Clinical research is an integral aspect of the healthcare industry. It plays a vital role in developing and approving new treatments and drugs. Clinical research organizations (CROs) specialize in providing services to support clinical research activities. One of the most essential services provided by CROs is functional service provision (FSP). This article will discuss FSP, its benefits, and how it is used in clinical research.
Clinical research is a complex and time-consuming process. It involves various activities such as study design, patient recruitment, data collection, and analysis. Clinical research organizations (CROs) provide support services to pharmaceutical, biotech, and medical device companies to carry out these activities. One of the most important services offered by CROs is functional service provision (FSP).
The use of FSP models has become an increasingly popular trend in the biotech industry over the past few years. Many biotech companies seek to maintain greater control over their clinical trial operations while still leveraging the expertise and resources of CROs.
What is Functional Service Provision (FSP)?
Functional service provision (FSP) is a model in which CROs provide specific functional services to support clinical research activities. These services may include biostatistics, data management, medical writing, pharmacovigilance, and clinical monitoring. Unlike full-service outsourcing, FSP is a more targeted approach that allows companies to outsource specific tasks or functions rather than the entire clinical trial.
The specific functions included in an FSP model can vary depending on your needs.
However, some of the common functions included in Biomapas’ FSP portfolio are:
- Clinical trial management
- Data management
- Medical writing
- Regulatory affairs
- Clinical monitoring
- Safety monitoring
- Quality assurance and control
- Project management
- Site management and support
The Evolution of FSP in Clinical Research
The FSP model has evolved over the years as a response to the changing needs of the pharmaceutical and biotech industries. For example, in the past, companies would outsource their entire clinical trial to a single CRO. However, this approach was not always practical, as it did not allow for flexibility or specialization. As a result, the FSP model emerged, allowing companies to outsource specific functions to CROs specializing in those areas with certain advantages like the ones below.
FSP allows companies to reduce costs by outsourcing specific functions rather than the entire clinical trial. This approach allows companies to be more flexible with their budgets and to allocate resources more efficiently.
Expertise and Flexibility
CROs specializing in specific functions have higher expertise and can provide more tailored solutions to their clients. FSP also allows for greater flexibility in clinical trial design and execution.
By outsourcing specific functions to CROs, companies can mitigate risks associated with clinical trial execution. In addition, CROs have specialized expertise in their respective areas and can ensure compliance with regulatory requirements and industry best practices.
Challenges in Implementing FSP
While FSP has many benefits, it is not without its challenges. Some of the common challenges in implementing FSP include.
Communication and Collaboration
Effective communication and collaboration between the CRO and the pharmaceutical company are crucial for the success of FSP. Both parties must establish clear communication channels, set expectations, and provide regular updates on progress.
Integration with Existing Processes
FSP requires close integration with the pharmaceutical company’s existing processes and systems. This can be challenging, mainly when working with multiple CROs that provide different functions.
Selecting a CRO for Functional Service Provision
Selecting the right functional service provision partner is critical for the success of clinical trial outsourcing. Here are some key factors to consider Biomapas when they are selecting an FSP partner:
- Expertise & experience
- Scalability & flexibility
- Cultural fit
- Quality & Compliance
- Communication & reporting
- References & Reputation
Scalable Function Service Provision
The selection and implementation of functional service provision (FSP) models can vary between biotech and big pharma companies. Due to differences in their organizational structures, resources, and outsourcing needs, our experts consider your:
- Organizational structure
- Outsourcing needs
- Risk tolerance
- Collaboration & communication
FSP For Biotech
For small Phase 1 trials, FSP can be an efficient and cost-effective solution to provide the necessary resources and expertise to manage the trial, which may not be available in-house. This allows you to focus on their core business activities while we provide the necessary support to bring your drug candidate closer to market.
FSP For Big Pharma
For large Phase 3 trials, FSP can also be a valuable solution to manage complex trials with sites in multiple countries and regions. Biomapas can provide local project management support and regional expertise to ensure site consistency and coordination. This allows the pharmaceutical company to leverage our expertise and resources to manage the trial effectively while maintaining control over the trial and retaining ownership of the data.
Future of FSP in Clinical Research
FSP is a growing trend in clinical research and is expected to continue gaining popularity in the coming years. As pharmaceutical companies continue to face cost pressures and seek more specialized expertise, FSP will likely become an increasingly important part of the clinical trial landscape.
Functional service provision (FSP) is a targeted approach to outsourcing specific functions in clinical research. FSP offers several advantages, including cost savings, expertise and flexibility, and risk mitigation. While there are challenges in implementing FSP, it is a growing trend in the industry and is expected to become increasingly important in the years to come.
Let’s celebrate success
Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new...
How can a CRO support Mergers & Acquisition
The role of Contract Research Organizations (CROs) in supporting mergers and acquisitions (M&As) is not a new concept, as CROs have been providing services in this area for several years. However, the demand for these services may have increased in recent years...
Clinical Trial Design For Early Phase Oncology Studies
Designing effective early-phase oncology trials is a complex and challenging task, requiring careful consideration of various factors, including patient selection, dosing, safety monitoring, and endpoint selection. In addition, developing targeted therapies has...