Why Bioanalytical Testing?
Testing under formal US Food and Drug Administration (FDA) bioanalytical guidelines provides critical information to clinical studies and a higher probability of success for clinical trials at any phase of development. Bioanalytical validation is designed to provide uniformly reliable data. Endocrine Sciences has placed a great deal of effort into building the systems and processes necessary to meet these quality standards that clinical trial sponsors have come to expect.
Bioanalytical testing entails:
- Meeting the requirements for reference standards and standard curves.
- Accurate quality control of analytes to meet FDA and European Medicines Agency (EMEA) acceptance criteria.
- Comprehensive documentation requirements that exceed Clinical Laboratory Improvement Amendments (CLIA) standards.
- Separate lab spaces for clinical and bioanalytical testing.
Over the years, the FDA and EMEA have provided guidance documents for bioanalytical testing methods. Endocrine Sciences adheres to FDA guidance recommendations and provides a comprehensive plan and level of testing to ensure high-quality results.
Endocrine Sciences recognizes that clinical trial testing is moving to a higher level of scrutiny for submission with the US and European Union regulatory agencies and takes a conservative approach to clinical trials testing by following and exceeding requirements for bioanalytical validation, bioanalytical assay acceptance criteria, and incurred sample repeats. This higher commitment to quality does not guarantee regulatory acceptance, but is a prudent precaution.
Additional information about the FDA and EMEA bioanalytical guidance documents:
FDA Bioanalytical Method Validation Guidance for Industry
European Medicines Agency Guideline on Bioanalytical Method Validation