Medical and Regulatory Support

Subject Safety First

Patient rights, welfare and safety are of primary importance in the process of conducting clinical trials. ClinPros collaborates with established strategic partners for pharmacovigilance and medical monitoring services to meet your medical safety service requirements. For subject protection as well as data integrity, our project team members review patient safety data throughout the trial through Adverse Event (AE)/Serious Adverse Event (SAE) or Adverse Device Event (ADE)/Serious Adverse Device Effect (SADE) monitoring and review of endpoint data. Our team is equipped to analyze safety data and write Development Safety Update Reports (DSUR), updated clinical investigator brochures (IB), and patient safety narratives, as well as expedited safety reporting to regulatory agencies and distribution of IND Safety Reports or Suspected Unexpected Serious Adverse Reactions (SUSAR) to investigative sites.