Strategies for Effective Management and Oversight of Clinical Outsourcing to Ensure Regulatory Compliance
Overview Vendor Oversight is currently a hot topic as Sponsors and vendors aim to get to grips with what is really required. You don’t want to outsource and then expend multiple resources to manage and oversee your trial. As a vendor you want to get on with the outsourced clinical trial in the most effective way feasible without micromanagement from your sponsor company. What is required to compliantly and efficiently implement vendor oversight? What are the risks and challenges of not getting this right from the beginning? This course will aim to work through some of these challenging topics with time given to work through specific scenarios from the attendees. Areas Covered in the Session Meeting Regulatory Expectations: recent industry and regulatory items that impact Vendor Oversight to include ICH E 6 R2 Outsourcing models: what could work best for your organization Selecting the right providers for your outsourcing model What are the ...