.

    ICH E2B(R3)MedDRA v27.xFDA MedWatch
    See Product Detail →
    IN DEVELOPMENT
    Regulatory Affairs

    Regulatory Doc Validator

    Upload any FDA submission or drug label — AI checks every section against current FDA/EMA guidelines, flags non-compliant language, and generates a correction report.

    FDAEMAICH
    See Product Detail →
    IN DEVELOPMENT
    Payer Operations

    AI IVR Navigator

    AI dials out and navigates payer IVR systems automatically. Your rep gets an alert the moment a human agent is available — eliminating hold time completely.

    DTMFSTIR/SHAKENHIPAA
    See Product Detail →

    All PharmaAI products are powered by the CollabAI platform — HIPAA-compliant infrastructure, role-based access, HSM audit trail, and white-label architecture.Learn about the platform →

    What changes

    The numbers, in production.

    • 98%
      Call completion rate
    • 2×
      Faster data collection
    • $47
      AI cost vs $312 manual per interview
    • 100%
      Calls QC-reviewed automatically
    Use cases

    Where teams put this to work.

    All use cases

    Automate clinical trial patient follow-up

    AI calls 500 patients overnight, captures health status, adverse events, and missed visit reasons with full consent.

    125+ coordinator hours saved per study cycle125+ hrs/cycle

    MedDRA coding with SMQ screening

    Patient verbatim responses auto-mapped to MedDRA PT/HLT/HLGT/SOC with pharmacovigilance signal detection.

    Coding backlogs eliminated. CDISC SDTM export ready.Same day

    Regulatory document review at AI speed

    Upload FDA submission or protocol — AI checks against current guidelines in minutes.

    Cut $40K per submission in legal review fees$40K saved
    Agents

    Specialized agents, built for this work.

    All agents
    Clinical Trials

    Patient Follow-Up Agent

    Outbound AI voice calls to clinical trial patients. Protocol-driven interview, consent capture, adverse event detection.

    Pharmacovigilance

    MedDRA Coding Agent

    Auto-proposes MedDRA PT, HLT, HLGT, SOC from verbatim patient responses. SMQ screening. CDISC SDTM export.

    Quality Control

    QC Review Agent

    Automated QC disposition on 100% of calls. PASS/FLAG/FAIL/ESCALATED. Triggers deviation workflow on FAIL.

    Compliance

    Audit Trail Agent

    Every action HSM-timestamped and immutable. RFC 3161. 15-year retention. 21 CFR Part 11 §11.10(e) compliant.

    Compliance

    E-Signature Agent

    Full e-signature manifest with countersignature workflows. Meaning-of-signature per record. 21 CFR Part 11 Subpart C.

    Regulatory Affairs

    Regulatory Document Validator

    Upload FDA submission or label text — AI checks against current guidelines, flags issues, suggests corrections.

    See how the agents combine into workflows
    The playbook

    How pharma go live.

    A phased rollout designed for regulated pharma environments. Phase 0 is UX demo. Phase 1 is working voice agent. Phase 2 is full production. Each phase includes documentation artifacts for Computer System Validation.

    1. Phase 0 (Now) · 01

      Interactive prototype

      • Full UX demo at clinicalai.aideveloper.consulting
      • 4 role-based logins (Director, Coder, QC, Coordinator)
      • All screens: call monitor, MedDRA coding, QC queue, audit trail
    2. Phase 1 (4 weeks) · 02

      Working voice agent

      • Real ElevenLabs agent configured for your protocol
      • Live outbound calls to test numbers
      • Transcript captured + MedDRA coding pipeline active
    3. Phase 2 (8-12 weeks) · 03

      Full production

      • HIPAA-compliant infrastructure
      • MedDRA v27.x coding engine (requires client license)
      • 21 CFR Part 11 audit trail
      • EDC integration (Medidata / Veeva)
    4. Phase 3 (ongoing) · 04

      Validation & compliance

      • IQ/OQ/PQ documentation
      • Requirements Traceability Matrix
      • System Validation Report
      • FDA inspection readiness
    125+/cycle
    Coordinator hours saved
    $40K/submission
    Legal review savings
    98%
    Call completion rate
    "We went from 500 manual calls per cycle to overnight AI completion. The audit trail is inspection-ready from day one."
    — Head of Clinical Operations, CRO
    Live demos

    See it running, right now.

    Two sandboxes for pharma. Click around, break things — no signup, no install.

    Try the live demo

    Log in as Study Director, Medical Coder, QC Reviewer, or Site Coordinator — instant access.

    clinicalai.collabai.software

    See the live call monitor

    See a clinical trial call in progress — transcript, protocol tracker, AE detection.

    clinicalai.collabai.software

    Works with your stack

    No rip-and-replace.

    Medidata RaveOracle ClinicalVeeva VaultREDCapElevenLabsTwilioMedDRA v27.xCDISC SDTMHL7 FHIRAzure (HIPAA)AWS GovCloud
    Proof

    Battle-tested, not beta.

    "We went from paying coordinators to make 500 calls per cycle to having the AI complete them overnight. The MedDRA coding is more consistent than our manual process and the audit trail is inspection-ready."
    Head of Clinical Operations
    Mid-size CRO
    125+ coordinator hours saved per cycle
    "The regulatory document validator alone justified the investment. We were spending $40K per submission on legal review. The AI catches the same issues in an afternoon."
    VP Regulatory Affairs
    Specialty Pharma
    $40K saved per submission
    Your data. Your control.
    21 CFR Part 11HIPAAGDPR Article 9GCP ICH E6 R2ICH E2B(R3)ALCOA+GAMP 5Audit trail on every action

    Frequently asked questions

    CollabAI Agents Marketplace

    More pharma agents in the Marketplace

    Browse the full catalog of agents from across our platform — install, remix, or submit your own.

    Browse the live catalog directly on the marketplace.

    Open Marketplace
    Browse all agents on the Marketplace
    The engine underneath

    Same engine. Tuned for 21 CFR Part 11, HIPAA, and GCP compliance.

    Every vertical surface above runs on the CollabAI Platform — a private agent runtime and a knowledge layer, deployed inside your tenant.

    Agent Runtime

    100+ agents · orchestration · audit log

    Knowledge + RAG

    Meetings · docs · CRM · semantic recall

    Private by design

    Self-hosted by default · your tenant, your keys

    See the CollabAI Platform

    See it working. Right now.

    One click. Real data. Real agents. No signup.

    Book a Demo Talk to sales
    21 CFR Part 11 readyHIPAA + GDPRWhite-label availableAudit trail on every action

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