Clinical Outsourcing: Department Models and Structures

Report Overview

This research looks at the internal struggles and opportunities clinical outsourcing departments face on a daily basis. This research has broad applicability for clinical outsourcing departments at sponsor organizations of any size. These findings will help outsourcing departments understand what other peer organizations are facing, have faced, and will face. For service providers, this research will shed some much needed light onto what is important to these departments and what internal motivations are at work.

ISR interviewed 12 high-level clinical development outsourcing decision-makers via a structured 45-minute telephone conversation. After reviewing the interviews, ISR decided to structure this report by creating 12 case studies as well as rolling the findings into our Executive Summary. We think the case study approach will be extremely valuable as it ensures that response nuances are fully captured.

What you will learn:

• Outsourcing department operations and structuring, including:
• Departmental challenges, as well as best practices for overcoming these challenges
  • How the department is evaluated within the organization
  • Roles/departments involved in service provider selection
  • Size of the outsourcing department
  • Future predictions for the department
• Outsourcing department goals and priorities, including strategies for overcoming challenges and predictions for future changes
• Best practices for: outsourcing department evaluation; departmental structure, resources, and budget; outsourcing models and decision-making

How you can use this report:

• Determine where your company’s approach to clinical outsourcing may be different from a typical industry approach and the benefits and drawbacks that may result.
• Gather information on unique outsourcing department structures or philosophies employed by other organizations.
• Compare your company’s approach to clinical outsourcing against those of other companies.