As resource forecasting for 2021 commences, it is a good time to visit existing resourcing models to ensure they can satisfy the demands of your development pipeline. One model worthy of consideration in a variety of areas is the Functional Sourcing Model (FSP). While FSP is traditionally thought of as applicable to companies with large programs and pipelines, it is increasingly being used by smaller companies who want the same benefits afforded by the FSP model which include: risk mitigation via tighter control over operational processes, consistency, scalability and flexibility in resource management, and cost controls on clinical trial conduct.
With Harbor Clinical’s integrated FSP outsourcing model, sponsors can choose to outsource as much or as little as needed. Some sponsors choose to outsource unique processes within their clinical development programs such as the management of protocol deviations across their programs, medical coding services, eTMF management and maintenance, or larger functions such clinical monitoring and/or data management across their programs to ensure standardization.
Sponsors Maintain Oversight
FSP provides control for sponsors as it requires their specific processes to be followed vs. relying on the full service CROs. In many situations CRO SOPs do not fit within the sponsor environment and FSP provides a tight level of process control enabling tasks to be carried out using the sponsors’ methodology and approach.
Flexibility in Scale
Further, FSP provides consistency and scalability in the resourcing process. Sponsors can quickly ramp up resources or scale down given the nature of their pipeline. Assigned resources stay with programs and sponsors as a key tenant of the model which ensures resource assignment consistency. FSP also takes the uncertainty of resource assignments off the table as sponsors do not need to settle for the B or C team from a CRO as the FSP approach inherently provides flexibility and the right fit in resource selection. This model also provides sponsors separation from employee management, as this lies with the FSP provider, allowing the sponsor to focus on study conduct and oversight.
Given the constant scope creep and change orders seen in full-service outsourcing, FSP provides sponsors relief by enabling cost controls in clinical trials. Through the resource forecasting process, resources are aligned to the needs of the program and rebalanced as needed. Change orders for small scope changes are not seen in the FSP approach which provide stability in forecasting and less time in uncomfortable budget discussions with the CRO. Additionally, rebalancing of resources comes without the additional cost of recruitment or downsizing costs if full time staff were utilized. Further cost controls on clinical trials can be implemented with the FSP approach by choosing services that can be conducted in low cost countries for applicable functions.
Fractional Sourcing for Maximum Flexibility
As mentioned above, smaller companies are also benefiting from FSP as fractional resources are being used to provide these companies similar benefits. Using fractional resources (less than one FTE), sponsors can still have the dedicated support they need in a variety of functional areas without the dependency on a full service CRO. In these projects, part of the effort is spent on process development (if needed) and subsequently on implementation. These fractional FSP resources can also provide vendor oversight in a mixed model approach with full service CROs to meet ICH GCP E6 R2 objectives in the respective functional area.
As illustrated above FSP is not a one size fits approach and provides flexibility in its implementation for all sizes of companies. This model, as implemented by Harbor Clinical, will ensure your clinical development goals are met with unparalleled quality in deliverables, compliance to regulations such as ICH GCP E6 R2, and adherence to your budget.