Service Description

1. Introduction and Objectives Review and refine the clinical trial budget. Evaluate the proposal for completeness and feasibility. Identify potential risks and mitigation strategies. Ensure alignment with regulatory requirements and best practices. 2. Review of the Clinical Trial Proposal Study Overview: Summary of the trial's purpose, hypothesis, and objectives. Design and Methodology: Description of the study design, including: Patient population. Inclusion and exclusion criteria. Study endpoints. Statistical methods. 3. Budget Review Budget Breakdown: Detailed review of the budget components: Personnel costs. Study site costs. Participant recruitment and retention. Data management and analysis. Regulatory and ethical approvals. Contingency funds. Cost Justifications: Discuss and validate the cost estimates for each budget component. Budget Alignment with Proposal: Ensure that the budget is aligned with the study design and methodology. 4. Proposal Review Regulatory Compliance: Confirm that the proposal meets all regulatory requirements (e.g., IRB approval, informed consent). Feasibility Assessment: Evaluate the feasibility of the study design, considering: Recruitment strategies. Study timelines. Resource availability. Risk Assessment: Identify potential risks and discuss mitigation strategies. 5. Q&A and Open Discussion Address any questions or concerns from the team. Discuss any additional suggestions for improving the proposal and budget. 6. Action Items and Next Steps Summary of Key Points: Recap the main points discussed during the session. Action Items: Assign specific tasks to team members with clear deadlines. Follow-Up Meeting: Schedule a follow-up meeting to review progress and address any outstanding issues.