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M.I.T. Consulting Ltd.


Risk Assessment & Management

  • 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
  • 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