FDA Regulatory and Clinical Services for the Medical Technology Industry

Services: Clinical Research Organization

We tailor our full service CRO capabilities to accommodate budget and timeline requirements for small feasibility studies, usability studies, clinical performance or marketing studies, and multicenter pivotal studies to support PMAs. We have experience conducting clinical trials with international companies, with clinical sites in the US, Canada, Brazil, Mexico and the EU. We have also managed Post Market Clinical Followup (PMCF) studies to support CE marking. Our services also include study design, statistical analysis plan creation, and data analysis and reporting.

Clinical Research Organization Services offered by M Squared Associates includes: