COURSE DESCRIPTION

OVERVIEW

The ICH E6 GCP update expects that sponsor will provide adequate oversight of a Contract Research Organizations (CROs) when sponsor responsibilities have been transferred for the conduct of a clinical trial. The updated expectations from ICH E6 Addendum come in response to many negative global audit findings related to a lack of vendor oversight.

Risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring inspection readiness.

Typically, defining roles, skill-sets, and setting implementation strategy is critical for vendor oversight. It is essential that sponsors include support for formally including a risk-based and performance management approach to vendor oversight, which will improve the outcomes of the trials, ultimately lending to cost savings.

LEARNING OBJECTIVES

Join us for this 90- minute presentation and be taken through a clinical trial case scenario applying a sponsor oversight plan. Major differences between past best practices and the new guideline will be discussed, along with common pitfalls to avoid.

By joining our interactive session, you will:

• 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.
• Work through a case scenario to learn to identify key approaches to planning and preparing to outsource.