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 WritingProject 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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