Services

Project and Site Management

 

Project Management Services:

  • Preparation and coordination of all trial-related documentation
  • Supervising of all trial-related procedures
  • Securing timelines with all cooperation partners
  • Coordination of Clinical Trial Submissions at Ethics Commitees and Regulatory Authorities
  • Obtaining regulatory submissions
  • Preparation of monitoring plans, overviewing monitoring activities and reporting
  • Organization and supervision of all trial-related logistical processes including sample shipments
  • Provision Project Status Reports
  • Investigator Meeting organization

Site Management Services:

  • Interaction with clinical sites and investigators
  • Tight communication and reporting to central project management team at headquarters
  • Organization of local team meetings
  • Investigators and site fee negotiation
  • Investigators and sites contract management and finalization
  • Administrative payments to investigators and sites