Medical And Safety Monitoring

Overview

Advanced Clinical’s Medical and Safety Monitoring team manages the daily medical activities associated with all aspects of your clinical trial. As a full-service CRO, we’re built to support healthcare professionals as they navigate the challenges, risks, and breakthroughs of their study

Other medical and safety monitoring activities include:

  • Communicating with the investigative sites
  • Project-specific and therapeutic-area training to Advanced Clinical team members
  • Review of safety and I/E criteria
  • Fielding medical-related site questions
  • Protocol deviation review and management
  • Oversight of safety in the study and continual evaluation of safety data
  • Medical oversight and evaluation of SAEs
  • Review and development of narratives for SAEs
  • Review of coding and safety data listings and tables

PHARMACOVIGILANCE

Drug safety and risk management are critical components to patient health and progress. We offer flexible services for customized case processing and reporting through the use of a trusted vendor or sponsor’s reporting system. Our risk management activities include trending and signal analyses and benefit and risk analyses.

Advanced Clinical has a deep understanding of safety databases, with comprehensive expertise in ARISg, AERS, ARGUS, and others. Our team averages 10 years of industry experience with all document types and regulatory guidelines.

SAFETY DATABASE EXPERTISE