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Clinical Development Outsourcing Models (2nd edition)

  • October 2015
  • -
  • Industry Standard Research
  • -
  • 82 pages

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

Table Of Contents

Clinical Development Outsourcing Models (2nd edition)
Copyright and Usage Guidelines 4
Methodology 5
Executive Summary 6
Clinical Development Outsourcing Dynamics 8
Outsourcing Cost Breakdown by Function 9
Outsourcing Difficulties 10
In-House and Outsourcing Model Allocation 11
Preferred Service Provider Type by Phase 12
Roles and Responsibilities that Influence Service Provider Selection 13
Outsourcing Models: Performance, Selection, and Use 14
Model Performance against Expectations 15
Outsourcing Model Performance Scores 16
Selection Driver Overview 17
Preferred Provider Outsourcing 18
In-Sourcing 19
Fee-For-Service Outsourcing 21
Functional Service Provider (FSP) Outsourcing 22
Compound or Program-Based 23
Hybrid Full Service and FSP Outsourcing 24
Sole-Source 25
Future Trends 26
Likelihood to Deviate from Current Model 27
Likelihood to Change Service Providers Based on Trends 28
Study Data 29
Current Outsourcing Practices 30
Current Level of Outsourcing 30
Outsourcing Cost Breakdown by Function 31
Reasons to Change Outsourcing Models 32
Outsourcing Difficulties 33
Preferred Service Provider Type by Phase 34
Phase II/III Development Alignment 36
Roles and Responsibilities that Influence Service Provider Selection 37
Outsourcing Models Used 38
In-House and Outsourcing Model Allocation 39
Outsource Model Compatibility 40
CRO and Sponsor Organization Preference 41
Preferred Provider Outsourcing 42
Reasons for Using Preferred Provider 42
Preferred Provider Model Use Frequency 43
Preferred Provider Performance against Expectations 43
Drivers to Use Preferred Provider 44
Preferred Provider Selection Frequency 45
Number of Preferred Providers 46
In-Sourcing Clinical Development Staff 47
Reasons for In-Sourcing 47
In-Sourcing Proportions by Function 48
In-Sourcing Performance against Expectations 49
Drivers to Use In-Sourcing 50
Fee-For-Service Outsourcing 51
Reasons for Using Fee-For-Service 51
Fee-For-Service Variations Used 52
Fee-For-Service Performance against Expectations 53
Drivers to Use Fee-For-Service 54
Functional Service Provider (FSP) Outsourcing 55
Reasons for Using Functional Service Provider 55
Functional Service Provider Variations Used 56
Functional Service Provider Performance against Expectations 57
Functional Service Provider SOP and Technology Use 58
Drivers to Use Functional Service Provider 59
Department-Based FSP Models 60
Geography-Based FSP Models 61
Phase-Based FSP Models 62
Therapeutic Area-Based FSP Models 63
Compound or Program-Based Outsourcing 64
Reasons for Using Compound or Program-Based 64
Compound or Program-Based Model Use Frequency 65
Compound or Program-Based Performance against Expectations 65
Drivers to Use Compound or Program-Based 66
Hybrid Full Service and FSP Outsourcing 67
Reasons for Using Hybrid Full Service and FSP 67
Approaches Used for Hybrid Model 68
Hybrid Full Service and FSP Performance against Expectations 69
Hybrid Full Service and FSP Technology and SOP Use 70
Drivers to Use Hybrid Full Service and FSP71
Sole-Source Outsourcing 72
Reasons for Using Sole-Source 72
Sole-Source Technology and SOP Use 73
Sole-Source Performance against Expectations 74
Drivers to Use Sole-Source 75
Future Trends 76
Likelihood to Deviate from Current Model 76
Likelihood to Change Service Providers Based on Trends 77
Respondent Demographics 78
Company Type 78
Job Title 78
Primary Area of Responsibility 79
Clinical Study Responsibility 80
Knowledge of Company's Outsourcing Models 80
Office Location 81
Years of Experience 81
About Industry Standard Research 82

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