Site Management

Through our Excel Clinical Research Division, we provide comprehensive Site Management Organization (SMO) and Investigator & Site Facilitation services. Our focus is to ensure that our Investigator network and enrolled patients represent the diversity we see in society.

The site management processes and procedures of the Excel Clinical Division of EthosExcel are designed to address the Food and Drug Administration Safety and Innovation Act (FDASIA) that was passed in July 2012. Specifically, we help companies address the unique challenges of fulfilling the requirements of sections:

  • Sec. 907. Reporting of inclusion of demographic subgroups in clinical trials and data analysis in applications for drugs, biologics and devices.

  • Sec. 1138. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented sub-populations, including racial subgroups.

Site Management Services Include:

  • Investigator selection, qualification and recruitment

  • Site start-up and training

  • Clinical trial recruitment and enrollment

  • Site regulatory compliance

  • Monitoring and coordination of monitors

  • Management of Adverse-event reporting

  • Investigator and Trial Site Facilitation