Siron Clinical’s FSP Approach

Partnerships are foundational to clinical research, particularly those between the sponsor, such as a biotech or pharmaceutical company, and the contract research organization (CRO), like Siron Clinical. Clinical research outsourcing has typically been on a full-service basis, where the CRO is delegated the tasks and responsibilities necessary to carry out the clinical trial.

However, clinical research is complex and often unpredictable, requiring more flexibility. In addition, the growing prominence of small biotech companies in the clinical trials landscape means full-service contracts are often ill-fitting for the needs of the trial and the sponsor company.

This is where FSP in clinical research comes in. The Functional Service Provider (FSP) model in clinical research, such as Siron Clinical’s FSP, is a more flexible approach to contracting, with customized clinical trial services offered on a functional basis. That is, the sponsor can outsource functions, such as clinical monitoring, to the CRO.

Customized FSP solutions for clinical trials

As a global CRO with almost 25 years of experience across a range of therapeutic areas and trial types, Siron Clinical understands the importance of flexible trial services for the success of clinical research.

In addition to partnering with sponsors as a full-service CRO, Siron Clinical has taken a broader view of clinical research outsourcing from the very beginning, offering custom FSP solutions where needed. Over the years, this has evolved into tailored FSP contracts, designed to support the individual needs of each clinical trial.

FSP in clinical research enables sponsors to focus their resources on critical trial activities, delegating the day-to-day management of specific functions to Siron Clinical while retaining oversight and control of the operations. This is not only beneficial in terms of fulfilling functions but also for strengthening regulatory compliance in clinical trials.

Expertise across therapeutic areas

Central to the success of Siron Clinical’s flexible FSP contracts is the skill of our CRAs and project managers. Each of our CRAs in clinical research has experience of at least 15 years, and their therapeutic expertise has been applied across a range of trial types.

This expertise is highlighted in numerous case studies. For example, in one hepatology study, Siron Clinical provided 15 additional CRAs to accommodate expanding research. As the sponsor stated, “Every one of them came with excellent experience. The quality of their staff assigned to us was excellent.”

With the Siron Clinical Customizable FSP model, sponsors get specialized senior staff with expertise and cross-functional experience to build their in-house team’s capabilities.

Sponsors work directly with our highly experienced CRAs and project managers, rather than having to go through us. And the benefit doesn’t end with the contract: by integrating with the sponsor team, we facilitate knowledge transfer that will benefit the biotech or pharma company long after the trial has ended.

Flexible and scalable contracts

When starting a clinical trial, it can be challenging to find a CRO that is sufficiently adaptable, at the right budget. At Siron Clinical, our flexible FSP contracts provide scalable clinical research solutions that adapt to the growing needs of sponsors.

Our Customizable Functional Service Provider (FSP) support is a flexible hybrid FSP model that allows sponsors to start with selected functions to fit the needs and budget of the trial and eventually expand to full-service CRO capabilities, if needed, without changing personnel.

As a small but global CRO, Siron Clinical is better able to adapt to sponsors’ changing needs, at lower cost and with more flexibility than they may be used to. With our scalable trial services, sponsors decide what support they need and when, and because they pay for the support they get, sponsors have more control over their budget and forecasting.

Optimized resources and cost-effective solutions

In full-service CRO partnerships, sponsors can face unforeseen costs in the form of change orders. This is a challenge that results from delegating the full range of tasks and responsibilities to the CRO, along with the management of any unexpected changes in the research as it progresses.

There are many benefits to this approach, but for startup biotechs and small-scale studies in particular, trial budget management might be a bigger concern. FSP in clinical research offers the clinical trial cost savings many sponsors are looking for, along with the contract flexibility to adjust services during the trial.

Siron Clinical’s cost-efficient FSP services reduce administrative burden on the clinical trial sponsor while optimizing resources, resulting in greater operational efficiency. This is where our smaller size plays a role: we are able to operate with agility and deliver more flexible solutions at lower costs compared to large CROs.

Maintaining trial leadership with expert support

Clinical trial sponsors today must comply with stringent regulatory requirements, including when it comes to oversight of the tasks and activities carried out during the research. Clinical trial oversight can be more difficult to maintain under a full-service CRO agreement, where trial control is largely handed over to the CRO.

In an FSP collaboration, on the other hand, the sponsor retains full control of the clinical trial, including all tasks and responsibilities, and Siron Clinical handles the execution of specific services or functions.

With Siron Clinical’s Customizable FSP option, our experts integrate into the sponsor’s team and infrastructure. In this partnership model, the sponsor gains the benefit of knowledge transfer into their team, while retaining oversight and control of the trial without the need for additional governance.

Regulatory affairs and compliance

Our support of regulatory compliance goes beyond ensuring that sponsors have full oversight of the clinical trial. Siron Clinical ensures strict adherence to regulatory guidelines and ethical standards across all trial functions.

Senior CRAs and project managers at Siron Clinical are experts in the regulations that impact clinical research, including the Clinical Trials Regulation (CTR) in Europe and FDA regulations in the USA. They also work according to the General Data Protection Regulation (GDPR) and adhere to Good Clinical Practice (GCP) guidelines.

In addition to complying with these international and regional clinical trial regulations, our research professionals have local knowledge and experience, ensuring trial integrity at the national level too. With a full understanding of the requirements, and a solid ethical foundation, Siron Clinical ensures sponsors remain compliant throughout the clinical trial process.

Comprehensive monitoring and data verification

Clinical trial data integrity is at the heart of clinical research: data paves the way for a treatment to reach the patients who need it. An FSP partnership can support data integrity through clinical trial monitoring or data management services.

At Siron Clinical, we work with sponsors on an FSP basis to ensure the integrity of their trial data through close oversight. We combine our capabilities in data monitoring with our expertise in clinical trial regulations and guidance to ensure data is compliant. And we understand the importance of sharing results, whatever the outcome.

As with all FSP arrangements, the sponsor is in control: we provide detailed monitoring reports and progress updates to keep sponsors informed and ensure they have the documentation they need to support their control and oversight.

Why Choose Siron Clinical?

With Siron Clinical’s Customizable FSP model, we provide specialist expertise and fulfill specific tasks and functions for every stage of a clinical trial. Our service is flexible and adaptable, and it puts the sponsor in control.

Our Customizable FSP gives sponsors access to senior professionals with broad international expertise across a range of therapeutic areas and trial types. And since we integrate into the sponsor team, they benefit from knowledge transfer without the risk that comes with hiring FTEs.

Are you ready to shape the support you need for your clinical trial? Talk to us about Siron Clinical Customizable FSP.