At SCOPE safety comes first

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SAFETY MANAGEMENT

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

  • Experienced and expert drug 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

For more information on safety and our medical expertise:

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Always vigilant with your product safety

SCOPE provides full drug safety services for your study – from serious adverse event management to data reconciliation and study closure related activities. Our experts proceed with case handling and safety submissions for all regulatory authorities and ethics committees according to local requirements and international standards.

  • Serious adverse event management (receiving, processing, medical reviewing, coding 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
  • Recording in Safety Database
  • Query management and follow-up
  • Signal detection

Physician-led medical monitoring

With our extensive medical experience, we can help to resolve all trial-related medical issues. From setting up medical protocols and providing team training to offering 24/7 medical support and data review, 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