Important Factors for Sponsors to Consider When Outsourcing...
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Important Factors for Sponsors to Consider When Outsourcing Clinical Trials

Pharma Tech Outlook | Friday, April 28, 2023

Outsourcing provides a flexible option for sponsors, allowing them to fully or partially outsource different elements of trials.

FREMONT, CA: Due to the increasing competition in the global clinical research market, small to mid-size pharmaceutical and biotech companies often resort to outsourcing clinical trials to specialist clinical research organisations (CROs) and functional service providers (FSPs) for their expertise, services, and facilities. Collaborating with external experts helps smaller companies tackle significant operational hurdles and achieve successful study delivery, levelling the playing field with larger, well-resourced competitors.

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Why are clinical trials Outsourced?

The competition in the pharmaceutical and biotech industries has grown significantly in recent years, with greater incentives for being the first to market or discovering the next breakthrough drug. Moreover, advances in medical technology have made clinical studies more intricate and extensive.

The heightened competition in the industry has resulted in a greater need for cost-effective clinical trials, and the increased complexity of studies has amplified the demand for specialised expertise in therapeutic and trial management areas. As an example, sponsors can outsource clinical trial management to a contract research organisation (CRO) to control study costs. A full-service CRO partner can leverage their extensive in-house experience across various clinical trials and address the specific challenges of the study more effectively. They can also offer superior site management and risk mitigation capabilities, resulting in potential cost and timeline efficiencies.

Types of Clinical Trial Outsourcing

Contract research organisations (CROs) offer different outsourcing models to cater to the needs of each study. Some studies may only require certain key capabilities, while others may require complete outsourcing services. Regardless, these outsourcing models can enhance operational efficiencies and promote growth for sponsor companies, leading to more cost-effective and timely drug development.

1. Functional Service Provider (FSP)

Functional service providers (FSPs) specialise in offering a singular or a limited number of clinical functions to support a study, such as clinical data management or central laboratory services. The CRO provides the required personnel and facilities to perform specific tasks on a contractual basis, with the staff following the sponsor's procedures. This model is beneficial for smaller biotech and pharmaceutical companies, as it allows access to specialised services on a case-by-case basis and eliminates the need for in-house recruitment of personnel for these specific roles.

2. Full-Service Outsourcing (FSO)

Full-service outsourcing (FSO) refers to outsourcing all or most of the clinical development tasks to a CRO. This means that the CRO handles the entire trial management and delivery process, which is beneficial for sponsors who lack the capacity, facilities, or expertise to carry out the project themselves. Entrusting the entire project to a single provider can also reduce the management workload of the sponsor organisation.

3. Hybrid Model

Hybrid models in clinical trial outsourcing combine aspects of both full-service outsourcing (FSO) and functional service provider (FSP) models. This approach is particularly useful for more complex trials, as it can be tailored to meet the specific needs of each trial component and can adapt as required. For instance, a clinical trial might use a combination of FSO and FSP outsourcing models based on location and logistics, or it might use a mixture of FSO and FSP models across different study phases.

Considerations for Successful Collaboration

To ensure a successful clinical trial, it is crucial to maintain a positive collaboration between sponsors and the clinical research organisation. The following tips can help establish and maintain a good working relationship:

• Establish Clear Expectations Early on: At the beginning of the partnership between a sponsor and a clinical research organisation for a clinical trial, it is crucial to set up clear and precise expectations to ensure that both parties are aligned. This involves defining the roles and responsibilities of each party, establishing timelines, and outlining communication channels.

• Understand Each Other’s Language: Building a strong working relationship between sponsors and CROs requires trust and mutual understanding. This can be achieved by gaining knowledge of each other's language, culture, and processes. Organising introductory sessions can be a useful tool to help internal and external teams develop a positive working relationship.

• Implement a Communication Plan: To ensure a successful clinical trial collaboration between sponsors and CROs, maintaining open and regular communication is crucial. It is important to establish clear communication expectations and develop a centralised communication plan that utilises cloud-based data sharing and secure messaging platforms. Both parties should communicate not only about issues that need to be addressed but also about the progress made and challenges encountered during the study.

• Develop Risk Assessment Plans: In clinical research, it is crucial to conduct risk assessments. Sponsors and CROs should collaborate closely to develop strategies and procedures for risk reduction. This should be a continuous process, with on-site risk assessments being carried out to ensure proper data quality management and risk mitigation throughout the study.

Outsourcing has become increasingly important in clinical research in recent years, as competition in conducting clinical trials has intensified. Contract research organisations have become more essential due to the need for operational efficiency and therapeutic expertise. Outsourcing provides a flexible option for sponsors, allowing them to fully or partially outsource different elements of the trial.

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