Clinical Operations


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