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:
Many eClinical vendors started with large pharma trials in mind. But IDE trials have very different needs:
Adaptive and iterative designs
Device-specific endpoints
Combination products
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?
Enterprise platforms often come with:
Long validation cycles
Complex implementation
Vendor-controlled configurations
For an IDE trial — where FDA submission timelines matter — you can’t afford delays. Cloudbyz offers:
A pre-validated system (21 CFR Part 11, GxP, ISO, GDPR, HIPAA, China PIPL-ready)
Low-code, self-service configuration
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?
A common frustration with big enterprise platforms: hidden costs.
Licensing tied to large pharma pricing
Forced services contracts
Change order fees for basic updates
At Cloudbyz, we believe in transparent total cost of ownership:
Flexible licensing
No mandatory long-term services contracts
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?
IDE trials often rely on diverse, evolving ecosystems:
Imaging core labs
Diagnostic partners
Registries
Wearables and apps
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?
In today’s device trials, you don’t need the biggest system — you need the right-fit platform:
Purpose-built for IDE trials
Pre-validated and inspection-ready
Flexible and self-service
Open and integrative
Transparent and cost-effective
That’s what Cloudbyz delivers — and why more device sponsors and CROs are making the switch.