Comparator Testing Services
At New Day Diagnostics, we stand as your comprehensive, concept-to-market partner, committed to the realization of groundbreaking diagnostic innovations. Our Comparator Testing Services are designed to ensure that your diagnostic products are not only innovative but also perform at par or exceed existing market standards. By aligning our services with our core mission to empower lives through advanced diagnostics, we aim to elevate the reliability and effectiveness of your diagnostic solutions.
tailored to meet your needs
Comparator & Predicator testing
Our Comparator Testing Services are designed to encompass all essential aspects of comparative analysis, ensuring a comprehensive evaluation of your diagnostic product. Here’s how we support these key components:
comparator selection
Identifying appropriate established diagnostic products that serve as benchmarks for comparison.
comparator study design
Delivering comprehensive reports that highlight the comparative performance of the diagnostic product, facilitating strategic market positioning.
sample collection & management
Coordinating the collection and handling of samples required for testing, maintaining integrity and compliance.
data analysis & interpretation
Employing advanced statistical methods to analyze test results, providing clear, insightful comparisons between products.
regulatory documentation
Preparing detailed documentation of the comparator testing process and outcomes for regulatory submissions to FDA, IVDR, etc.
performance reporting
Delivering comprehensive reports that highlight the comparative performance of the diagnostic product, facilitating strategic market positioning.
Comparator testing is a critical phase in the development of diagnostic tools, involving the comparison of a new diagnostic product against one or more established products (comparators). This process is essential for demonstrating equivalency, superiority, or non-inferiority in terms of efficacy, accuracy, and usability. Comparator testing provides vital data that support regulatory submissions, market positioning, and clinical adoption by showcasing how the new product stands in the context of current standards and practices.
Contract service provider for comparator testing
what to look for
Selecting the right partner for comparator testing is crucial for your diagnostic product’s success. Essential attributes to consider include:
EXPERTISE IN DIAGNOSTIC DEVELOPMENT
A team with extensive experience in diagnostic product development and testing ensures a deep understanding of the nuances involved in comparator testing.
STRATEGIC APPROACH
A provider that offers strategic guidance on comparator selection and test design to meet specific objectives, whether it’s demonstrating equivalency, superiority, or non-inferiority.
REGULATORY PROFICIENCY
An understanding of the regulatory landscape is essential for designing comparator tests that meet the requirements of regulatory bodies and support successful submissions.
QUALITY AND PRECISION
Quality and Precision: A commitment to high-quality testing procedures and precise data analysis ensures reliable and actionable results.
PARTNER WITH NEW DAY DIAGNOSTICS
At New Day Diagnostics, we combine our expertise in analytical validation with a commitment to quality, collaboration and innovation. As your end-to-end partner, we are dedicated to transforming your diagnostic innovations into reality from inception to commercialization, ensuring they are ready to make a meaningful impact on healthcare and patient lives.
Discover how our analytical validation services can accelerate the development of your diagnostic solutions. Contact us today and take the next step towards realizing your diagnostic breakthrough with us.