biomarkers

Clinical biomarkers are becoming increasingly important for faster decision making, accelerating drug development, reducing uncertainty in regulatory decisions during drug development, and considerations for personalized medicine, immunotherapeutics and diagnostics. The ambiguity of regulatory compliance of clinical biomarker analysis is made more complicated by there being limited regulatory guidance to follow and a wide variety of actual practices of molecular biomarker bioanalysis from site to site with a mixture of GLP, GCP, ‘fit-for-purpose’ and general quality considerations.

BioAccurate’s Dr. Chris Tudan has > 15 years of experience working with cross-functional teams to enable biomarker and bioanalytical program quality within the clients’ processes while providing effective auditing support, vendor risk assessment consultation and issues remediation in pursuit of defendable data within a realm of constant change in analytical technologies, therapeutics, and industry and regulatory expectations.

Refer to the Services provided by BioAccurate and Chris’s LinkedIn page for more about BioAccurate’s unparalleled technical and compliance service opportunities for your team, which includes NGS, Immunotherapeutics and animal health support.