Managing Outsourced Clinical Trials
Overview
Successful product development companies not only have the right systems in place to take advantage of scientific breakthroughs, but also have the right environment in place to support operational and quality management of their clinical research projects. There are rarely clinical trials where other vendors such as contract research organizations (CROs), electronic data capturing (EDC) companies, imaging or specialty laboratories are not required. Knowing when to rely on in-house capabilities and when to take advantage of skills that exist externally can go a long way to expediting development by allowing biopharmaceutical companies to concentrate on their core competencies. Managing these diverse and multidisciplinary groups can become overwhelming for even a seasoned clinical trial manager. This course introduces participants to the selection, oversight and management of clinical trial vendors of all types and includes hands-on exercises and case studies to apply the concepts taught in the materials. In this way, participants may immediately use their new skills back on the job.
Who will benefit
This course will be beneficial to those who have some clinical trial management experience, but who may be faced with their first multi-vendor or global program, such as clinical trial managers, clinical project managers, study managers and clinical program managers.
Key topics
- Regulatory Implications of Outsourcing Clinical Trials
- Planning: Getting the Best Vendor for the Outsourced Project
- Selection and Delegation: Final Selection, Negotiation and Kick-off
- Oversight of the Vendor
- Oversight: Project Communication and Setting Expectations
- Controlling Project Costs
- Oversight: Managing Risk
- Ongoing Project Oversight and Facilitation
- Leadership: The People Side of Study Management
Learning outcomes
- Explain the regulatory implications of outsourcing
- Describe the steps and main tasks of vendor selection
- Illustrate how to build an effective Sponsor-Vendor team
- Describe how planned communication leads to effective vendor oversight
- Build a budget process that helps manage outsourcing and project costs
- Identify and manage project risks
- Utilize leader skills to influence your team
Click here to learn more about bringing this course in-house.