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Ahmedabad , India
Specialized studies for diagnostic devices, assays, biomarkers, and digital health tools
Deep expertise in IVD and diagnostic-specific regulatory pathways (FDA, CE-IVD, IVDR)
Ensuring accessibility, accuracy, and faster results for improved patient outcomes
Evidence generation on sensitivity, specificity, predictive value, and real-world utility
Preparation of dossiers, CERs, and submissions fully aligned with diagnostics-focused regulatory pathways.
Engaging with patients and physicians to ensure high recruitment and retention in long-term diagnostic studies.
Use of advanced biostatistics and AI-driven diagnostic interpretation for faster, more reliable results.