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?