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Relevant Research Capabilities and Experience
DCU has provided clinical research support services for over 30 clinical studies and has functioned as the coordinating
center for a number of federally and industry funded projects. DCU study teams provide study design, protocol development,
study form development, data management, quality assurance, information technology, reporting and publications.
| Comprehensive Services |
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1. Collaborative Development of Study Protocols and grants (in conjunction with the CU)
- Review of Literature and Clinical Background
- Study Design Development
- Definition of Study Objectives and Endpoints
- Sample Size Determination
- Randomization Methods
- Statistical Analysis Methodologies
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2. Collaborative Development of Case Report Forms
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3. Development of Study Database
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4. Development of Randomization Scheme and Procedure
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5. Data Management and Data Collection
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6. Liaison to members of the Data and Safety Monitoring Committee
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7. Generation of Reports
- Study Progress Reports
- Data and Safety Monitoring Reports
- FDA Statistical Reports
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8. Collaborative Development of Oral and Poster Presentations
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9. Collaborative Participation in Manuscript Preparation
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