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World Clinical Development Outsourcing Models Analysis Report 2021: Model Use and Performance, Outsourcing Model Profiles, Future Trends, & Study Data -

·3-min read

The "Clinical Development Outsourcing Models (4th Edition)" report has been added to's offering.

Trial needs and available resources often direct clinical development activities. Various outsourcing models are available to companies that have trials to conduct and limited or nonexistent in-house resources.

In addition to outsourcing dynamics and new user data regarding hybrid trials, readers will learn model utilization rates overall and by company size, reasons for use, benefits and drawbacks experienced, whether performance expectations were met, and what would prompt a change in outsourcing models. Such comparisons will better inform related outsourcing decisions.

This report takes an in-depth look at seven different clinical development outsourcing models and associated user experiences, based on respondents actively involved in their companies' outsourcing activities:

  • Preferred Provider

  • Fee-For-Service

  • Functional Service Provider (FSP)

  • Hybrid Full-Service and FSP

  • In-Sourced

  • Compound or Program-Based

  • Sole-Source

What You Will Learn:


  • Use the data to compare outsourcing practices and models against industry peers

  • Explore which models are performing better than others

  • Learn advantages and disadvantages to each model

  • Learn why peers have chosen the models they have

Service Providers:

  • Stay on top of the various outsourcing models and sponsor usage

  • Learn the reasons for model selection and where they break down

  • Ensure marketing messages are designed to minimize barriers and improve performance

Major Topics:

  • Clinical Development Outsourcing Dynamics

  • Model Use and Performance

  • Outsourcing Model Profiles

  • Future Trends

  • Study Data

Key Topics Covered:

1. Clinical Development Outsourcing Dynamics

  • Primary Section Takeaways

  • Outsourcing Cost by Function

  • In-House and Outsourcing Model Allocation

  • Preferred Provider Type by Phase

  • Provider Preference by Size

  • Influence Over Provider Selection

2. Model Use and Performance

  • Primary Section Takeaways

  • Outsourcing Models Conducting Clinical

  • Development Work

  • Model Performance Against Expectations

  • Outsourcing Model Performance Scores

  • Benefits of Model Use

  • Drawbacks of Model Use

  • Reasons to Change Models

3. Outsourcing Model Profiles

  • 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

4. Future Trends

  • Primary Section Takeaways

  • Likelihood to Deviate from Current Model

  • Likelihood to Change Providers Based on Trends

  • Hybrid Trial Plans

  • Current vs Future Hybrid Trials

  • Experiences Running Hybrid Trials

  • Downsides to Hybrid Trials

5. Study Data

  • Approaches Used

  • Awareness of Outsourcing Models

  • CRO and Sponsor Organization Preference

  • Compound or Program-Based Outsourcing

  • Current Hybrid Trials

  • Current Level of Outsourcing

  • Current Outsourcing Practices

  • Department-Based FSP

  • Downsides to Hybrid Trials

  • Drawbacks of Use

  • Fee-For-Service Outsourcing

  • Frequency of Use

  • Functional Service Provider (FSP) Outsourcing

  • Future Hybrid Trials

  • Future Trends

  • Geography-Based FSP

  • Hybrid Full Service and FSP Outsourcing

  • Hybrid Trials - What Has Been Frustrating

  • Hybrid Trials - What Has Worked Well

  • Impression of Hybrid Trials

  • In-Sourced Staff

  • Influence on Service Provider Selection

  • Likelihood to Change Providers Based on Trends

  • Likelihood to Deviate from Current Model

  • Location of Personnel

  • Number in Use

  • Outsource Model Compatibility

  • Outsourcing Cost Breakdown by Function

  • Outsourcing and In-house Model Allocation

  • Performance Against Expectations

  • Phase II/III Development Alignment

  • Phase-Based FSP

  • Preferred Provider Outsourcing

  • Proportions by Function

  • Provider Type Preference - Phase I/II

  • Provider Type Preference - Phase III/IV

  • Provider Type for Hybrid Trials

  • Reasons for Not Using Hybrid Trials

  • Reasons for Using Model

  • Reasons to Change Outsourcing Models - Respondent Comments

  • SOP and Technology Use

  • Selection Frequency

  • Sole-Source Outsourcing

  • Therapeutic Area-Based FSP

  • Use of Hybrid Trials

  • Use of Service Provider Type - Phase I/II

  • Use of Service Provider Type - Phase III/IV

  • Variations Used

6. Demographics

  • Company Type

  • Job Level

  • Primary Area of Responsibility

  • Clinical Study Responsibility

  • Knowledge of Outsourcing Models

  • Office Location

For more information about this report visit

View source version on

Laura Wood, Senior Press Manager

For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900