Clinical Development Outsourcing Models (5th Ed.)

Report Overview

Outsourcing has become a crucial component of clinical development programs for many biopharmaceutical companies. The practice allows for increased flexibility in resourcing and enables sponsors to leverage external expertise, access innovative technologies, and gain efficiency. ISR’s Clinical Development Outsourcing Models (5th Edition) report explores three outsourcing models that are commonly used in the clinical trial space:

• Internal + Functional Service Provider (FSP): A sponsor executes some clinical development activities for a study internally but outsources all or most of one or multiple functions (e.g., data management, biostatistics, pharmacovigilance, etc.).
• Fully Outsourced to One Provider: A sponsor outsources all services for a study to a single CRO. The CRO may or may not subcontract to other providers.
• Fully Outsourced to Multiple Providers (best-of-breed/FSP): A sponsor fully outsources the execution of a study but contracts directly with various “best-of- breed” providers to mix and match services for a custom approach to completing a clinical development project.

This report uncovers the unique benefits and drawbacks of each strategy and weighs their fit for purpose. In addition to the three outsourcing models, respondents also provide insight into their use of in-house and in-sourced resources as well as strategic partners and preferred providers.

What you will learn:

Sponsors:

• Benchmark your outsourcing practices and models against industry peers
• Explore the advantages and disadvantages associated with each model
• Discover respondent perceptions of the best and worst outsourcing strategy for a variety of clinical trial scenarios
• Understand how outsourcers employ service providers to meet their needs, including the use of strategic partners and preferred providers

Service Providers:

• Gain insight into sponsors’ outsourcing decisions
• Understand sponsor satisfaction with each outsourcing model
• Discover top drivers for changing outsourcing strategies
• Align your services with predicted trends in the clinical outsourcing space

Major Topics:

• Outsourcing Model Profiles
• Clinical Development Outsourcing Practices
• Outsourcing Model Perceptions and Preferences
• Future Trends
• Study Data
• Demographics