By Colin Stanley, president, DOCS
Clinical outsourcing is constantly changing as drug companies seek new ways of working faster, leaner, and to higher standards. This is causing sponsors to reexamine their outsourcing options, consider different models, and challenge traditional approaches.
Traditional outsourcing models are familiar. Full-service models outsource all (or most) functions of an entire project, typically including trial conduct, oversight, data collection, analysis, and reporting. Functional outsourcing (FSP) models outsource an entire function across a portfolio of projects, such as clinical monitoring, data management, or statistics.
More recently, “strategic partnerships” have emerged. These partnerships evolved traditional, full-service models from a tactical, project-focused arrangement, to a relationship and volume-driven approach focused on a drug development portfolio. CROs are invited to take more ownership and risk and are rewarded with higher revenue and greater flexibility in their approach. Many in the industry believed that such partnership models would lead to the demise of functional outsourcing, with the Pfizer move from FSP to strategic outsourcing signaling the beginning of the end for the FSP model.
However, functional outsourcing is enjoying a resurgence in popularity as both an option within strategic partnership arrangements and as a viable option to full-service strategic models. Indeed, there is visible movement toward hybrid FSP models which seek to take the best of both full-service and functional models with a view to building custom solutions on a sponsor-specific basis.
What Determines A Suitable Outsourcing Model For Your Organization?
Functional models tend to appeal to companies that wish to retain a high degree of control over project delivery, while full-service models have appealed to companies that need access to expertise, technology, and leadership.
In fact, the drive to control progress and ensure effective oversight has led many companies to build duplicate internal organizations to oversee the activities of CROs deploying traditional full-service models. When outsourcers agree on outcomes- based measures of success, require significant external support and expertise on key therapeutic areas of regulatory advice, and have a trusted CRO partner, then full-service outsourcing (tactical or strategic partnerships) makes sense. CROs are experts at managing and delivering projects, particularly when they are given the flexibility and autonomy to be innovative, thereby utilizing their internal resources optimally.
But when control and oversight are imperative for the sponsor, internal access to expertise is already available, systems and processes are already in place, and the sponsor seeks a lower-cost solution, functional models can provide the level of resourcing flexibility and efficiency that can best suit the outsourcer. The sponsor can create an extension of its own organization, maintaining control of project management, technology, and all processes related to the trial. A well-functioning FSP operates as a natural extension of the sponsor — the arms and legs, where the heart and mind reside within the sponsor’s organization, thereby eliminating duplication. Scale of portfolio of work will also influence model choice. It likely does not work for either the sponsor or CRO to create functional models (where efficiency comes from scale) for a single outsourced project. Traditional wisdom tended to treat these models as binary, implying (with some exceptions) that clients were FSPs or full-service outsourcers. But increasingly the norms of these models are being challenged.
A Hybrid FSP Approach
Both models outlined have advantages. But what if a sponsor’s requirements are not quite as simplistic or binary? Recent discussions point to a growing wish to utilize the best of both worlds. Some clients want the control, transparency, and flexibility of a functional model, but they also want access to SOPs, technology, and the expertise of a full-service model. They want to pare down costs to reflect a lean, resourcing-focused solution, but they are prepared to layer in the costs associated with technology, process input, and thought leadership. They seek the scalability of FSP combined with the focus of traditional full-service models.
The critical success factor is in the design and support of the hybrid FSP solution. This design requires a solid global CRO infrastructure and a background in FSP delivery. It may also require significant customization. FSPs act as an extension of the sponsor’s organization, so no two FSPs are exactly alike.