Clinical Development Outsourcing Models (2nd edition)

Clinical Development Outsourcing Models (2nd edition)

  • October 2015 •
  • 82 pages •
  • Report ID: 3783203 •
  • Format: PDF
Report Overview

Most pharma companies no longer outsource simply because they have to Most now recognize value in the use of contract organizations But while the evolution of pharma’s outsourcing philosophy has been
fairly uniform across companies, the application of outsourcing strategy remains highly diverse The real trick for a head of R&D is identifying which model is best given the particular pharma company’s culture,
infrastructure for clinical trial management, infrastructure for CRO management, depth of pipeline, and a host of other factors

Methodology:

ISR surveyed 107 respondents who:

• Currently work at a pharma or biotech company with annual R&D expenditure of at least $100M
• Have responsibility for outsourcing clinical trials
• Are somewhat to highly knowledgeable about their company’s clinical development outsourcing model

Report Structure:

Executive Summary

Clinical Development Outsourcing Dynamics
• Outsourcing Cost Breakdown by Function
• Outsourcing Difficulties
• In-House and Outsourcing Model Allocation
• Preferred Service Provider Type by Phase
• Roles and Responsibilities that Influence Service Provider Selection
Outsourcing Models: Performance, Selection, and Use
• Analysis of each outsourcing model evaluated including model performance and reasons for use
Future Trends
• Likelihood to Deviate from Current Model
• Likelihood to Change Service Providers Based on Trends
Study Data

Outsourcing Models Evaluated:

• Preferred Provider Outsourcing
• In-Sourcing Clinical Development Staff
• Fee-For-Service Outsourcing
• Functional Service Provider (FSP) Outsourcing
• Compound or Program-Based Outsourcing
• Hybrid Full Service and FSP Outsourcing
• Sole-Source Outsourcing

What you will learn in this report:

Benefits for each major outsourcing model

• Percentage of outsourcing volume each model currently represents and predictions for future trends
• Sponsor satisfaction, reasons for selection, and details for how each model is used

How you can use this report:

• For Study Sponsors: Pharma buyers of this report are encouraged to use its content to navigate the benefits and drawbacks of available outsourcing models by examining what’s working and not working for other companies and why
• For Service Providers: Service providers are encouraged to use the report’s content to plan for the rise of some models, the decline of others, identify the drivers of success for these models, and anticipate customers’ need accordingly

Introduction

Outsourcing in the pharmaceutical industry is no longer in its infancy The past 25 years have witnessed an evolution in pharma R&D management strategy Outsourcing penetration for development activities now stands at >60% Most pharma companies no longer outsource simply because they have to Most now recognize value in the use of contract organizations Sure, many individuals still hold strong preferences for using in-house resources to run clinical trials, but these attitudes tend to reside deep within operational functions; much less within executive management where R&D strategies are formed Additionally, where outsourcing once was limited to the buying of “hands and feet” – supplemental resources – organizations now regularly purchase experience and guidance (they still don’t like the word “strategy”)

But while the evolution of pharma’s outsourcing philosophy has been fairly uniform across companies, the application of outsourcing strategy remains highly diverse Many approaches to the use of CROs remain in play for those responsible for R&D strategy

The most common among them include:

preferred provider agreements, one-off fee-for-service agreements, functional service provider agreements, large scale single-source partnerships, and a few others of merit
ISR’s data in the current report show – in our judgment – acceptable levels of satisfaction for most outsourcing models The real trick for a head of R&D is not identifying which model is best, but rather, which model is best given the particular pharma company’s culture, infrastructure for clinical trial management, infrastructure for CRO management, depth of pipeline, and a host of other factors

Pharma buyers of this report are encouraged to use its content to navigate the benefits and drawbacks of available outsourcing models by examining what’s working and not working for other companies and why
Service providers are encouraged to use the report’s content to plan for the rise of some models, the decline of others, identify the drivers of success for these models, and anticipate customers’ need accordingly