Drug development efficiency is a critical consideration for clinical trial sponsors, who face the challenge of beating the odds to get their drug to market: about 90% of drugs fail to pass through clinical development, a lengthy process that involves significant risk and costs.
In most cases, trials fail due to a lack of efficacy or safety. But efficiency of the drug development process itself has a major impact. From end to end, drug development can cost $2.5 billion, and lack of funding has been reported as the reason for failure in more than one-fifth of cases. Sponsors are under pressure to run a clinical trial with often limited funding, which increases their risk of failure.
For small biotech and pharma companies, this pressure is even greater: they often have less room to maneuver when it comes to budgets and staffing, and this can mean the premature end to drug development. To mitigate this risk, sponsors are seeking flexibility in their agreements with suppliers, particularly CROs. The recent upward trend in the Functional Service Provider (FSP) model reflects this.
What Is FSP in Drug Development?
FSP is not a new approach to the CRO–sponsor partnership, but it is gaining ground in the market. The traditional full-service CRO agreement, which involves the CRO taking on all the tasks involved in running the clinical trial, is an effective way for many sponsors to pursue drug development, However, this approach can be costly, making it difficult for many smaller sponsor companies to stay within budget.
As an alternative, the FSP model enables the sponsor to outsource specific functions to the CRO, while retaining control over and responsibility for the clinical trial, including the data generated. The benefits of FSP – such as increased flexibility, cost savings, agility and efficiency – have resulted in a boost to the global FSP market, which is expected to reach a value of US$29.62 bn by 2031.
Many of the benefits of FSP, such as access to expertise, enhanced collaboration and risk mitigation, contribute to greater efficiency of the clinical trial overall.
Increased Flexibility Helps Streamline Processes and Reduce Costs
Unlike the full-service model, which is comparatively rigid in terms of adaptability to unforeseen changes, the FSP model gives sponsors agility. This inherent flexibility means sponsors can adjust the support they get, scaling up or down based on their needs as the trial progresses.
Not only does this save costs, as sponsors only need to pay for the services they need at any given time, but it also helps increase flexibility within the sponsor company. When a biotech or pharma company partners with a CRO on an FSP basis, they can outsource tasks and roles rather than hiring employees in-house, keeping the company small and agile while ensuring thy have the expertise they need.
In addition, in this arrangement, the sponsor company’s infrastructure leads and the CRO integrates into their processes and systems. This is important for maintaining control, and it reduces overheads and unnecessary administration, further reducing costs. By outsourcing in this way, the sponsor optimizes resource use.
Senior Experts Bring Knowledge into Your Team
When a sponsor works with a CRO on an FSP basis, they get the benefit of the CRO’s expertise in three main ways:
- Specialized expertise: the experts the CRO assigns to the sponsor team will bring knowledge of the tasks and responsibilities they are given, such as clinical monitoring
- Therapeutic expertise: whatever role they are covering, experts bring their knowledge and experience of certain therapeutic areas and trial types
- Regulation and compliance: the partnership puts the sponsor in touch with regulation experts at the CRO, supporting compliance and risk management should it be needed
The immediate impact of this on efficiency is that the experts come into the team without the need for lengthy onboarding or training, saving time and money. The tasks and responsibilities – from data management to regulatory submission – are covered from day one.
Longer term, this has a deeper effect on the sponsor organization. Through the process of knowledge transfer, the sponsor’s foundational expertise is strengthened without the need for additional investment.
This is further bolstered by the depth of collaboration FSP supports between the sponsor and CRO. Rather than simply outsourcing the whole trial, the two organizations align on goals and work together closely to achieve them. This has a knock-on impact on subsequent trials, extending the efficiencies through the whole drug development process.
Better Oversight Supports Compliance and Reduces Delays
Compliance-related delays, including at the start-up phase, can be extremely costly. Unfortunately, the regulatory landscape for clinical research is complex, involving an assortment of agencies – international, regional and national – that all have different requirements. Mistakes in regulatory submissions are easy to make, but they can halt a clinical trial for months, driving up costs in the process.
An FSP agreement supports risk mitigation and compliance, helping avoid regulatory delays. The sponsor can bring a compliance expert into the team whenever they need one, helping add extra support to ensure an regulatory submissions and compliance processes run smoothly. And because the relationship is collaborative, the CRO is always a phone call away, providing ad hoc support when needed.
At a fundamental level, the FSP relationship helps ensure compliance by leaving the sponsor in control, with full oversight. Most clinical trial regulations stipulate that the sponsor has ultimate responsibility, regardless of who carries out the tasks and actually runs the trial, so this oversight supports compliance in that way.
Bonus: Agility Lets You Build a Company Around the Trial
The additional speed and agility that an FSP agreement brings to clinical trial operations is conducive to building a company around the trial itself. FSP helps the sponsor keep the organization lean, avoiding the inevitable delays and inefficiencies complex bureaucracy can bring. This in turn enhances agility, as the sponsor can overcome hurdles like recruitment, regulation and protocol changes more easily through efficient decision-making.
With a company built around the clinical trial, supported by an FSP partnership with a CRO, the sponsor benefits from efficiency that extends far beyond the end of the trial itself, into subsequent phases of drug development. Ultimately, it helps bring the intervention to market faster, helping the people who need it.
Harness the Power of FSP to Boost Drug Development Efficiency
At Siron Clinical, we understand the foundational role partnerships have in clinical research. In addition to working with sponsors on a full-service basis, we have offered a broader range of options for outsourcing from the very beginning, including custom FSP solutions.
Today, we offer Customizable Functional Service Provider (FSP) support – 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. This approach helps sponsors stay on track, on time and in control.
Drug development can be complex, but it doesn’t need to be inefficient. Find out how Siron Clinical’s Customizable FSP support can help you succeed with your clinical trial.
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