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Overview of Typical Tasks and Deliverables : |
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Clinical Research |
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Clinical trial management |
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Patient Recruitment and Retention |
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Onsite monitoring |
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Final data review and preparation of clinical study reports |
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Pharmacovigilence |
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Data Management |
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All elements of data flow process (e.g., case report form development, validation checks, data listing review, statistics) |
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Regulatory Documents |
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Strategy |
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Esubmissions |
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Submissions |
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Interactions |
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Medical Writing |
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Investigator Brochure |
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Protocol |
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Case Report Form |
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Patient information leaflets for clinical trials and package inserts |
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Informed Consent Form |
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Safety data reports |
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Statistical analysis plan |
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Medical translation services |
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Regulatory submissions |
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Final Report |
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