Clinical Monitoring

Dedicated staff

We allocate a team dedicated to a specific study for the whole duration of that study. In-house backing is available through an in-house management and support team. Our comprehensive SOPs meet the requirements of the European Good Clinical Practice (GCP) Guidelines, Directive 2001/20/EC and Directive 2005/28/ED; the Code of Federal Regulations of the FDA and the Declaration of Helsinki. Inspection readiness is part of our routine monitoring standard. In case of preference to work in accordance with customer’s SOPs, SIRON has the flexibility to adapt to these.

Clinical Monitoring Services:

  • Site identification
  • Feasibility visits
  • Site qualification and initiation
  • Regulatory document preparation and collection
  • Budget and contract negotiation
  • Site recruitment strategy
  • Site personnel training
  • Interim site monitoring
  • Initiation and management of CAPA
  • Accountability investigational material(s)
  • Study closure
  • Pharmacovigilance: assisting and ensuring appropriate reporting of CIOMS, DSURs, annual IDB updates