Oncology Clinical Trial Management
- Protocol and CRF design
- Feasibility studies and site selection
- Investigator meetings
- Medical oncology monitoring
- Project management
- Clinical monitoring
- Data management
- Biostatistics
- Medical writing
- Pharmacovigilance
- Regulatory affairs
- Quality assurance
- Drug supply and distribution
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Product Development Consulting
Review of Regulatory Strategy (advice on preclinical and clinical development and rationale)
- Review of CMC (Chemistry Manufacturing & Control) documents
- Application for SME (Small and Medium Enterprise )status
- Orphan Drug Designation- OMPD (Orpham Medicinal Product Designation)
- IMPD (Investigational Medicinal Product Dossier) preparation
- Scientific Advice with National Competent Authority
- Preparation of PIP (Paediatric Investigational Plan)
- Registration Dossier in eCTD
- Protocol Assistance with EMA
- CIR dossier assistance
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