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Increasingly, even devices and diagnostics following 510(k) approval are requiring clinical data.  Optimal research design can involve complicated statistical considerations and limited availability of samples. Even when guidances are available, they are often vague or not applicable to a Sponsor’s particular experimental situation. By focusing on choosing an acceptance criterion that is proportional to the regulatory requirement, Accudata Solutions helps Sponsors choose the right experimental design and analysis strategy.

Clinical Data Analysis Biostatistics Research Pharmaceutical Medical Device Diagnostics Nonclinical

Statistical design and analysis of:

  • Design Verification and Validation studies

  • Reproducibility studies

  • Diagnostic Performance studies(accuracy, precision, agreement, PPV, NPV, concordance, ROC)

  • Calibration to Reference Standards (WHO-IS, NIBSC)

  • Methods comparison studies(e.g. CLSI)

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