How to Extend FSP Models into Non-Footprint Countries

Navigating new markets with expert support

Functional service provider (FSP) models allow companies to outsource to fill small gaps in services or large-scale programs, such as a few clinical operations experts or a full pharmacovigilance solution. Of late, sponsors working with experienced third-party FSP providers are finding that one of the remarkable applications of FSP is its capacity to advance operations via non-footprint countries.

Non-footprint countries are regions where drug developers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drug developers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.

However, sponsors interested in unlocking the potential of non-footprint countries must do so with an experienced FSP partner. By doing so, companies can augment their ongoing clinical research and sidestep the challenges of global extension, such as language barriers and compliance concerns, without the need to manage the in-country presence themselves. This facilitates smooth, on-schedule operations, de-risking the pipeline.

How Can Custom FSP Models in Non-Footprint Countries Drive On-Time Delivery?

Clients benefit greatly from strategic partnerships with FSP providers that have the expertise, adaptability and precise operational requirements that deliver clinical development programs on time in non-footprint countries.

The Right On-the-Ground Expertise

One of the primary elements when tailoring an FSP solution for non-footprint countries is localization: having the right expertise in place to advance operations and avoid delays due to lack of the right resources. Non-footprint countries often have distinctive regulatory and logistical challenges that require specialized local expertise. A trusted FSP provider taps into its extensive network of professionals in these regions, seamlessly integrating them into client operations for a single key function or across the board for all phases of development.

• PPD FSP solutions, for example, have access to more than 30,000 clinical development experts in more than 160 countries who can mobilize quickly to keep projects on schedule. Additionally, the PPD FSP solutions team has more than 130 dedicated recruitment professionals to identify and recruit external candidates who bring relevant skills wherever they are needed, including in non-footprint markets. Our award-winning training programs provide all our FSP team members with a strong, standard foundation of knowledge that is continually updated to ensure preparedness for any project.

Adaptability with Your Workload

The flexibility of the FSP model allows drug developers to scale the resources, support and expertise to match shifting workloads in non-footprint markets. During critical phases of the trial, an FSP provider can rapidly allocate additional resources to ensure timelines are met, and during less intensive periods, the provider can scale down resources to control costs.

• PPD FSP solutions offer clients a choice of contracting options, ranging from partial full-time equivalents (FTEs) to fixed price and unitized models, to address the needs and challenges of varying organizations. This adaptability, combined with a deep well of talent and solid infrastructure for quick onboarding and deployment of team members, assures cost-efficient, bespoke FSP solutions.

An Extension of Your Team

Especially when moving into non-footprint countries, consistent oversight and high-touch communication are essential in transitioning functions from your company’s internal resources to an FSP provider. PPD FSP solutions establish dedicated leadership roles for coordinating critical functions in every FSP engagement – from setting a project up for success from day one with well-defined change management processes to providing comprehensive support throughout the study life cycle.

The ideal FSP provider should create for you a tailored FSP model that adapts the resources and expertise available in non-footprint countries to your study. Your partner should extend your existing standard operating procedures (SOPs) and systems to maintain consistency across operations and countries, eliminating the need for duplicate governance and to reconcile data across different platforms. They should also take responsibility for setting up direct lines of communication, clear management tiers and an organizational structure that aligns with your internal management. The result is greater efficiency and speed, even in countries in which you do not have dedicated staff or a homebase.

PPD FSP Solutions: The Right Partner to Extend Your Global Reach

With over two decades of experience and a wealth of expertise, PPD FSP solutions are a reliable partner to biotech and biopharma companies, helping them meet their timelines by delivering the best of the best: hard-to-find, top-tier staff who bring a customer-first, problem-solving mindset in non-footprint countries around the world.

Our experts deliver a breadth and depth of therapeutic and functional expertise unmatched in the industry, uniquely positioning us to deliver the right experience and knowledge to fill immediate resource gaps. We also offer dedicated roles focused on rapidly ramping up engagements, keeping you informed with high-touch communications and applying on-demand staff and services, as needed.

Whether you need to fill small gaps in services or outsource multiple functions across a portfolio, we deliver customized solutions tailored to your needs to provide much-needed resource flexibility, reliability and continuity for non-footprint countries.