Your trusted CRO partner for studies that matter
Clinical Research
This powerhouse of thoughtful, clinical research professionals delivers a robust engagement process that ensures great ideas make it out of the R&D lab and into the world. 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 study design research and review to site closeout and study reporting, CovarsaDx takes entire clinical and quality programs from study concept to data analysis with fully compliant trial designs and quality management. CovarsaDx studies are designed and executed with precision management of each trial activity, delivering the consistency your product demands through:
- Optimized team structure for consistent trial management and effective sponsor and site communication;
- Streamlined processes to facilitate decision-making and reduce delays;
- A unique business model that provides premium services and highly experienced professionals at cost-effective rates throughout every study.
With a focus on quality and compliance, CovarsaDx ensures that every aspect of a study—from site selection to regulatory submissions—is backed by robust analytical verification and validation (V&V) processes. Through comprehensive verification, we confirm that diagnostic assays and devices meet predefined performance standards, while validation studies assess their accuracy and reliability in real-world settings. By meticulously evaluating key factors such as precision, sensitivity, specificity, and reproducibility, we help sponsors generate regulatory-compliant data that accelerates product approval and market success.
Your Trusted CRO Partner for Studies That Matter
When you partner with CovarsaDx, you’re getting more than a CRO. You’re gaining a dedicated team of clinical study experts, regulatory specialists, and quality professionals committed to advancing diagnostics and medical innovation. We don’t just run studies; we ensure that every trial is strategically designed, precisely executed, and fully optimized for regulatory success and real-world impact. Our meticulous approach helps bring breakthrough diagnostics and medical technologies to market with confidence and speed.
Your work is important. Let’s make sure it moves in the right direction with a CRO partner exclusively dedicated to IVD and medical device studies, delivering results that matter, reliably.
Your work is important. Let’s make sure it moves in the right direction with a CRO partner exclusively dedicated to IVD and medical device studies, delivering results that matter, reliably.