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- Consulting
- Product evaluation and strategy
- Organization of external consultant meetings
- Regulatory submissions to FDA and IRBs
- Study Start-Up
- Protocol development
- Feasibility studies
- Identification and recruitment of qualified study sites and investigators
- Review and negotiation of study budgets and research agreements
- Regulatory document collection and tracking
- Monitoring
- Clinical site monitoring and data collection
- Good Clinical Practice site compliance
- Data Management
- Case report form design
- Database creation and validation
- Adverse event and medication coding
- Project Management
- Customized tracking of patient and site status
- Investigator meetings
- Statistical Analysis
- Organization and oversight of Data Safety Monitoring Boards
- SAP generation and execution
- Medical Writing
- Medical writing of protocols, regulatory applications, study reports, and publications
- Report Submissions
- Investigational New Drug submissions
- Institutional Review Board submissions and regulatory document tracking
- Quality Assurance
- Clinical site audits
- Database, report and file audits
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