The short answer

Not every site needs one on day one. A site running a single simple study may manage for a while with careful logs. The case for a clinical trial management system grows as studies, staff and sponsors overlap, because that's when tracking by hand starts to break down.

Signs it's time

  • You're running more than one study, and each has its own tracker
  • Visit windows are calculated by hand or checked only when someone remembers
  • Follow-up tasks live in inboxes, with no shared list across studies
  • Staff credentials, training and the delegation log are kept apart from the study
  • Nobody can quickly say how a study is doing against its budget

A site CTMS isn't a sponsor CTMS

Sponsors and CROs use a CTMS to oversee many sites. Those systems can be far more than a small site needs, and they're often built around someone else's view of the study. A site CTMS helps one site run its own subjects, visits, staff, documents and money.

What to check before adding a system

The biggest risk for a small site is adding one more place to keep things up to date. Before you commit, ask:

  • Will this replace tools, or sit alongside all of them?
  • Does it cover documentation and billing, or only one of them?
  • Can current staff learn it without a dedicated administrator?
  • Can you control what each role sees, including blinded data?

Our guide on how to choose a CTMS has more questions to ask a vendor.

Where PAS OneCore fits

PAS OneCore combines study operations with eSource, eConsent, regulatory documents and sponsor invoicing. Read more about our CTMS for small research sites.

Not sure if you're ready?

Tell us how many studies you're running and how you track them now. We'll give you a straight answer on whether it's worth changing yet.

Talk to us