Efficient Outsourcing: How Global Resourcing Drives FSP Success

Discover how resource availability and flexibility across time zones drive smoother, more efficient outsourcing operations.

In an increasingly competitive clinical trial and post-marketing surveillance sphere, many companies have turned to outsourcing models to rapidly expand their capabilities, more efficiently leverage internal resources and reach a broader population of trial participants and research personnel. As more sponsors rely on outsourcing, the functional service provider (FSP) partnership model is growing in popularity, as confirmed by a recent survey of biotech and biopharma leaders showing that FSP use has increased in the last two years for 41% of respondents, while only 29% of respondents reported increased use of full-service outsourcing (FSO) engagements.

In this blog, we’ll explore the benefits associated with employing global resources across time zones for FSP engagements and how PPD^® FSP solutions utilize different regions to drive more efficient clinical development operations.

Global Outsourcing Increases Efficiency of FSP Engagements

The FSP model, in which all or most of a single function (such as data management, biometrics, clinical monitoring, medical writing, regulatory affairs or regulatory publishing) is outsourced to an external partner, is a popular choice among sponsors looking for resource flexibility. By outsourcing individual functions, drug developers retain control and complement their existing strengths with an outsourcing partner’s deep bench of resources and clinical development expertise.

As a result of this flexibility, FSP engagements provide an ideal path for companies to outsource clinical development functions in locations throughout Asia-Pacific, Latin America, and parts of Europe, Africa and the Middle East. FSP engagements enable sponsors to scale projects beyond their own capabilities or facilitate entry into global markets. Companies that are based exclusively within North America and/or Europe, for example, can only access a fraction of the potential staff that would be made available by outsourcing. This, in turn, may extend timelines and make resourcing less efficient. Moreover, by outsourcing individual functions to FSP providers, sponsors expand their capabilities while minimizing the costs and time associated with hiring in-house personnel. They can then better focus their resources on optimizing more specialized internal capabilities.

While there can be significant benefits, some companies are hesitant to pursue work globally due to concerns over quality, talent acquisition and retention, time zone coordination and more. An FSP partner that has established operations in global locations provides sponsors with the confidence they need to fully leverage a more flexible infrastructure and greater support. PPD FSP solutions tap into this robust, global infrastructure, providing the breadth and depth of functional expertise sponsors need to more efficiently meet their timelines.

Robust Operating Processes Promote Excellence in Global Outsourcing

For companies based in North America and Europe, outsourcing work to different regions may be perceived as challenging, but strong recruiting and training infrastructure can circumvent potential issues. For example, a company seeking medical writing support in English may have concerns about sourcing candidates in regions where English is not a primary language. Non-native speakers may be capable of writing most clinical trial documents, but sponsors may hesitate to outsource globally if they aren’t confident that consistent, high-quality deliverables will be available for all their project needs.

PPD FSP solutions circumvent this by thoroughly vetting personnel for written and spoken language competencies and function-specific capabilities, regardless of location. In biostatistics and programming, for example, this guarantees that global support personnel are true experts who can adapt to the specialized needs of a client’s project and work within their systems and platforms. Quality and consistency are a priority for every function supported by PPD FSP solutions personnel, from data management to clinical monitoring. Across our functions, PPD FSP solutions also provide personnel with the same onboarding and training regardless of their location, ensuring every team is comprised of highly qualified individuals.

Leveraging Time Zone Differences to Benefit Clinical Development Operations

Navigating communication and project continuity over wide time zone differences has historically been regarded as a potential drawback or obstacle in global outsourcing. Regardless of the region that’s managing an outsourced function, sponsors need a reliable and responsive point of contact within the team, effectively accessible via “speed dial” at all times.

That mindset is changing. Partnership with a dedicated, experienced FSP provider that has well-established operations throughout the world ensures that a point of contact is always available, even outside of their local working hours. Importantly, PPD FSP solutions see that time differences aren’t an obstacle — they create new efficiencies for sponsors outsourcing a service.

For example, if a sponsor based on the East Coast of the United States reviews a document and submits comments by the end of their business day, a medical writer based in the Asia-Pacific region can deliver edits by the following morning. With a secure and reliable line of communication and well-coordinated teams, outsourcing globally in FSP models enables company operations to “follow the sun” and proceed more efficiently than they would in-house. We have this established global outsourcing presence and fully leverage it to implement a follow-the-sun model with extensive staffing resources and dedicated team structures that ensure reliable, high-touch communication.

A Proven FSP Provider is Critical for Sponsors to Gain Advantages in Outsourcing

Not every FSP provider is created equal, so selecting a partner with established operations across regions and robust recruitment, training and onboarding processes is essential for sponsors to overcome common concerns about outsourcing across locations and time zones. In doing so, they access the efficiencies of global outsourcing while receiving high-quality, end-to-end services in their chosen functions. PPD FSP solutions, for example, draw from a pool of more than 30,000 professionals worldwide, all of whom are backed by the full force of the PPD global infrastructure, training, resources and expertise to ensure preparedness for any project.

High turnover rates can be another source of hesitation for companies looking to outsource functions to different regions. Without strong retention rates, projects are staffed with short-term, less experienced personnel who are less likely to see a project through from start to finish. This can compromise the quality of services and ultimately threaten the benefits of outsourcing to other global regions.

Partnering with a CRO with low turnover rates enables pharmaceutical organizations to work with staff for extended periods. Team members build relationships and become engrossed in the sponsors’ standard operating procedures (SOPs), culture and more. We have a strong track record of staff retention among personnel in cost-efficient locations. Compared to the industry average turnover rate of 20% or greater, our average is around 12% and trending downward. Our strong professional development programs are foundational to this success, providing dedicated, in-depth education through specialized programs such as our CRA Academy and cell and gene therapy-specific training and forums. By investing in strong onboarding and ongoing professional development and training opportunities, PPD FSP solutions attract and retain professionals worldwide to ensure FSP arrangements are consistently supported by experienced, high-performing personnel.

The following case study illustrates the capabilities of PPD FSP solutions in staffing across global regions.

Case Study: Staffing Medical Writers Across Regions Using an FSP Model

In January 2018, PPD FSP Medical Writing solutions engaged with a European pharmaceutical company to provide medical writing services using resources in the Asia-Pacific region.

• Need: The client required support for writing protocols, informed consent forms, clinical study reports and common technical document (CTD) modules. This partnership required PPD FSP Medical Writing solutions personnel to leverage the client’s technology infrastructure, SOPs and templates to essentially serve as an extension of the internal medical writing team and fit within the client’s culture and internal operating structure.

• Approach: PPD FSP Medical Writing solutions and the client approached this initiative with a shared vision, taking a joint management team approach to resourcing, portfolio planning and risk management.

  PPD FSP Medical Writing solutions developed a dedicated team located in Asia-Pacific to integrate into the client study teams, as well as Europe-based management to support communication across time zones.The partnership utilized resources in Asia-Pacific to build cost efficiencies into the model. PPD FSP Medical Writing solutions employed medical writing personnel based in India, China and the Philippines. Over time, the partnership established additional cost efficiencies where program management was also moved to Asia-Pacific.

• Results: The shared vision was realized through effective governance and an empowered, highly functioning team aligned to the client’s corporate goals and objectives. Key performance indicators (KPIs) and service-level agreements (SLAs) were linked to the client’s team survey, where PPD FSP Medical Writing solutions scored 5.5 out of 6 on measures of proactivity, timelines, quality, project management and communication. Asia-Pacific Medical Writing solutions team members had a turnover rate of just 8.3% — less than the global turnover rate of 12.8%.

This collaboration has resulted in a longstanding relationship uniquely suited to the needs of the client with a team based in Asia-Pacific. Engaged client contacts and a PPD FSP Medical Writing solutions team working across time zones provide effective program-level support in a dynamic clinical and regulatory landscape.

Unlock New Potential with FSP Engagements

Biotech and biopharma organizations are becoming increasingly reliant on outsourcing models to facilitate their clinical development projects. Expanding operations globally introduces new capabilities and efficiencies, but can present new complexities, including:

• Establishing a presence in these regions
• Finding qualified personnel
• Complying with region-specific hiring practices
• Successfully maintaining communication and operational excellence

By working closely with a proven FSP provider, clinical trial sponsors leverage the benefits and efficiencies of resources across global regions without sacrificing quality or convenience.

PPD FSP solutions boast a strong foundation of infrastructure and staffing resources around the globe to ensure every FSP engagement is served by the best talent, no matter where they are located. In turn, our partnerships provide the ultimate support for our clients to meet their timelines by rapidly ramping up engagements, maintaining high-touch communications and applying necessary staff and resources where and when they are needed. The result is a customized solution that achieves on-time, on-budget trial delivery and accelerates research success.