Clinical Development Outsourcing Models (4th Edition)

Description

Trial needs and available resources often direct clinical development activities. Various outsourcing models are available to companies who 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:

  1. Preferred Provider
  2. Fee-For-Service
  3. Functional Service Provider (FSP)
  4. Hybrid Full-Service and FSP
  5. In-Sourced
  6. Compound or Program-Based
  7. 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.

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
  • Clinical Development Outsourcing Dynamics
  • Model Use and Performance
  • Outsourcing Model Profiles
  • Future Trends
  • Study Data

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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

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

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

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

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

Demographics

Company Type
Job Level
Primary Area of Responsibility
Clinical Study Responsibility
Knowledge of Outsourcing Models
Office Location

Additional information

License

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