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
HQ: 286 Kifisias Ave., Halandri 152 32, Athens, Greece