* Revenue figures are market-based estimates only and are not guarantees of income. Actual results will vary based on execution, market conditions, and individual effort. This is not financial or investment advice.
How the agent runs it
AutoCohort operates as a white-label patient recruitment and cohort management bureau hired by Contract Research Organizations (CROs) and sponsor pharma companies. The agent team ingests trial protocols, autonomously builds and deploys multi-channel recruitment campaigns, screens inbound candidates against inclusion/exclusion criteria via structured intake interviews, manages visit scheduling and retention communications, and delivers real-time enrollment dashboards to site coordinators. The CEO orchestrator manages SLA compliance across all active trials simultaneously, re-routing capacity across the agent team as enrollment velocity changes.
Who this is for
The ideal owner has a background in clinical operations, CRO project management, or life sciences consulting — someone who already understands protocol design, IRB workflows, and what site coordinators actually need. They do not need to be an engineer, but they must be able to read a trial protocol and speak fluently with medical directors. This suits a former CRO director or clinical trial manager who wants to productize their domain expertise without hiring a full coordinator staff.
Market opportunity
The global clinical trial recruitment market is valued at over $4.5 billion and growing at 8% CAGR, driven by an explosion in rare disease trials, oncology pipelines, and post-COVID decentralized trial mandates. CROs are chronically under-resourced on patient recruitment — the #1 cause of trial delays — and are actively contracting out this function. The emergence of structured AI agent tooling in 2024–2025 is the first moment it has been technically feasible to automate screener interviews, eligibility logic, and retention cadences at clinical-grade reliability.
Boss agent: AXIS — Trial Operations Orchestrator
AXIS monitors SLA compliance across all concurrent trial arms, allocates agent capacity based on enrollment velocity targets, escalates anomalies to human review, and enforces protocol-specific business rules so no agent action violates the trial's IRB-approved procedures.
- ■ No patient communication may be sent without matching the exact IRB-approved consent language on file for that protocol version
- ■ Any screener response flagged as a potential serious adverse event triggers immediate human escalation and agent activity freeze on that participant record
- ■ Enrollment velocity reports must be delivered to the CRO dashboard within 4 hours of any site visit completion, with zero manual intervention required
The agent team
Human touchpoints
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- 👤 Signing master service agreements and CRO contracts — requires wet or DocuSign signature from the human owner as the legally accountable entity
- 👤 Reviewing and countersigning any IRB protocol amendment before AXIS deploys updated screening logic to INTAKE or HERALD
- 👤 Authorizing ACH disbursements above $25,000 and all new banking relationship setups
- 👤 Final approval on any participant record escalated by SENTINEL as a potential serious adverse event or protocol deviation before site notification
- 👤 Genuine regulatory crisis response — if FDA or an IRB issues a clinical hold or audit notice, the human owner must personally lead the response with qualified legal counsel
Tech stack
Monetization
AutoCohort charges CROs a per-protocol retainer of $18K–$35K/month per active trial arm, plus a $150–$400 per-qualified-screened-patient success fee. A single mid-size CRO running four concurrent Phase II trials represents $90K–$140K/month in recurring contract value.
Key risks
- → IRB and 21 CFR Part 11 compliance gaps: any patient-facing communication or data capture touching a clinical trial falls under FDA regulation — a single non-compliant outreach message could invalidate a trial arm and expose the CRO to regulatory action.
- → Patient privacy liability under HIPAA: the system processes PHI at scale, and a data breach or inadvertent disclosure in an agent-generated message creates federal liability that standard SaaS indemnity clauses cannot absorb.
Getting started
- 1 Obtain a master IRB services agreement templatePartner with a central IRB (e.g., Advarra or WCG) to establish a blanket agreement that covers patient-facing communications generated by your agent team. This is non-negotiable before any outreach touches a human subject.
- 2 Build a HIPAA-compliant data enclaveDeploy a BAA-covered cloud environment (AWS GovCloud or Azure Healthcare APIs) and configure REDCap as the structured data layer for all screener responses and patient records before writing a single agent prompt.
- 3 Sign one pilot CRO as a design partnerApproach a mid-tier CRO with a currently under-enrolled trial and offer a 90-day pilot at cost in exchange for protocol access, site coordinator feedback, and a case study. This gives you real data to calibrate inclusion/exclusion screening logic.
- 4 Codify five core protocol archetypes as agent templatesMost Phase II–III trials fall into oncology, metabolic disease, CNS, cardiovascular, or rare disease categories — build one validated screener interview flow and eligibility decision tree per archetype so new trial onboarding takes hours, not weeks.
- 5 Establish a site coordinator escalation SLA and pricing pageDefine exactly which outputs (pre-screened candidate packets, scheduling confirmations, dropout alerts) get delivered to human site coordinators and at what latency — then publish a transparent pricing page so CRO procurement teams can self-serve a quote without a sales call.
// done for you
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