Based in San Francisco, California, our team possesses 30 years of experience in the healthcare arena including 20 years in the product development industry with biotech and pharmaceutical companies, medical device/diagnostic companies, small and large companies, CROs and academia.

Our areas of expertise include management level positions in quality and compliance (quality systems development and process improvement), clinical quality assurance units, clinical operations, clinical trial management/ site monitoring, managing studies at investigational sites (Research Nurse), and educating and training personnel (CROs, pharmaceutical and biotech companies, investigational sites, academia, government agencies).

Further, examples of our expertise includes establishing and overseeing clinical quality assurance units, conducting systems-process audits, field audits (e.g. vendors, sites, central IRBs, CROs, CSV), clinical development quality systems (SOP Administration, SOP development, business process development and deployment, process improvements), clinical development training departments and training programs to support infrastructure and regulatory compliance requirements including global regulatory agency inspection readiness.

An integral component of our experience includes supporting both US FDA and MHRA regulatory agency inspections for both medium-sized and large-sized organizations.