Your trusted CRO partner for studies that matter
IVD and Medical Device Clinical Research Services
At CovarsaDx, we specialize in IVD and medical device clinical research services that help sponsors bring innovative diagnostics and devices to market faster. As a trusted CRO for diagnostics and devices, we offer end-to-end trial support—from study design and site selection to data management and FDA submission preparation. Our expertise spans early feasibility studies through pivotal trials, and we’re known for delivering flexible, regulatory-ready solutions across therapeutic areas including respiratory, GI, women’s health, and infectious disease. With CovarsaDx, clients engage in a thorough collaborative process:
Study Design
Protocol Development
Patient Recruitment
Site Selection
Study Enrollment
Negotiation
Study Materials Development
Site Initiation and Training
Contract Development and Budget
Site Monitoring
Data Management
Oversight Statistical Analysis
Study Reporting
Verification and Validation (V&V)
From Design to Submission: How We Deliver Clinical Research That Works
At CovarsaDx, our clinical operations are built to deliver consistent, audit-ready execution for every trial. We combine precision study management with transparent communication and agile processes that drive real progress.
What sets us apart:
- A cross-functional team model that ensures regulatory, clinical, and quality alignment from day one
- Streamlined workflows that minimize delays and reduce sponsor burden
- A flexible business model that pairs premium CRO expertise with cost efficiency
With a focus on IVD and medical device clinical research services, we ensure every study milestone supports your path to FDA clearance or approval.
Built-In Compliance: Quality and Regulatory Integration
Quality isn’t an afterthought—it’s embedded into every CovarsaDx study. In partnership with our quality assurance team, we implement comprehensive verification and validation (V&V) strategies to confirm your product’s safety, accuracy, and performance.
- Analytical verification confirms your assay or device meets predefined performance standards
- Validation studies evaluate accuracy, sensitivity, specificity, and reproducibility in real-world use
This commitment to quality ensures you generate regulatory-grade data that supports smooth regulatory submissions and faster market access.
More Than a CRO—A Strategic Partner in Innovation
When you work with CovarsaDx, you gain a partner exclusively focused on IVD and medical device clinical trials. Our team of clinical researchers, regulatory consultants, and QA professionals understands the unique requirements of diagnostics and works collaboratively to advance products that improve lives.
We don’t just manage studies—we shape them for real-world impact and regulatory success.
Let’s Accelerate Your Next Trial
Your innovation deserves a partner that knows the path and walks it with you.
Discover how our IVD and medical device CRO services can support your next clinical trial.