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Clinical Research – Pharmaceuticals & MD

Pharmaceuticals

✿ Strategic Plan
✿ Cinical Trial Application
✿ Ethical Committee Application
✿ Identification of Sites
✿ Study Initiation
✿ Monitoring
✿ Study Closure
✿ ICF, eICF, Inclusion/Exclusion Criteria
✿ CRF Design
✿ Investigation Brochure – IB

MD

✿ Clinical Study Plan, Protocol and Report
✿ Data Management- SAS Programming
✿ Data Entry & Data Analysis
✿ Clinical Event Adjudication
✿ Statistical Analysis
✿ Project Administration/Management
✿ Literature Studies, Clinical Investigational Plan, Clinical Evidence
✿ Clinical Evaluation Plan and Report for Medical Devices