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If you’re running IDE trials, choosing the right eClinical partner can make or break your trial’s efficiency, compliance, and cost-effectiveness. Yet many sponsors and CROs feel stuck between two extremes:
1️⃣ Oversized enterprise systems that bring complexity, high costs, and pharma-centric workflows
2️⃣ Niche point solutions that lack integration, scalability, or validation
At Cloudbyz, we work with medical device sponsors and CROs who’ve experienced this tension first-hand — and we often hear:
"I wish we’d asked better questions before we signed that last eClinical contract."
So here are four key questions to consider as you evaluate your options:
Is the platform truly built for IDE trials — or repurposed from pharma?
Many eClinical vendors started with large pharma trials in mind. But IDE trials have very different needs:
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Adaptive and iterative designs
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Device-specific endpoints
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Combination products
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Post-market surveillance workflows
Cloudbyz was purpose-built with 25+ years of device trial expertise — and it shows in our platform’s flexibility and fit for today’s IDE workflows.
Before signing, ask:
Will this system flex to the way we run device trials — or will we be forced to work around a pharma-centric design?
Will the platform help us move faster — or slow us down?
Enterprise platforms often come with:
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Long validation cycles
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Complex implementation
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Vendor-controlled configurations
For an IDE trial — where FDA submission timelines matter — you can’t afford delays. Cloudbyz offers:
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A pre-validated system (21 CFR Part 11, GxP, ISO, GDPR, HIPAA, China PIPL-ready)
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Low-code, self-service configuration
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Support for rapid study startup and inspection readiness
Before signing, ask:
How fast can we go live? How easy will it be to adapt mid-study? Will we be in control — or at the mercy of the vendor?
How transparent are the costs — and will we control them?
A common frustration with big enterprise platforms: hidden costs.
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Licensing tied to large pharma pricing
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Forced services contracts
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Change order fees for basic updates
At Cloudbyz, we believe in transparent total cost of ownership:
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Flexible licensing
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No mandatory long-term services contracts
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Self-service tools so your team can manage studies without constant vendor dependency
Before signing, ask:
Will we have true cost transparency? Can we scale up or down as needed — or will we be locked in?
Can the platform work with our broader ecosystem — or will it lock us in?
IDE trials often rely on diverse, evolving ecosystems:
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Imaging core labs
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Diagnostic partners
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Registries
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Wearables and apps
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Safety systems
Cloudbyz is an open platform — built on Salesforce — with validated integrations and open APIs.
You’re free to work with the partners and tools you choose.
Before signing, ask:
Will this platform integrate with our ecosystem — or force us into a closed vendor stack?
Final Thought: Fit Matters More Than Size
In today’s device trials, you don’t need the biggest system — you need the right-fit platform:
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Purpose-built for IDE trials
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Pre-validated and inspection-ready
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Flexible and self-service
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Open and integrative
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Transparent and cost-effective
That’s what Cloudbyz delivers — and why more device sponsors and CROs are making the switch.
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