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Case Studies: Three Ways Clients Have Found Success With the FSP Model

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As the drug development industry continues to evolve to meet a range of modern challenges, adoption of functional service provider (FSP) models is increasing. FSPs are related to full-service outsourcing (FSO) models, but present the opportunity for outsourcing by specific function while working within clients’ standard operating procedures (SOP) and systems. According to research by Avoca, the industry is showing signs of shifting more toward FSPs, which now make up more than 40% of the mix, a 46% increase over the past four years.

FSP outsourcing is proving a popular choice because it offers an effective response to three key industry challenges:

  1. The perennial need to optimize drug development timelines and get products to market faster.
  2. Unprecedented high demand for qualified talent, which has made staffing more challenging.
  3. The difficulty of maintaining positive relationships with the best sites to be regarded as a “sponsor of choice.”

Explore some recent cases where the PPD™ clinical research business of Thermo Fisher Scientific effectively used its functional service partnership model to overcome these challenges.

Speed to market

The pressure to bring a new drug to market is not particularly unfamiliar, but that doesn’t make it any less meaningful to today’s customers. To meet the speed-to-market demand, clients need to get sites and studies up and running as quickly as possible — a challenge that continues to be exacerbated by travel restrictions, whether pandemic- or economic-related.

Nearly 60% of respondents in a recent PPD™ Digital and Decentralized solutions survey reported that a patient’s ability to visit an investigative site was the most impacted aspect of their ongoing clinical trials during COVID-19. Accordingly, the focus on remote technologies and digital solutions has grown dramatically, with more than 50% of site survey respondents confirming that they have implemented remote monitoring visits, reduced site visits, and moved from paper to digital versions of patient clinical outcome assessments.

In the face of what the COVID-19 pandemic wrought on workforces everywhere, one client sought FSP support with contract and budget review for more than 20 global studies. This customer was hesitant to hire during the pandemic, making an FSP solution the best way for it to complete this necessary work without the burden of recruiting, hiring and onboarding new staff.

The most unique aspect of the project was that it would require one contract research organization (CRO), in this case, Thermo Fisher Scientific’s PPD clinical research business, to oversee collaboration across several other CROs — a rare occurrence in the industry that would present challenges of its own.

Our contract managers first worked with the clients to understand their must-haves, fallback language, escalation pathways and processes, as well as their preferred negotiation style and, in general, their expectations for third-party vendors. With all those details in place, we took on the role of customer — that is, collaborated with and supervised the work of CROs that are traditionally considered competitors.

The project required quick learning of other CRO processes and procedures to provide appropriate guidance and escalation pathways across the board. This included specific training for each sponsor, such as learning sponsor-specific SOPs for contract and budget negotiations — all while maintaining strict confidentiality for all parties.

With this much complexity and so many different stakeholders, clear communication was paramount. To that end, weekly briefings were delivered to study and CRO site contracting teams to track progress and set priorities. Weekly reports were also delivered to sponsors, including current country- and site-specific statuses, and incorporated discussions of any open issues.

The result was that the client’s critical activities were able to proceed without major disruptions, even in the face of a global pandemic. In fact, contract turnaround times met or exceeded industry benchmarks in more than 85% of sites.

Talent shortage

With demand for clinical research professionals at an all-time high, customers and CROs are competing for the same talent, resulting in a market-driven landscape and higher turnover. This leads to a lucrative environment for candidates, who are often faced with multiple concurrent job offers — but for CROs and their clients, it means increasing competition for resources.

For example, research from our FSP Industry Trends Report shows that within the clinical research associate (CRA) space in North America, the demand for professionals in that role is more than double the available capacity. This has led to an average increase in salaries of approximately 15% over the past six months.

In the face of similar staffing challenges, one European biotech with a promising pipeline and large investments turned to Thermo Fisher’s PPD clinical research business for help in quickly ramping up across many functions and therapeutic areas. Like many in the industry, this client had struggled to hire internally and to onboard and manage those they did hire, making full-time employee (FTE) based FSP resources an attractive option.

Among their specific needs was a dedicated FTE model for a broad range of services, including data management, medical writing, program leads, clinical supplies, regulatory, statistics and medical. They also needed the flexibility to leverage specialized experts and temporary solutions that would require time-and-material and hourly consulting capabilities. And all this staff would be spread across several countries throughout Europe and North America.

The ability to quickly meet all these challenges centered on three key roles: a dedicated FSP program lead, dedicated FSP recruiters and heavily involved FSP leads for each service area.

As trust was established, other senior and pivotal roles were added to drive the firm’s drug development strategy and maintain cohesive executive oversight. This included robust change management to help the client adjust to the FSP model and the streamlining of resourcing and onboarding processes to keep work moving quickly.

In very little time, we accounted for 45 FTEs (a figure that continues to grow), from the administrative level up to key development roles, such as managers, medical directors and program leads. Those 45 FTEs account for approximately 10% of the client’s headcount. As a result of this consolidation and streamlining, time-to-offer was reduced from more than 50 days to 36 — during the height of the pandemic, no less.

Becoming the “sponsor of choice”

With available resources at a premium and the increased focus on speed, it’s standard practice for investigative sites to prioritize clients and studies to ensure the success of their trials. As a result, clients are often vying for priority placement with those investigators and seeking ways to move to the top of sites’ “most-favored” lists.

So how do the select few make it to the top of the list? By clearly and effectively addressing the sites’ primary pain points, like CRA turnover, timely payment and prompt responses to protocol inquiries.

With so much riding on building and maintaining successful relationships, the CRA often becomes the face of the customer. Customers want to be able to prioritize sites, influence CRA behaviors and ensure an overall positive partnership with their key investigators. Considering these needs, FSP has become a popular option for sponsors who want to assign a monitoring team that can align to their specific systems and processes without carrying the long-term cost of hiring and managing the team.

A client operating under a decentralized model experienced this firsthand. In this case, the client had country affiliates that were able to determine their own staffing needs and select and contract with vendors of their choice. As a result, this client had to work across 130 different contracts spanning 46 countries.

Analyzing these operations, the company’s CEO found that this operating model increased the company’s overall burden (oversight, financial, administrative and legal), led to significant under-utilization, and lacked global transparency and uniformity. As a result, the CEO mandated that the organization reduce external spend on internally managed (insourced) trials by $15 million each year — without canceling or delaying a single trial.

The company turned to PPD clinical research services for a general solution that would apply across most therapeutic areas (hematology/oncology, neurology, respiratory, etc.) and offer a specialized solution for vaccines. A sole-provider model was proposed for global monitoring services related to their insourced trials, which would replace those 130 separate contracts with just one.

Under this proposal, more than 300 client staff, vendor staff and contingency workers were re-badged to to the PPD clinical research team. Seventy-five percent of these FSP offers were accepted, with an overall retention rate of 97% for the first six months.

With staffing issues resolved, more than 50 active trials were transferred, and 12 new studies were launched in the first year — all without a single delay. These new operations also reduced the client’s global clinical footprint from 46 to 20 countries, which decreased the financial, administrative and legal burden.

The changes created by implementing an FSP model drove significant savings, shaving $15 million from their budget in the first year. (Those savings are expected to grow to $21 million per year by the fifth year.)

These changes were delivered while maintaining very high levels of satisfaction: 97% of sites initially reported being “completely satisfied” with their transition to PPD CRAs; and by years three and four, 96% of sites continued to rate PPD CRAs “excellent or very good.”

Top-tier FSP experts tackle the industry’s biggest challenges

PPD™ Functional Service Partnership solutions help biotech and pharmaceutical companies solve their resource challenges by sourcing professionals from the same talent pool as our full-service engagements. That means PPD FSP solutions deliver the best of the best — hard-to-find, top-tier experts who serve as extensions of your teams — and deliver more experience, knowledge and expertise than other providers. In the face of significant industry challenges, we have the experience to deliver real, meaningful results that affect positive trial outcomes and significantly impact the bottom line. Learn more about PPD FSP solutions.