CLINICAL OPERATIONS STRATEGY
• The fundamental of any successful clinical operation is its structure, people, processes and systems
• People – which competencies are needed?
• Processes – which standards should be defined?
• Systems – how can systems be of help?
GCP COMPLIANCE
• What needs to paid attention to when conducting a clinical trial in a GCP compliant manner, securing both results and quality
• GCP inspection readiness training
• Self-inspections
CLINICAL TRIAL MANAGEMENT SUPPORT
• Support and mentoring clinical trial managers in all aspects of clinical operations
• Project planning, resourcing and budget
• Trial conduct
• People development and training
• Clinical trial risk management