SimpleTrials is described as a cloud CTMS with an eTMF for sponsors, CROs and sites. This page shows what a standalone CTMS leaves to other systems, the questions to ask, and how Capture puts CTMS, eTMF and EDC in one platform for you to test.
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Questions per vendor
8
Capture CTMS and eTMF
Full Platform
What to know first
The vendor
Software directories describe SimpleTrials as a cloud-based clinical trial management system built around study and site management, subject tracking, financials and risk indicators, with document management and an eTMF. A 2017 trade release for version 2.0 said it added site contract and payment management that connects to subject and visit tracking, and a 2018 release described an electronic visit report tied to the visit calendar and eTMF. Directories list compliance statements and pricing; we do not repeat either.
These are vendor and directory descriptions, many of them years old, and we have not tested the product. The honest position is that a small, focused CTMS can be an excellent choice for a team that already has an EDC it is happy with. The question this page addresses is for teams that have not yet bought either, or that are tired of keeping two systems in step.
For the conceptual split, read EDC versus CTMS, EDC versus eTMF and eTMF versus a shared drive. For a shortlist view, see best CTMS for small studies.
Decision matrix
The SimpleTrials column is a question to put to the vendor. Capture's column comes from its product and pricing pages.
| Question | Ask SimpleTrials | Capture's answer |
|---|---|---|
| Enrolment and visit status | Is it entered by hand, imported, or read from the EDC? Which EDCs? | Enrolment is shown from the same data as the EDC; nothing to reconcile. |
| Site management | How are sites, milestones and start-up tracked? | Sites, milestones, enrolment and study tasks in one CTMS view. |
| Trial master file | How are documents versioned, and what is in the audit trail? | eTMF stores TMF documents with versions and an audit trail of every change. |
| Contracts and payments | What is included and what is priced separately? | Not claimed. Handle site contracts and payments outside Capture. |
| Data capture | Which EDC do we use alongside, and who qualifies the pair? | EDC, ePRO and eConsent in the same platform, one audit trail. |
| Access control | How are sponsor, CRO and site users separated? | Role-based access with PII segregation; separate site coordinator portal. |
| Exit | What export do we get for the TMF and tracking data? | CSV/Excel with data dictionary for study data; confirm TMF export in a demo. |
| Total cost | What is the 24-month total for our studies and users? | Full Platform pricing on the pricing page; sandbox free. |
Verify every SimpleTrials statement on the vendor's own site. No SimpleTrials pricing or compliance claim is made here.
Build a study in the free sandbox, enrol test participants and watch enrolment flow into the study view. No card.
Single record
In a standalone CTMS, the number on the dashboard is only as current as the last person or interface to update it. In Capture, the study overview and the data come from the same place, so a site's enrolment is the enrolment recorded in the EDC. This is a demo-data view of a study status overview.
Stack shape
Decision aid
A focused CTMS such as SimpleTrials may suit you. Ask how it reads from your EDC.
Evaluate SimpleTrials or similar on that point; Capture does not claim it.
Test Capture, where both share a record. Start with the lightweight versus enterprise guide.
Compare plan cost with the sandbox first; see the academic pages.
Ask each vendor for a sample TMF index and audit trail export.
Process
Sites, milestones, documents, enrolment, tasks and payments. Mark what must stay.
Send the table above to each vendor and ask for written answers.
Set up two sites, enrol test participants and compare the overview with your tracker.
Compare the seam, the missing features and the 24-month cost.
Next steps
See clinical trial management systems explained, the Capture eTMF page, and lightweight versus enterprise EDC. For vendor audits, use the EDC vendor audit checklist. For costs, see the EDC software pricing guide and the pricing page.
Public listings describe SimpleTrials, from Trial By Fire Solutions, as a cloud CTMS with eTMF for sponsors, CROs and sites. Confirm the current product, ownership and modules with the vendor.
Yes, both are in the Full Platform plan, in the same system as EDC, ePRO and eConsent. Capture does not claim site contract, payment or budget management.
We make no claim about an integration between the two. If you want a mixed setup, ask both vendors what import or export is supported and test it before committing.
We do not quote SimpleTrials pricing; directory figures can be out of date. Ask the vendor for a written quote. Capture has a free sandbox and published plans on the pricing page.
Not always. A spreadsheet can be enough for a few sites. Once you have several sites, milestones and a master file to keep inspection-ready, a CTMS and eTMF save time. See the best-CTMS-for-small-studies guide.
Capture is ISO 27001 certified, 21 CFR Part 11 compliant, GDPR compliant, HIPAA compliant and ICH GCP E6(R3) compliant, with EU and US data hosting. Validated use remains a shared responsibility with the sponsor.
Yes. Capture supports Phase 1 through Phase 3, including SDV per field, freeze and lock, blinded roles and multi-site filtering.
Build a study, enrol test participants and see the overview in the free sandbox. No credit card.