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

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