Services: Medical Affairs

End-to-End Medical Guidance & Therapeutic Expertise

Services: Medical Affairs

Increasingly complex drug development demands support from medical experts to navigate the challenges. Our medical affairs team provides expert advice at all stages of product development, as well as medical monitoring and medical safety oversight. At Synteract our experienced medical experts provide early and ongoing insight and guidance throughout the project life cycle.  We provide therapeutic expertise across a broad spectrum of indications and in specialty areas such as immunotherapy, gene and cell therapy, pediatrics and rare/orphan disease.  

Our experienced medical experts provide critical advice and strategic medical advice in the following ways:

Advisory

  • Protocol development and study design consultation
  • Contribution to clinical trial documents
  • Investigational product assessment
  • Target disease assessment
  • Individual patients' characteristics
  • Trial design assessment
  • Trial examinations and measurements
  • Collaborate with regulatory affairs
  • Liaise with regulatory agencies

Monitoring

  • Trial logistics
  • Medical guidance/training to study teams and sites
  • Data management interface on safety data

Safety

  • Drug Safety involvement
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