Phase 3 Study Planner
Stage 1: Protocol Development
Creation and finalization of the clinical trial protocol, including study design, endpoints, inclusion/exclusion criteria, and statistical analysis plan
1.1 - Protocol Planning and Team Assembly
Formation of protocol development team and initial planning meetings
1.2 - Protocol Synopsis Development
Creation of high-level protocol outline and key design elements
1.3 - Statistical Analysis Plan Development
Detailed planning of statistical methodology and analyses
1.4 - Full Protocol Writing
Development of complete protocol document with all required sections
1.5 - Case Report Form Development
Design and creation of all study data collection forms
1.6 - Protocol Review and Finalization
Internal and external review process and protocol finalization
1.7 - Data Management Plan Development
Creation of comprehensive plan for data handling and management
Stage 2: Regulatory Submissions
Preparation and submission of regulatory documents to relevant authorities (FDA, EMA, etc.) and obtaining necessary approvals
2.1 - Submission Strategy Development
Development of global regulatory strategy and submission planning
2.2 - Document Preparation - CMC
Preparation of Chemistry, Manufacturing, and Controls documentation
2.3 - Document Preparation - Clinical
Preparation of clinical documentation and summaries
2.4 - Document Preparation - Nonclinical
Preparation of nonclinical documentation and summaries
2.5 - Ethics Committee Submissions
Preparation and submission of documentation to Ethics Committees/IRBs
2.6 - Health Authority Submissions
Compilation and submission of dossiers to regulatory authorities
Stage 2: Regulatory Submissions
Preparation and submission of regulatory documents to relevant authorities (FDA, EMA, etc.) and obtaining necessary approvals
2.1 - Submission Strategy Development
Development of global regulatory strategy and submission planning
2.2 - Document Preparation - CMC
Preparation of Chemistry, Manufacturing, and Controls documentation
2.3 - Document Preparation - Clinical
Preparation of clinical documentation and summaries
Stage 2: Regulatory Submissions
Preparation and submission of regulatory documents to relevant authorities (FDA, EMA, etc.) and obtaining necessary approvals
2.1 - Submission Strategy Development
Development of global regulatory strategy and submission planning
2.2 - Document Preparation - CMC
Preparation of Chemistry, Manufacturing, and Controls documentation
2.3 - Document Preparation - Clinical
Preparation of clinical documentation and summaries
2.4 - Document Preparation - Nonclinical
Preparation of nonclinical documentation and summaries
2.5 - Ethics Committee Submissions
Preparation and submission of documentation to Ethics Committees/IRBs
2.6 - Health Authority Submissions
Compilation and submission of dossiers to regulatory authorities
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