By Aiden Flynn, Exploristics CEO
Functional service provision can help to buffer the continuous ebb and flow of development pipelines for large drug developers. However, the best FSP offerings can also support the development needs of much smaller organisations. So, what are the benefits and what sort of FSP models should you be looking out for?
The Benefits
The right Functional Service Provision (FSP) model offers a responsive, cost-effective scalable resource that enables Sponsors to bring in biostatistics expertise as required to suit their development pipeline needs and accelerate trial timelines. From a trusted provider, it ensures access to right people at the right time with the right skillset and experience to meet the demands of ever-changing study workloads. With the right model, drug developers can benefit from:
- Flexible budget and resource allocation.
- Rapid integration of relevant external expertise, boosting productivity.
- Reduced operational costs and time spent recruiting specialist staff.
- Retaining control of study data and execution.
- Mitigation of study execution risks with work that meets regulatory requirements and industry best practices.
A Highly Flexible Model
Developers are often looking for key expertise, but flexibility is also extremely valuable when it comes to managing fluctuating workloads and limited budgets, particularly if your pipeline is small. At Exploristics, we offer an exceptionally flexible FSP model that ensures fast and easy access to experienced and knowledgeable statisticians and programmers. It saves development time and costs by ensuring suitable additional support can be applied just where and when needed. Our FSP staff have in-depth experience across a broad range of biostatistics services, and can support many study types including:
- Phase I-IV Clinical Trials
- Precision Medicine Studies and Biomarker Discovery and Development
- Real World Evidence Generation
- Translational/Experimental Medicine and Exploratory, hypothesis generating studies.
With programmers qualified to BSc level and above and statisticians to MSc and above, our FSP staff can fill a variety of leading or supporting roles and can join projects at any stage for short- or long-term agreements.
Closely Tailored FSP Solutions
The best fit can often be a bespoke one and it is frequently the most cost-effective overall. Exploristics has a long track record in offering FSP and so understand that every Sponsor has a unique set of requirements. Therefore, we offer closely tailored FSP solutions that can cater to an individual Sponsor’s needs. This can range from delivering support for large Pharma needing niche or additional expertise for an established Statistics team to providing core biostatistics for smaller Biotech with limited or no internal resource at all. Whatever the budget, we can work with you to deliver statistical support that is a good fit and provides the experience and skillset needed for specific project requirements.
Fixed, Full-time or Fractional Models
It is important to consider all the options available to make sure that the model you choose can deliver both the expertise you require and meet the size of your needs. The dedicated on-demand statistical services we provide ensures Sponsors meet project deadlines by assisting with day-to-day requirements such as statistical analysis, data programming and reporting, alleviating workload pressures while ensuring timely and accurate outputs. These capabilities are available via a range of fixed and flexible support models including:
- Fixed or flexible, FTE-FSP Services
- Pay as you go Services (pay per time)
- Access to SaaS (Software as a Service) licensing options for KerusCloud software/Intellectual Property
Unlike many FSP providers, Exploristics offers fractional sourcing where part-time team members can be deployed as needed in a flexible way. This can make sense for companies with smaller development pipelines looking to make the most of more limited budgets.
Services Provided
When selecting an FSP partner it is vital to make sure they have the right expertise and can work to the standards you require. Partnering with Exploristics delivers first-class biostatistics expertise that maintains the highest standards of quality and compliance for your clinical studies, supported by our standard operating procedures (SOPs). Working as an internal member of a project team, we commonly provide services such as:
- Strategic statistical input into clinical development plans.
- Clinical study design optimisation and support for investment.
- Systematic review and collation of historical data/information to inform design options.
- Regulatory support including attending meetings.
- Input into protocols, authorship of statistical documents e.g. SAP.
- Statistical review of data management documents.
- Statistical support for study reporting and QC
- Ad hoc exploratory analysis
- Support for publications.
Additional support can also be provided for strategic study design using our exclusive proprietary simulation-guided design software KerusCloud.
Working in Partnership
Effective partnerships are built on transparent and responsive communication. Exploristics work in close partnership with Sponsors to help specify their FSP need, select the right staff, start, and support staff placements, survey ongoing project requirements and shift provision to ensure the best outcome. It is important to us that any staff we place integrate well into the study teams they join and can hit the ground running. Therefore, we provide them with any additional training that might be required before joining a study, increasing efficiency and saving time. As your FSP partner we offer not only the benefits of continuity through the staff we place but also the technical knowledge, skills, and peer-review from our wider statistical team. This highly flexible and cost-effective resource means that developers of any size can be confident we can deliver the right FSP solution for them to meet their individual project needs.
To find out more about our tailored FSP solutions, book a call with us today.
Read more:
Navigating the complexities of CRO oversight
FSP Case study: Supporting a vaccine clinical trial