Building a High-Performing Clinical Operations Team: In-House, FSP, or CRO?

The decision to build an internal clinical operations team, partner with a Functional Service Provider (FSP), or outsource to a full-service Contract Research Organization (CRO) is critical for the success of clinical trials. This whitepaper explores the advantages, disadvantages, and key considerations for each model.

In-House Clinical Operations Team

Advantages:

• Complete Control: Sponsors retain full ownership of the clinical trial process, ensuring alignment with strategic goals.
• Intellectual Property Protection: Sensitive data and proprietary information remain within the organization.
• Long-Term Cost Efficiency: Building a skilled internal team can lead to cost savings in the long run.
• Stronger Company Culture: In-house teams contribute to the company's culture and knowledge base.

Disadvantages:

• High Initial Investment: Building and maintaining a skilled team requires significant upfront costs, including recruitment, training, and infrastructure.
• Resource Constraints: Internal teams may lack the capacity to handle peak workloads or specialized expertise.
• Time-to-Market Delays: Building a team takes time, potentially impacting trial timelines.
• Regulatory Compliance Risk: Maintaining compliance with evolving regulations requires ongoing investment in training and systems.

Data:

• A study by Tufts Center for the Study of Drug Development found that the average cost of developing a new drug increased by 15% from 2013 to 2018. Building an in-house team can help mitigate these costs in the long term.
• A survey by PharmaTimes reported that 40% of pharmaceutical companies plan to increase their investment in in-house clinical development capabilities.

Functional Service Provider (FSP)

Advantages:

• Scalability: FSPs can be rapidly scaled up or down to meet project needs.
• Specialized Expertise: FSPs often have deep expertise in specific therapeutic areas or trial phases.
• Cost-Effective: FSPs can offer cost savings compared to building an in-house team, especially for smaller projects.
• Shared Risk: FSPs share some of the project risk with the sponsor.

Disadvantages:

• Less Control: Sponsors have less control over the clinical trial process compared to an in-house team.
• Potential for Vendor Management Challenges: Managing multiple FSPs can be complex.
• Data Security Risks: Sharing sensitive data with an external provider introduces potential security risks.
• Long-Term Costs: While initially cost-effective, long-term FSP relationships may become expensive.

Data:

• A report by IQVIA found that the use of FSPs increased by 20% between 2015 and 2020.
• The average cost savings of using an FSP compared to an in-house team is estimated to be between 10% and 20%.

Full-Service Contract Research Organization (CRO)

Advantages:

• End-to-End Solutions: CROs offer a comprehensive range of services, from study design to data analysis.
• Global Reach: CROs often have a global presence, facilitating international trials.
• Quick Start-Up: CROs can quickly mobilize resources for new trials.
• Risk Mitigation: CROs assume a significant portion of the project risk.

Disadvantages:

• High Costs: CRO services can be expensive, especially for large-scale trials.
• Less Control: Sponsors have limited control over the clinical trial process.
• Potential for Quality Issues: Maintaining consistent quality across CRO projects can be challenging.
• Data Security Concerns: Sharing sensitive data with an external provider introduces risks.

Data:

• The global CRO market size is projected to reach USD 75.5 billion by 2028, according to Grand View Research.
• A study by PharmaTimes found that 60% of pharmaceutical companies use CROs for at least one phase of clinical development.

Key Considerations

• Therapeutic Area: The complexity and regulatory requirements of the therapeutic area will influence the optimal model.
• Trial Phase: Early-phase trials may benefit from an in-house team or FSP, while late-phase trials may require a CRO.
• Budget: Evaluate the upfront and ongoing costs of each option, including resource allocation, infrastructure, and vendor management.
• Expertise: Assess the availability of internal expertise and the need for specialized skills.
• Risk Tolerance: Consider the level of risk the organization is willing to accept.
• Company Culture: Evaluate how each model aligns with the company's culture and strategic goals.

Conclusion

The choice between an in-house team, FSP, or CRO depends on a variety of factors and should be carefully evaluated based on the specific needs of each clinical trial. A hybrid approach, combining elements of different models, may also be considered. Ultimately, the goal is to build a high-performing clinical operations team that delivers efficient and successful trials.