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Clinical Development Outsourcing Models (4th Edition)

  • ID: 5308977
  • Report
  • March 2021
  • Region: Global
  • 144 Pages
  • Industry Standard Research (ISR)
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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. 

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

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.

What You Will Learn:

Sponsors:

  • 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
Note: Product cover images may vary from those shown
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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

  • Current Outsourcing Practices
  • Current Level of Outsourcing
  • Outsourcing Cost Breakdown by Function
  • Use of Service Provider Type - Phase I/II
  • Use of Service Provider Type - Phase III/IV
  • Provider Type Preference - Phase I/II
  • Provider Type Preference - Phase III/IV
  • Phase II/III Development Alignment
  • Influence on Service Provider Selection
  • Awareness of Outsourcing Models
  • Outsourcing and In-house Model Allocation
  • Outsource Model Compatibility
  • CRO and Sponsor Organization Preference
  • Reasons to Change Outsourcing Models - Respondent Comments
  • Preferred Provider Outsourcing
  • Reasons for Using Model
  • Frequency of Use
  • Performance Against Expectations
  • Location of Personnel
  • Benefits of Use
  • Drawbacks of Use
  • Selection Frequency
  • Number in Use
  • Fee-For-Service Outsourcing
  • Reasons for Using Model
  • Variations Used
  • Performance Against Expectations
  • Location of Personnel
  • Benefits of Use
  • Drawbacks of Use
  • Functional Service Provider (FSP) Outsourcing
  • Reasons for Using Model
  • Variations Used
  • Performance Against Expectations
  • SOP and Technology Use
  • Location of Personnel
  • Benefits of Use
  • Drawbacks of Use
  • Department-Based FSP
  • Therapeutic Area-Based FSP
  • Phase-Based FSP
  • Geography-Based FSP
  • Hybrid Full Service and FSP Outsourcing
  • Reasons for Using Model
  • Approaches Used
  • Performance Against Expectations
  • SOP and Technology Use
  • Location of Personnel
  • Benefits of Use
  • Drawbacks of Use
  • In-Sourced Staff
  • Reasons for Using Model
  • Proportions by Function
  • Performance Against Expectations
  • Benefits of Use
  • Drawbacks of Use
  • Compound or Program-Based Outsourcing
  • Reasons for Using Model
  • Frequency of Use
  • Performance Against Expectations
  • Location of Personnel
  • Benefits of Use
  • Drawbacks of Use
  • Sole-Source Outsourcing
  • Reasons for Using Model
  • SOP and Technology Use
  • Performance Against Expectations
  • Location of Personnel
  • Benefits of Use
  • Drawbacks of Use
  • Future Trends
  • Likelihood to Deviate from Current Model
  • Likelihood to Change Providers Based on Trends
  • Use of Hybrid Trials
  • Reasons for Not Using Hybrid Trials
  • Hybrid Trials - What Has Worked Well
  • Hybrid Trials - What Has Been Frustrating
  • Provider Type for Hybrid Trials
  • Current Hybrid Trials
  • Future Hybrid Trials
  • Impression of Hybrid Trials
  • Downsides to Hybrid Trials

6. Demographics

  • Company Type
  • Job Level
  • Primary Area of Responsibility
  • Clinical Study Responsibility
  • Knowledge of Outsourcing Models
  • Office Location
Note: Product cover images may vary from those shown
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