These CROs run IVD and companion diagnostic performance studies—analytical and clinical validation, sample management, and regulatory filing support under IVDR and FDA guidance.
Diagnostics Specialists
Provides statistical planning and performance evaluation analyses for diagnostic and companion diagnostic trials. Aligns study design with IVDR and FDA requirements for sensitivity, specificity, and clinical utility assessments.
Manages IVD and CDx clinical performance studies, including analytical validation and clinical evaluation. Delivers protocol design, quality system setup, and submission-ready documentation under EU IVDR and FDA CDx guidance.
Conducts diagnostic clinical performance and usability assessments under IVDR. Offers personalised project management and statistical analysis for small-to-mid-sized diagnostic sponsors.
Guides diagnostic manufacturers through assay validation, clinical studies, and regulatory filings. Specialises in performance protocols and post-market clinical follow-up for IVDs.
Supports diagnostic trial execution with sample management, central lab services, and statistical reporting. Advises on CE-Mark and FDA 510(k) submissions for IVDs.
Runs PMCF and performance evaluation for diagnostics under MDR/IVDR. Supplies regulatory documentation, CER/CEP writing, and statistical analysis.
Manages IVD clinical investigations and regulatory consultancy for IVDR compliance. Delivers trial management, data collection, and technical file preparation.
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