Typically, when people talk about a full-service contract research organization (CRO) they mean a group that handles every aspect of a clinical study, supplying the personnel, the systems, and the processes. The sponsor is spared all operational involvement with the full-service model, simply receiving key information at specified intervals. This model works very well for many sponsors, both large and small. Yet some scenarios require alternate models. What if we redefine “full-service” as a CRO that offers choice?
Sponsors may request help with standalone projects that are a subset of a study. They may seek specified consulting expertise that spans multiple studies. And they may find that a functional service provider (FSP) model is the best option for their study.
In an FSP model, a role or function—from clinical personnel to data management or biostatistics—is outsourced, either for a specific study or across multiple studies. The FSP model solves manpower issues while providing targeted expertise and engagement that staffing companies cannot offer. FSP personnel function as an extension of the sponsor’s staff. Assigned FSP team members use the sponsors’ systems and processes, enabling standardization and simplifying data integration. The sponsor gains the functional expertise and headcount they need while retaining control of all aspects of their trial.
Premier’s FSP, full-service, standalone project, and consulting models can be deployed for any study regardless of phase or therapeutic area. The optimal choice simply depends on the sponsor’s needs and preferences.
Which model is right for your study? It depends.
Some sponsors clearly know which operating model they want to use. Others have an idea of how they want to operationalize their study, but not exactly how to implement their vision. Some sponsors have no idea. The answer lies in a balance of oversight, processes, and technology. By asking the right questions, Premier can help guide the decision.
- How much oversight does the sponsor want to have over the clinical trial? For example, do they want day-to-day involvement in how the clinical research associates (CRAs) conduct their visits and when they occur? Or do they just want updates on the data and overall trial progress?
- Does the sponsor want all of the clinical trial personnel working on-site at their facility? Do they want the same people long-term?
- Does the sponsor have the technologies in place to run the trial? A means of electronic data capture? Licenses for trial master file systems? Or do they need an outside source to supply those?
- Does the sponsor have processes to govern the work that’s being conducted?
Of course, the answers to these questions may differ from study to study—and that is all right. There is not one type of study that clearly points to a specific operational model. Ultimately, it is simply a matter of preference.
The FSP model may be right if…
Innovators from top-five pharmaceutical companies to five-man start-ups find value in the FSP model. Their rationales may differ, but the underlying motivator is the same: FSPs leave control with the sponsor. Here are some specific scenarios:
- A company has been running their own trials. The scale is now beyond their ability to run effectively, but they want to remain involved. They choose the FSP model to augment their internal team.
- A company that has been fully outsourcing their studies to a large CRO has become frustrated by the lack of visibility into their data and the progress of the trial. They may choose to continue under the full-service model with a CRO like Premier instead (our e-Premier system has dashboards and data visualization to keep the sponsor connected to their data), or they could take the trial in-house, operationalizing it through an FSP model.
- A company that has been fully outsourcing their clinical trial portfolio to a group of CROs finds that each company uses a different electronic data capture (EDC) system, database design, metrics, and reporting structure—so their data resists standardization. They decide to achieve consistency by using their own EDC system and engaging FSP personnel to build the databases and conduct the clinical trial activities under the umbrella of a single set of standards.
- A company has a small team, nowhere near the manpower needed to monitor all their clinical trial sites, but they have a strong leadership team in place. They use the FSP model to engage experienced clinical leads and CRAs, working under the direction of their own clinical director.
- A company is running trials in a new geographic area. They use the FSP model to take advantage of team members in varied locations leveraging the CRO’s specialized local infrastructure and pre-existing knowledge of local regulations and customs.
In each of these scenarios, the sponsors’ desire for direct involvement and decision making in their clinical trial makes the FSP model a clear fit. But what if your company is just starting out with an FSP model and doesn’t have the necessary in-house processes or systems in place? Does this mean the FSP model is not right for you? Not necessarily. Who better to write efficient processes and inform on system selection than functional experts who have seen it all?
For example: When FSP providers become part of the team
Within some companies—medical device companies in particular—individual divisions operate with autonomy, following their own preferences. That includes whether to fully outsource trials, or whether to be more hands-on. One of our clients has a division that values agility. Their culture leverages face-to-face interactions to work nimbly, allowing them to meet aggressive timelines. Consequently, all the biostatistical programmers from Premier sat on-site at the sponsor’s facility.
Throughout the course of a given day, the lines between CRO and sponsor became somewhat blurred, as the team jointly focused on the studies. In any study, there are critical points where important deadlines need to be met. During these times, our Premier team members frequently offered to stay late or work weekends. They, too, were invested in the success of these trials. Occasionally, Premier also flexed our resourcing upon request to support pivotal periods in the trial.
Premier Research prides ourselves on our ability to exceed the expectations of our large sponsors and remain nimble enough to meet any sponsor’s unique needs.
The value of choice
How is a sponsor to choose with this bevy of operating model choices—full service, FSP, consulting, or a mix? They don’t have to. It is even possible to switch models mid-trial. It simply requires a true full-service CRO, defined as a CRO with both the ability and the flexibility to customize an operational model to the sponsor’s unique desires and needs. The sponsor should be comfortable with the degree of involvement, the degree of control, and the expertise of their team, as they gather the data needed for regulatory success and product launch.
Premier Research offers precisely that flexibility. We are an industry-leading CRO with renowned FSP capabilities, end-to-end full-service offerings, consulting skills, and the ability to manage standalone projects. Critically, we have an established track record of creative approaches to operational models that enable us to provide precisely what a sponsor needs at every stage of a trial. Contact us to learn what that can mean for your study.