Clinical Safety

Clinical Safety Solutions

ProPharma Group is a leading provider of clinical safety services for pharmaceutical and biotechnology companies across a wide range of therapeutic areas.  We also partner with CROs to provide clinical safety and safety database hosting services to their clients.

We understand the best clinical safety and medical monitoring teams are those that can aid you throughout the course of your study. ProPharma Group’s safety specialists manage Phase I through Phase IV clinical trials. We work closely with sponsors and CROs to develop Safety Management Plans (SMP) and Medical Monitoring Plans to meet the requirements of study protocols.   

ProPharma Group works as a part of your project team to bring you continual and comprehensive support, collaborating with you from start to finish, ensuring that your study meets all regulatory requirements as well as the highest medical and scientific standards.

ProPharma Group offers a wide range of clinical safety services, including:

  • Medical Monitoring
  • Safety Database Hosting
  • Development of Safety Management Plans
  • Processing of SAEs and Other Events of Interest
  • Regulatory Report Submission for SUSARs
  • Line Listing and Summary Tabulation Generation
  • Data Reconciliation
  • Signal Detection
  • Data Safety Monitoring Board Management and Participation
  • Investigator Meetings
  • Audit and Advisory
  • Protocol Development
  • Health Hazard Evaluations