Safety Management

Safety first

Scope International’s safety physicians have the practical medical experience and expertise to ensure that your trial progresses safely. By working closely with your study team and combining our medical monitoring services with data management, we are able to provide you continuously with high-quality safety feedback. We supply a complete range of medical services – monitoring, writing, coding, pharmacovigilance and 24/7 consulting. With our extensive medical know-how, we can also offer scientific advice to support your trial.

Contact us for more information on safety and our medical expertise.

  • Experienced and expert safety physicians
  • Medical monitoring combined with data management for highest safety standards
  • Full range of medical services – monitoring, writing, coding, pharmacovigilance and 24/7 consulting
  • Medical expertise to support your study and goals

Always vigilant with your product safety

Scope International provides full pharmacovigilance services for your study – from serious adverse event management to data reconciliation. Our experts handle all your logging, tracking and reporting requirements for all regulatory authorities and ethics committees to local and international standards.

  • Serious adverse event management (receiving, processing, medical reviewing and narrative writing)
  • Compliance with local and international safety reporting requirements
  • Expedited safety reporting
  • Periodic safety reporting (DSUR and others)
  • Data reconciliation of safety and clinical databases
  • Master safety database
  • Signal detection

Physician-lead medical monitoring

With our extensive medical experience, we can help you resolve trial-related medical issues. From setting up medical protocols and providing training to offering 24/7 medical support and data management, Scope International covers all your medical monitoring requirements and more. Our proactive approach enables us to identify potential issues and prepare accordingly, thereby reducing risks, timelines and costs.

  • Resolution of trial-related medical issues
  • Clinical research associate (CRA) and investigator pre-trial training
  • 24/7 trial team medical support with emergency unblinding
  • Laboratory and investigational alert management
  • Medical-term coding

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