Site Monitoring

Clinical trials ensure a product is safe and effective for human use. These trials are necessary to gain approval to sell certain products in the U.S. market.

Regulatory Specialists has coordinated numerous clinical studies within the United States and throughout the world. We provide clinical site monitoring as well as many other services necessary to ensure compliance with clinical study regulations.

Clinical study sites are required to be monitored. Regulatory Specialists provides four types of monitoring visits:

  1. Preparatory visits before the study begins
  2. Visits at the beginning of the trial to make sure the study starts out according to protocol
  3. Periodic monitoring during the trial
  4. A close-out visit to verify all documentation has been completed according to the protocol

Regulatory Specialists also provides a host of other clinical trial services, including:

  • Protocol preparation
  • Case report forms (CRFs)
  • Statistical design
  • Investigator identification
  • IRB approvals
  • IDE approvals with the FDA
  • Investigator training
  • Interim and final reporting
  • Statistical reviews of data
  • Reports for FDA submission
  • Clinical trial audits