What a CTMS does
A clinical trial management system keeps the operational side of a study in one place. Depending on the product, that can include:
- Study start-up tasks and milestones
- Subject enrollment and visit scheduling
- Monitoring visits and follow-up issues
- Staff, tasks and reporting
- Budgets, invoices and payments
Sponsor CTMS vs site CTMS
A sponsor or CRO CTMS oversees many sites and studies, with a focus on milestones, monitoring and portfolio reporting. A site CTMS helps one research site or network run its own work: which subjects are due, what staff need to do, and what can be billed.
The difference matters when you shop for one. A product built to oversee hundreds of sites may be far more than a doctor office needs, and it may not help with site-side billing.
CTMS vs EDC, eSource and eTMF
- CTMS: manages study operations
- EDC: collects study data for analysis, usually in the sponsor's system
- eSource: holds the original record of what happened at a visit
- eTMF: stores the sponsor's trial master file
- eISF or eReg: stores the site's regulatory documents
- EHR: holds a practice's patient care records
When does a site need one?
Spreadsheets can work for a single simple study. It's usually time to look at a CTMS when visits or invoices start getting missed, when several studies overlap, or when staff spend more time tracking work than doing it.