Study Design

Global FSP: The Expertise You Need. Exactly Where You Need It.

In the normal course of a clinical trial, delays are often accepted as part of the process. For instance, data entered by the site may not auto-encode correctly and therefore require further review by a medical coder, generally within five days. But in the fight against COVID-19, time is especially critical. A large pharmaceutical company utilizing Premier Research’s Functional Service Provider (FSP) model asked if we could accelerate coding turn-around time to just six hours so that every piece of information could keep moving without delay. Thanks to Premier’s access to global resources, we were able to say yes.

Under an FSP model, you gain access to a dedicated corps of experts that works alongside your study teams to deliver long-term support for key functions and meet project-specific needs. This allows you to leverage existing infrastructure and expertise in a way that is both flexible and scalable, with none of the constraints and capital investment triggered by hiring full-time staff. But the location of those existing resources can have a big impact on your trial, particularly when the resources are only based within a small region.

Global FSP resources offer three critical advantages:

Embedded local knowledge: When working across time zones and cultural barriers, particularly in emerging markets such as India, China, and South Korea, on-the-ground expertise is essential — both for companies based in these countries as well as those in the US and EU looking to do business in the APAC region. With knowledge of the local language, culture, and, critically, regulations, Premier’s functional resources in these countries are able to advise on everything from tax code impacts on site payments to targeted patient recruitment strategies — knowledge that can enable you to globalize a study regardless of where you’re headquartered while minimizing delays and disruption.

Streamlined collaboration with your team: Global FSP teams operate where you operate. So if your team members in Europe need overflow support, they receive that support from people working in Europe. If you are working with a team of CROs in multiple locations, the FSP team can match those locations one for one, always working in the same time zone to partner most effectively.

Nonstop Availability: Often, companies only need targeted help—data cleaning during a normal eight-hour block, for instance. But sometimes, additional support is required. In these cases, a global team can cover a few extra hours on either side of the normal day, expanding the “day” to 12 hours or even—as in the case of our COVID-therapy-developing partner referenced above—around the clock.

In short, global FSP services can be used in a range of situations to leave the control in the client’s hands while delivering total flexibility in location, timeline, stage, and department.

And the COVID trial? Premier harnessed our global teams to provide 24/7 service across six functions, speeding data to reviewers and statisticians, accelerating analysis, and driving towards conclusions. The customer was so pleased with the results that they have now adopted the model to fast-track other high-priority studies.

From targeted local knowledge to 24-hour support, Premier’s global FSP resources can be tailored to your study’s needs. Ask how Premier’s network of experts — always backed by Premier data systems — can move your study forward.