Free guide
CTMS buyer's guide: questions to ask any vendor
Use these questions with every vendor you talk to, including us. Ask for answers in writing.
01Fit
- Is the system built for studies of our size and number of sites?
- Can we see it working with a protocol like ours, not only a polished sample?
- Which features are available today, and which are on the roadmap?
02Setup
- How long until our first study is live, and what work falls on our team?
- Do we build the study from a blank system, or does it start from our protocol?
- Who helps us set up, and is that included in the price?
03Pricing
- What is the total yearly cost per study, including setup, users and support?
- What costs extra: integrations, more sites, more studies, data exports?
- What happens to our price at renewal?
04Compliance
- Which 21 CFR Part 11 controls are built in, such as audit trails, e-signatures and access control?
- What validation documents do you provide, and what must we do ourselves?
- Where is our data stored, and can you sign a BAA if we ever need one?
05Data and exit
- Can we export all of our data in a standard format at any time?
- Does it connect to our EDC, eTMF and finance tools, and at what cost?
- What happens to our data if we leave?
06Support
- Who do we call when something goes wrong, and how fast do they respond?
- Can you provide people, not just software, if our team is stretched?
- Can we talk to a current customer with a similar study?
This guide is general information, not legal or regulatory advice.
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