Clinical Study Project Management

CVO-EUROPE assists and supports you in the setup and monitoring of local clinical trials.

 

Our offer

Study Setup

  • File preparation for submission to various appropriate authorities
  • Study Documentation
  • Identification of market areas, Feasibility Studies
  • Management of contracts and various documents with researchers
  • Management of agreements with healthcare establishments
  • Preselecting Visits
  • Training clinical research associates (CRAs) in protocols and pathology
  • Investigators Reunion
  • Setup of study specific SOPs

 

Study Monitoring

  • Coordination and monitoring of study and internal procedure regulatory aspects
  • Administrative and logistic monitoring of studies
  • Study Budget Monitoring
  • Reexamination and validation of ARC visit monitoring reports
  • Monitoring of patient recruitment
  • Onsite visit support
  • Tracking of undesirable effects, issues and other events
  • Monitoring of amendments and tracking protocol deviations

 

Study Completion

  • Reexamination and validation of CRFs(Case Report Forms) and other documents
  • Data correction if applicable
  • Monitoring of post study visits with certain patients
  • Research center closing visit

 

Training

  • B26 - Good clinical practices in drug trials: Quality and ethical data
  • A11 - Information System Validation

 
Auditing

  • BPC/GCP ICHE6 Quality system compliance auditing
  • Trial protocol auditing
  • Trial report auditing
  • Supplier auditing: Laboratories, systems, hosting
  • Selection, qualification site: CRO, healthcare centers (hospitals, clinics…)
  • Computerized systems auditing
  • FDA Mock Inspection and site preparation