If you’ve worked on IDE trials, you’ve likely seen the problem firsthand: Most legacy eClinical platforms were built for large pharma, not for the agile, iterative world of medical device sponsors and CROs.
But today’s IDE trials demand more:
Faster FDA submissions
Adaptive trial designs
Hybrid and global studies
Lower cost of ownership
Built-in inspection readiness
That’s why we built Cloudbyz — a right-sized, validated eClinical platform designed specifically with IDE trial sponsors and CROs in mind.
An IDE trial is not a pharma trial — and your eClinical platform shouldn’t treat it like one.
Device studies require:
Device-specific workflows
Adaptive and iterative designs
Combination product flexibility
Post-market surveillance readiness
Data that’s easily exportable for FDA submissions
At Cloudbyz, we bring over 25 years of device trial experience — baked right into our platform — to help you move faster, stay compliant, and stay inspection-ready.
When submission timelines are tight, you need a system that helps, not hinders.
Cloudbyz is fully pre-validated and maintained to meet:
FDA 21 CFR Part 11
GxP
ISO standards
GDPR / HIPAA
China PIPL requirements
So you can start studies sooner, streamline FDA submissions, and ensure inspection readiness from day one.
Today’s device trials aren’t one-size-fits-all. Many now include:
Hybrid designs (site-based and remote)
Global geographies (US, EU, China, Rest of World)
Adaptive trial designs
Decentralized endpoints — wearables, sensors, SaMD
Cloudbyz delivers the flexibility you need with modular eClinical coverage and open APIs — not a locked-down, monolithic system.
We hear it all the time: sponsors and CROs are frustrated with the hidden costs and rigid contracts of traditional platforms.
With Cloudbyz, you get:
A low-code, self-service platform
Transparent total cost of ownership
User training provided by our expert team
No forced dependency on long-term vendor services
That means lower costs and greater flexibility — especially valuable for small to mid-sized sponsors and CROs.
IDE trials often involve specialized partners and data sources:
Imaging core labs
Diagnostic partners
Registries
Wearables and app data
Safety reporting systems
Cloudbyz supports validated integrations with your entire trial ecosystem — using open APIs and partner networks — with no proprietary lock-in.
Here’s what we hear from teams making the switch:
“We need a system built for IDE workflows — not pharma workflows.”
“We want the flexibility to run hybrid and global studies.”
“We’re tired of inflated costs and locked-in services.”
“We need faster FDA submission readiness.”
“We want inspection readiness baked into the system.”
If you’re launching new IDE trials — or considering a better platform for your current studies — Cloudbyz offers:
Faster study startup
Lower total cost of ownership
FDA submission and inspection readiness
Flexibility for hybrid and global studies
A modern, user-friendly experience