Every patient recruitment vendor now claims AI. Most of what they call AI is automated messaging with a better marketing budget. Before signing a contract, run every vendor through these 12 questions. The answers tell you whether the tool solves your problem or creates a new one.
Ownership Questions (Ask These First)
1. Who owns the advertising accounts? If the vendor runs ads through their own accounts, you own nothing. Patient data, audience performance, retargeting lists — it all stays with them when the contract ends. Require that campaigns run through ad accounts you own.
2. Who owns the patient contact data? Pre-screened patient records, contact information, and eligibility data should live in systems you control — not the vendor’s CRM. Ask for your data export policy in writing before signing.
3. What happens when we stop paying? The right answer: you keep your accounts, your data, and your campaign history. The wrong answer: anything involving “proprietary platform” or “transition fee.”
Compliance Questions
4. Are you a HIPAA Business Associate? If the tool touches patient health information (pre-screening responses, health condition data), the vendor must sign a Business Associate Agreement. If they hesitate, the conversation is over.
5. How is pre-screening data stored and for how long? Encrypted at rest and in transit. Role-based access only. Retention policy that matches your IRB requirements. Get specifics, not assurances.
6. Has your system been audited for IRB compliance? Tools that automate patient contact need to operate within the bounds of your IRB-approved recruitment protocol. Ask how they accommodate protocol-specific restrictions on contact methods and messaging.
Performance Questions
7. What is your average cost per enrolled patient, by indication? Any vendor with real results can answer this with specifics. “It varies” is not an answer. Push for ranges by condition category — diabetes, cardiology, CNS — and compare to your current cost.
8. What is your average pre-screen pass rate? Benchmark: 25–45% for well-targeted campaigns. If a vendor claims above 50%, ask for the methodology — either the criteria are loose or the data is cherry-picked.
9. Can you show me three sites with similar indication and geography and their actual enrollment outcomes? References from real sites in comparable therapeutic areas — not case studies — are the only meaningful performance evidence.
Integration and Implementation Questions
10. How does your system integrate with our existing calendar and CTMS? The answer should name your specific systems or acknowledge that custom integration work is needed. “Integrates with most platforms” means it probably does not integrate with yours without significant setup.
11. What does implementation actually require from our coordinators in the first 30 days? Underestimated implementation burden is the most common reason AI tools fail at sites. Get a specific time estimate in hours per week for your staff during setup and ongoing operation.
12. What is your SLA for response time issues? If the automated system goes down at 9pm on a Friday and patients are submitting inquiries, what is the resolution time? A vendor with real infrastructure has a specific answer. A vendor running on cobbled-together tools will not.
Your Evaluation Action Plan
- Print these 12 questions before your next vendor demo
- Note which questions the vendor deflects or answers vaguely — that pattern is the red flag
- Require a Business Associate Agreement before any data sharing, even in a pilot
- Ask for the ad account ownership in writing before signing — not after
- Talk to two reference sites before committing, not after