Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders. This includes procedures for selection and oversight of CROs and other vendors. Every process – from vendor selection and establishing preferred vendor programs, to study project reports, communication plans, and project escalation – requires a high degree of risk-based diligence to satisfy regulators.
As industry becomes more reliant on outsourcing clinical research activities, outlining clear roles and responsibilities between CRO and sponsor regarding who assesses, monitors, and documents risk management activities is critical to both compliance and study success. Understanding these roles and designing/executing effective risk-based vendor strategies will separate successful firms from those who will fail.
Come to this interactive live session and you will be able to:
- Identify the risk-based study management approaches to CRO oversight
- Recognize areas to assess for gaps in current approaches to CRO selection and oversight related to quality risk management
- Build a risk-based assessment tool for CRO management
- Identify key approaches to planning and preparing to outsource