Clinical Research - Non-Interventional-clinical-studies

  • Post Marketing Surveillance Studies
  • Post Authorization Safety Studies-PASS
  • Epidemiological Studies
  • Observation Studies
  • Pharmacoeconomic Studies
  • ISS studies
 

Services:

  • Feasibilities
  • Site Screening & Selection
  • Site relationship development & continuity
  • Organization of Investigators Meetings
  • Regulatory & IRB Submissions & FU reporting
  • Contracts negotiations, preparation & full execution
  • Study Files Preparation, Maintenance, Close out
  • On-site and Remote Monitoring visits (pre-study, initiation, interim & close out visits)
  • Co-Monitoring visits
  • On-site coordination
  • Data management (query generation & resolution)
  • Project Management & Clinical Team Coordination
    • The main contact liaison between Creative Clinical Team & Pharmaceutical Company
    • Ensure delivery of set project specific KPIs as agreed upon with Pharmaceutical Company
    • Ensure achievement of key project specific milestones
    • Perform co-monitoring visits as agreed upon with Pharmaceutical Company (at project level/according to Global Study Monitoring Plan, ICH/GCP guidelines)
    • Follow-up on trainings requirements of the clinical team (CRAs, CTAs)
    • Develop Risk Management & Mitigation Plans

Creative Pharma Services is an ISO certified company

HQ: 286 Kifisias Ave., Halandri 152 32, Athens, Greece
Tel:  +30 210 32 59 350
Fax: +30 210 32 59 380
info@creativephs.com