Central Lab Services & Diagnostic Assay Validation
New Day Bioresearch supports diagnostic developers and clinical trial sponsors with both clinical trial sample testing and regulatory-grade diagnostic assay validation. Our CLIA-certified and ISO 13485:2016-compliant laboratory delivers precise, compliant results from feasibility through final submission, including support for 510(k) and CE-IVDR regulatory pathways.
Central Lab Services for Clinical Trials
Our central laboratory services for clinical trials are designed to meet the demands of modern diagnsotic development. We offer full-service support for processing trial-collected biospecimens with rapid turnaround times and dependable logistics.
Our services include:
🔹 Patient Sample Processing & Storage
Timely and compliant handling of samples across multi-site studies.
🔹 Sample Logistics Management
End-to-end tracking and integrity assurance.
🔹 Data Integrity & Security
Robust systems for secure result delivery and analysis.
Diagnostic assay validation for ivd submissions
We deliver thorough IVD performance evaluation and validation testing to meet global regulatory standards for 510(k), PMA, and CE-IVDR compliance testing. All studies are conducted in alignment with FDA assay validation requirements and CLSI standards.
Validation services include:
🔹 Method Validation & Verification Ensuring your new diagnostic test meets regulatory and clinical trial protocol development standards.
🔹 Precision & Linearity Testing
Using CLSI standards to validate reproducibility and ensure compliance.
🔹 Limit of Detection (LoD) & Limit of Quantitation (LoQ)
Essential for clinical testing laboratories to determine the sensitivity and specificity of assays.
🔹 Interference & Cross-Reactivity Studies
Identifying potential issues that could impact clinical accuracy.
Comparator Studies & Method Verification
Comparator studies and a cornerstone of diagnostic test development, especially for regulatory filings such as 510(k) and CE-IVDR. We offer method verification and side-by-side testing against gold-standard assays using CLSI-referenced methodologies.
Our process includes:
🔹 Comparator Selection & Procurement Industry-standard assays used for reliable benchmarks. 🔹 Sample Collection & Integrity Management Clinical trial sample testing with documented chain of custody. 🔹 Data Analysis & Interpretation Expert interpretation for confident decision-making. 🔹 Regulatory-Ready Documentation
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Why Choose New Day Bioresearch?
✅ Certified Excellence – CLIA-certified and ISO 13485:2026 accredited for quality assurance.
✅ Specialized focus – Oncology, infectious disease, and women’s health assay expertise.
✅ Integrated Solutions – Seamless connection between lab services and regulatory strategy.
✅ End-to-End Support – From assay validation to comparator study to submission.
Partner with New Day Bioresearch for reliable clinical trials laboratory services that drive innovation and ensure analytical quality in diagnostics.
Contact us today to discuss your central lab services and assay validation needs!