Consulting Services » Product Development » Risk Assessment & Management
Risk Assessment & Management
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Risk Assessment
- Audits of systems; trial-specific audits
- GCP/GLP-audits, ethics issues
- In-house and on-site audits; clinical centers, central laboratories and CROs
- Audits: trial protocols, reports, regulatory files
- Preinspection audits and specific for-cause audits
- Identification of regulatory needs and obligations
- Feasibility and evaluation of protocol in the intended environment
- Identification and evaluation of threats to quality and regulatory compliance of processes, operations, projects, trials and documentation
- International audits of clinical trials (phases I-IV) and research systems at stages of planning, conducting, reporting and submission
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Risk Management
- Creation of standard operating procedure (SOP) management processes and of SOPs
- Evaluation of findings of external audits / inspections
- Resolution plans and recommendations to manage implementation
- Operative support to corrective actions
- Construction of GCP- and GLP-level quality systems and quality operations for clinical development
- Support to maintenance and development of quality standards
- Knowledge on FDA procedures
- Preparation of sites for audits and inspections