Novella’s Diagnostics team offers specific experience in regulatory consulting, design and execution of in vitro diagnostics (IVD) clinical studies. Our diagnostics experts are experienced in IVD clinical protocols, clinical monitoring plans, sample and device tracking, data collection and analysis, IVD clinical reports, and regulatory agency submissions across North America, Europe and Asia.
Unique Regulatory Requirements
Diagnostics companies face unique regulatory challenges. Our regulatory specialists have practical experience in successful submissions with both US and international regulatory bodies, and can help diagnostics customers determine the most effective and efficient regulatory path. In the US that may be 510(k) clearance, PMA or CLIA waiver, and Novella has frequent contact with CDRH’s Office of In Vitro Diagnostics and Radiological Health (OIVD).
Diagnostics trials often require complex layers of data analyses for primary endpoints, with data needed on both the existing “predicate” method and the new subject diagnostic. Samples may vary (e.g., saliva for investigational diagnostic vs. tissue for comparator method). Often the comparator diagnostic requires multiple tests during follow-up, depending upon previous test results, so data sets can vary by subject making data collection and completeness more challenging than a drug or device study. Novella’s data management and statistical analysis teams are experts in the different types of analyses required for qualitative diagnostic tests or quantitative diagnostic assays.
Novella routinely takes a customized approach to study monitoring, considering both site and study needs. Whether it involves a risk-based approach, monitoring of both collection and testing sites, or sample tracking and management, we can provide the optimal monitoring solution for your particular study.
- Test and assay development
- Biomarker identification
- Comprehensive genomic services
- Analytically validated panels
- NGS panel development
- Functional verification
- Design validation
- GLP compliant, CLIA certified, CAP accredited
- Companion Diagnostics
- Performance verification
- Design validation
- Core / Central lab services
- Comparator testing
- Interference factor testing
- Concomitant medication testing
- Sample storage / banking
In Vitro Diagnostics Experience
Our diagnostics experience spans complex assays based on multiple analyte types and formats, companion diagnostics, detection devices and screening tests for use at point-of care, central lab and at home. Clinical study sample sizes span from a dozen to more than 45,000, and our therapeutic range includes cardiovascular, oncology, women’s health, infectious agents and metabolic disease.