Clinical Development Outsourcing Models (3rd Edition)

Description

ISR’s Clinical Development Outsourcing Models (3rd Edition) takes a look at user experiences with seven different clinical development outsourcing models:

  • Preferred Provider
  • Fee-For-Service
  • FSP
  • Hybrid Full Service and FSP
  • In-Sourced
  • Compound or Program-based
  • Sole-Source

Participants were required to have active roles in outsourcing to be included in this study. The data in this report, therefore, assists users in understanding which models the industry is using and how they compare to each other.

Clinical Development Outsourcing Models

For Sponsors:

  • Sponsors can use the data contained in this report to compare their outsourcing practices and models against industry peers and to see which models are performing better than others. Sponsors can also match up their needs (e.g. resource flexibility vs. a desire for improved service provider relationships/deeper partnerships) to see why peers have chosen the models they have.


For Service Providers:

  • This report will help you keep up-to-date on the various outsourcing models and their use. Use the data to better understand why sponsors are selecting the models they are and where the models break down to help ensure your marketing messages and organizations are designed to minimize these barriers and improve performance.
  • Clinical Development Outsourcing Dynamics
  • Outsourcing Models: Performance, Selection and Use
  • Future Trends
  • Study Data

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Clinical Development Model Sample

Executive Summary

Clinical Development Outsourcing Dynamics

Primary Section Takeaways
Outsourcing Cost Breakdown by Function
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

Primary Section Takeaways
Model Performance Against Expectations
Outsourcing Model Performance Scores
Benefits of Model Use
Drawbacks of Model Use
Preferred Provider Model
Fee-For-Service Model
Functional Service Provider (FSP) Model
Hybrid Full Service and FSP Model
In-Sourced Model
Compound or Program-Based Model
Sole-Source Model

Future Trends

Primary Section Takeaways
Likelihood to Deviate from Current Model
Likelihood to Change Service Providers Based on Trends

Study Data

Current Outsourcing Practices

Current Level of Outsourcing
Outsourcing Cost Breakdown by Function
Reasons to Change Outsourcing Models
Preferred Service Provider Type by Phase
Phase II/III Development Alignment
Roles and Responsibilities that Influence Service Provider Selection
Outsourcing Models Used
In-house and Outsourcing Model Allocation
Outsource Model Compatibility
CRO and Sponsor Organization Preference

Preferred Provider Outsourcing

Reasons for Using Preferred Provider Model
Preferred Provider Model: Frequency of Use
Preferred Provider Model: Performance Against Expectations
Preferred Provider Model: Location of Staff
Preferred Provider Model: Benefits of Use
Preferred Provider Model: Drawbacks of Use
Preferred Provider Model: Selection Frequency
Preferred Provider Model: Number in Use

Fee-For-Service Outsourcing

Reasons for Using Fee-For-Service Model
Fee-For-Service Model: Variations Used
Fee-For-Service Model: Performance Against Expectations
Fee-For-Service Model: Location of Staff
Fee-For-Service Model: Benefits of Use
Fee-For-Service Model: Drawbacks of Use

Functional Service Provider (FSP) Outsourcing

Reasons for Using Functional Service Provider Model
Functional Service Provider Model: Variations Used
Functional Service Provider Model: Performance Against Expectations
Functional Service Provider Model: SOP and Technology Use
Functional Service Provider Model: Location of Staff
Functional Service Provider Model: Benefits to Use
Functional Service Provider Model: Drawbacks to Use
Functional Service Provider Model: Department- Based
Functional Service Provider Model: Therapeutic Area-Based
Functional Service Provider Model: Phase-Based
Functional Service Provider Model: Geography- Based

Hybrid Full Service and FSP Outsourcing

Reasons for Using Hybrid Full Service and FSP Model
Hybrid Full Service and FSP Model: Approaches Used
Hybrid Full Service and FSP Model: Performance Against Expectations
Hybrid Full Service and FSP Model: Technology and SOP Use
Hybrid Full Service and FSP Model: Location of Staff
Hybrid Full Service and FSP Model: Benefits to Use
Hybrid Full Service and FSP Model: Drawbacks to Use

In-Sourced Staff

Reasons for Using In-Sourced Model
In-Sourced Model: Proportions by Function
In-Sourced Model: Performance Against Expectations
In-Sourced Model: Benefits of Use
In-Sourced Model: Drawbacks of Use

Compound or Program-Based Outsourcing

Reasons for Using Compound or Program-Based Model
Compound or Program-Based Model: Frequency of Use
Compound or Program-Based Model: Performance Against Expectations
Compound or Program-Based Model: Location of Staff
Compound or Program-Based Model: Benefits to Use
Compound or Program-Based Model: Drawbacks to Use

Sole-Source Outsourcing

Reasons for Using Sole-Source Model
Sole-Source Model: Technology and SOP Use
Sole-Source Model: Performance Against Expectations
Sole-Source Model: Location of Staff
Sole-Source Model: Benefits to Use
Sole-Source Model: Drawbacks to Use

Future Trends

Likelihood to Deviate from Current Model
Likelihood to Change Service Providers Based on Trends

Demographics

Company Type
Job Title
Primary Area of Responsibility
Clinical Study Responsibility
Knowledge of Company’s Outsourcing Models
Office Location
Years of Experience

Additional information

License

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