Cloudbyz CTFM for Medical Device Trials: From Investigator Agreement to Long-Term Follow-Up

Written by Smit Shah | Oct 27, 2026, 7:00:00 AM

Cloudbyz CTFM supports medical device trials across their full life: it tracks signed investigator agreements before sites start, builds budgets at procedure level for implant, imaging and follow-up visits, manages device-specific costs with limits, splits payments between hospital departments and investigators, and forecasts spend across multi-year follow-up. Cloudbyz CTFM is built natively on Salesforce, with Cloudbyz CTMS, EDC and eTMF on the same platform, and suits MedTech companies of every size, from early-stage device developers to global multinationals.

A device study in Cloudbyz CTFM

Stage	What CTFM handles	Why it matters
Site start-up	Investigator agreement tracked to execution	21 CFR 812.43 requires a signed agreement before participation
Budget	Procedure-level fees for implant, imaging and follow-up visits	Device visits vary widely in cost
Device-specific costs	Training, proctoring, imaging reads, device returns, with maximum quantities per unit	Keeps non-procedure costs within agreed limits
Payments	Splits between hospital, imaging department, investigator or other payees	Device studies often pay several parties per site
Follow-up	Forecast across months or years after the last implant	Spend continues long after enrolment ends
Changes	Amendment scenarios and change order forecasting	Device iterations change remaining visits and costs

Why the rules matter

US: under the investigational device exemption rules, sponsors must obtain a signed agreement from each investigator, including financial disclosure, before they take part (21 CFR 812.43). Activating a site without it is a compliance gap.
EU: device clinical investigations fall under the Medical Device Regulation (Regulation (EU) 2017/745), including arrangements for participant damage compensation, so multi-country device studies need agreements and costs tracked by country.
Records: agreements and financial records are essential records, and ICH E6(R3) principles on documented agreements and data governance apply to how they are kept (ICH E6(R3), EMA Step 5).

Why one platform helps device teams

With Cloudbyz CTMS on the same platform, the team can confirm an investigator agreement is executed before a site is activated. With Cloudbyz EDC, completed implant and follow-up visits create earned amounts and accruals in real time. With Cloudbyz eTMF, executed agreements can be filed as essential records. Cloudbyz eTMF is already used by medical device customers to manage clinical documentation.

See a device study in CTFM

The Cloudbyz team can walk through a device study in Cloudbyz CTFM, from agreements to long-term follow-up. Book a demo or visit cloudbyz.com.

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