Site Management and Monitoring

Over the course of your study project, we are the link between clinical trial sites, sponsors and project partners.

Our Clinical Research Associates (CRAs) provide the following services, among others:

  • Site Initiation Visit (SIV) with protocol training and introduction to the (e)CRF
  • Monitoring Visit (MV) to check that the study has been carried out in accordance with the protocol, including data verification and adequate documentation of undesired events (AEs)
  • Close-out visit (COV)
  • Provision of a summary of each visit in the form of a report
  • Preparation and updating of the investigator site file (ISF)
  • Providing the study sites advice and support on study-specific questions
  • Support of the sponsor by developing documents and information relevant to the study (e.g. worksheets and patient cards)
  • Supporting the trial sites in order to be well prepared for audits

Are you missing a service you require additionally?

Please contact us