Through clinical monitoring not only the rights and well-being of patients is monitored but also the integrity of the data collected.

Via on-site monitoring, our CRAs ensure that your clinical trial is conducted at the trial sites according to protocol, GCP and all applicable legal and regulatory requirements. At the same time, they are available to site staff for study-specific and/or organizational questions. Thus, our CRAs represent an essential link between the trial sites and you as sponsor and enable targeted communication with your trial sites.

Our range of services includes:

• Individual agreement on the appropriate monitoring strategy for your study, based on a study-specific risk assessment
• Preparation of a study-specific monitoring plan
• Preparation, execution, documentation and follow-up of
  • Qualification Visits
  • Initiation Visits
  • Regular monitoring visits and
  • Close Out Visits
• Support of trial sites in the preparation of audits and inspections
• Professional site management, i.e. our CRAs are the primary contact person for the trial sites for all study-specific issues:
  • Management of confidentiality agreements
  • Obtaining, reviewing, and filing of site specific documents.
  • Conducting regular structured phone calls to monitor study progress at the trial site.
  • Providing telephone guidance to trial site personnel
• Management of the trial site specific part of the TMF at the CTC Cologne