Rethink What’s Possible for Your IDE Trials with Cloudbyz

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.

Built for IDE Trials — Not Pharma Templates

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.

Pre-Validated for FDA Compliance — Accelerate Your IDE Submissions

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.

Designed for Modern IDE Trials — Hybrid, Adaptive, and Global

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.

Transparent Costs. True Self-Service. No Surprises.

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.

An Open Ecosystem — Integrate With the Tools You Already Use

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.

Why More Clients Are Choosing Cloudbyz?

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.”

Ready to Rethink What’s Possible for Your IDE Trials?

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