EBM SERVICES

• Clinical Research Services for: Phase I, II, III, IV, Observational Prospective and Retrospective studies, medical devices, clinical trials conducted for academic purposes.
✓ Feasibility Studies
✓ Ethics Committee and Regulatory Authority Submissions
✓ Import License Application and Custom Clearance
✓ Site Visits:*Site Qualification Visits
*Site Initiation Visits
*Site Monitoring Visits
*Site Closure Visit:✓ Patient Recruitment
✓ Study Design
✓ Medical Writing✓ Project Management✓ Biostatistics, Interim and Final Study Reports
✓ Data Management
✓ Database and Software solutions
✓ Database and Software solutions
✓ Delivery of ICH-GCP and Clinical Research Trainings
✓ Registration and Regulatory Affairs*Marketing Authorizations
✓ Quality Assurance
✓ Investigator meeting organisation (local + interantional)
✓ Finalisation of contact process at related study site
(negatiation + approval)
• Follow- Up Clinical Trial Agreement Negotiation and Approval Process• Outsourcing:
✓ Outsourcing Study Site Coordinators
✓ Outsourcing Study Nurses
✓ Outsourcing Clinical Trials Assistants
✓ Outsourcing Clinical Research Associates
