1. Is it built for sites?
Many well-known systems are aimed mainly at sponsors and CROs. Ask who most of the vendor's customers are, and ask to see a typical day for a coordinator and for a billing person.
2. What's included, and what's extra?
List what you need: CTMS, eSource, eConsent, eReg or eISF, monitor access and billing. Then check whether each is included, sold separately or handled by a partner.
3. How does it handle money?
- Can it price a schedule of activities?
- Does it create invoices from completed visits?
- Can it track payments, stipends and budget vs actuals?
4. How does it control data and access?
- Are permissions enforced by role, including for blinded data?
- Does the audit trail capture who, what, when and why?
- What can a monitor view or download?
5. Can the vendor back up its compliance claims?
Don't stop at a badge on a website. Ask for security reports and validation documents, how the system supports 21 CFR Part 11, and whether the vendor will sign a HIPAA business associate agreement if one is needed. Have your compliance advisor review the answers.
6. How hard is it to start, and to leave?
- Who builds your first study, and how long does it take?
- What training and support come with it?
- Can you bring in existing studies and documents?
- Can you export your records if you leave?
7. What will it really cost?
Compare the total over several years, including setup, modules, per-study or per-user fees, training and data export. Check whether a free or low-cost tier has limits you'll soon reach.
Test it with a real study
Ask for a demo using one of your own protocols, and include your coordinator and billing lead. Have the vendor show a visit from scheduling all the way to invoice. See how PAS OneCore handles it, or read what a CTMS does.