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Clinical Development Outsourcing Models

  • October 2013
  • -
  • Industry Standard Research
  • -
  • 71 pages

ISR’s report explores how often various outsourcing models are used, sponsor satisfaction with models, the driving forces behind using each type of model, as well as which situations would be likely to cause a sponsor to deviate from their standard outsourcing design.

What you will learn in this report:
- Benefits for each major outsourcing model
- Percentage of outsourcing volume each model currently represents and how this will shift by 2015
- Sponsor satisfaction, reasons for selection, and details for how each model is used

How you can use this report:
- For Study Sponsors: Identify which outsourcing models other organizations are utilizing, their level of satisfaction, and their reasons for choosing that model.
- For Service Providers: Define your marketing and operational strategy by understand your customers’ current and future outsourcing needs and why they choose certain outsourcing models.

Table Of Contents

Clinical Development Outsourcing Models
Table of Contents

Copyright and Usage Guidelines 4
Methodology ..5
Executive Summary ..6
Introduction ..6
Clinical Development Outsourcing Dynamics .7
Outsourcing Cost Breakdown by Function .7
Outsourcing Model Drivers 8
In-House and Outsourcing Model Allocation 9
Preferred Service Provider Type by Phase ..10
Outsourcing Difficulties .11
Roles and Responsibilities that Influence Service Provider Selection 12
Satisfaction, Selection, and Use of Outsourcing Models 13
Satisfaction Overview 13
Selection Driver Overview ..14
Fee-For-Service Outsourcing ..15
Preferred Provider Outsourcing 16
Functional Service Provider (FSP) Outsourcing .18
In-Sourcing ..20
Compound or Program-Based 22
Sole-Source .23
Future Predictions ..24
Likelihood to Deviate from Current Model .24
Likelihood to Change Service Providers Based on Trends 25
Study Data ..26
Current Outsourcing Practices ..27
Current Level of Outsourcing .27
Outsourcing Cost Breakdown by Function ..28
Outsourcing Model Drivers .29
Outsourcing Difficulties 30
Preferred Service Provider Type by Phase ..31
Phase II/III Development Alignment ..32
Roles and Responsibilities that Influence Service Provider Selection 33
Outsourcing Models Used 34
In-House and Outsourcing Model Allocation .35
Fee-For-Service Outsourcing ..36
Reasons for Using Fee-For-Service ..36
Fee-For-Service Variations Used ..37
Satisfaction with Fee-For-Service .38
Drivers to Use Fee-For-Service ..39
Preferred Provider Outsourcing 40
Reasons for Using Preferred Provider 40
Preferred Provider Model Use Frequency ..41
Satisfaction with Preferred Provider ..41
Drivers to Use Preferred Provider 42
Preferred Provider Selection Frequency ..43
Number of Preferred Providers 44
Functional Service Provider (FSP) Outsourcing .45
Reasons for Using Functional Service Provider .45
Functional Service Provider Variations Used .46
Satisfaction with Functional Service Provider 47
Drivers to Use Functional Service Provider .48
Department-Based FSP Models 49
Geography-Based FSP Models ..50
Phase-Based FSP Models .51
Therapeutic Area-Based FSP Models .52
In-Sourcing Clinical Development Staff .53
Reasons for In-Sourcing 53
In-Sourcing Proportions by Function .54
Satisfaction with In-Sourcing .55
Drivers to Use In-Sourcing ..56
Compound or Program-Based Outsourcing 57
Reasons for Using Compound or Program-Based 57
Compound or Program-Based Model Use Frequency ..58
Satisfaction with Compound or Program-Based ..58
Drivers to Use Compound or Program-Based 59
Sole-Source Outsourcing ..60
Reasons for Using Sole-Source ..60
Sole-Source Structure 61
Satisfaction with Sole-Source 62
Drivers to Use Sole-Source ..63
Future Predictions 64
Likelihood to Deviate from Current Model .64
Likelihood to Change Service Providers Based on Trends 65
Respondent Demographics .66
Company Type ..66
Job Title .66
Primary Area of Responsibility ..67
Clinical Study Responsibility 68
Knowledge of Company's Outsourcing Models .68
Office Location ..69
Years of Experience .69
Therapeutic Area Responsibilities 70
About Industry Standard Research 71

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