The Evolving Landscape: FSP vs. FSO

Recent industry analyses highlight a growing preference for FSP models over FSO. A 2024 survey revealed that 41% of biopharmaceutical companies have increased their use of FSP outsourcing, compared to 27% for FSO . This trend underscores the industry’s move towards models that offer enhanced adaptability and resource optimization.

The FSP model allows sponsors to outsource specific functions—such as clinical monitoring, data management, or biostatistics—while retaining strategic oversight. This targeted approach contrasts with the FSO model, where a single contract research organization (CRO) manages the entire clinical trial process.

The table below identifies key strategic differences between the two models.

Advantages of the FSP Model:

1. Enhanced Flexibility and Scalability
   FSP partnerships provide sponsors with the ability to scale resources up or down based on project needs, enabling more responsive and efficient trial management .
2. Access to Specialized Expertise
   By engaging FSPs, sponsors can tap into a pool of specialized professionals with deep expertise in specific functional areas, leading to improved trial quality and outcomes.
3. Cost Efficiency
   FSP models often result in significant cost savings. For instance, KPS Life’s FSP approach has demonstrated an average of 30% reduction in study costs through efficient resource allocation and management.
4. Improved Operational Control
   Sponsors maintain greater control over trial operations, as FSPs integrate into the sponsor’s existing infrastructure and processes, ensuring alignment with organizational standards and objectives.

KPS Life’s FSP Model: A Strategic Advantage

KPS Life’s FSP model is designed to align seamlessly with Sponsors’ operational framework, offering:

• Dedicated Teams: Professionals embedded within the sponsor’s infrastructure, ensuring consistency and continuity.
• Customized Solutions: Tailored approaches that meet specific project requirements and organizational goals. 
• Efficient Resource Management: Optimized allocation and redeployment of resources to maximize productivity and cost-effectiveness.
• Strategic Oversight: Maintaining sponsor control over critical trial aspects while benefiting from the FSP’s specialized capabilities.

KPS Life Differentiators

One of the notable differentiators of the KPS Life FSP model lies in the flexibility and customization we offer to become a unique resourcing solution to the Sponsor. It is a scalable model allowing the Sponsor to adequately resource your respective departments with direct involvement with candidate identification in line with increased or decreased support requirements in real time without the additional burden of HR processes (such as hiring and onboarding, associated with permanent headcount).

Our embedded resourcing model focuses on the economics of delivery while maintaining the standardization and consistency necessary to drive high-quality data output and efficiencies from engaging our broad spectrum of agile FSP solutions. Another demonstrated benefit of the KPS Life model is that it enables the assignment of best-in-class resources by function and delivers a fully dedicated team curated specifically for your stated functional needs. As we shared, KPS Life maintains a +90% retention rate of our team assuring continuity and consistency of delivery on a given project. This not only provides ‘peace of mind’ but affords the Sponsor greater span of control and the acceleration of development timelines at dramatically lower costs.

Governance: KPS Life Concierge Approach

At KPS Life we understand the importance of governing our relationship with the Sponsor for the duration of the program. We employ a high-touch philosophy that embraces the true meaning of delivering customer satisfaction by ensuring our organization, to include the executive sponsors assigned to this project are engaged and invested in the positive outcome of your projects.

The concierge methodology we have initiated at KPS Life aims to save time, effort, and energy for the Sponsor team. The Sponsor will have total access to our executive sponsors to insure rapid de- escalation of any issues that may arise or the immediate removal of any barriers to success on the protocols. KPS Life is committed to meet your needs and expectations of this project.

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KPS Life Welcomes Mark Ridge as Chief Executive Officer

We are pleased to announce that Mark Ridge will be joining KPS Life as our new Chief Executive Officer, effective October 1, 2024. Mark brings a distinguished track record of leadership in clinical trial operations and commercial operations, making him an ideal choice to lead KPS Life into its next phase of growth.

Mark succeeds David Kelly, the respected founder of KPS Life, who has led the company with remarkable vision and dedication over the past 16 years. Under David’s leadership, KPS Life has grown into a strong and high-performing company, known for its commitment to excellence and industry-leading FSP solutions. As David transitions out of the CEO role, he will continue to play a pivotal role in the company as President and Executive Chairman. We are grateful for David’s unwavering commitment and are excited to see KPS Life continue to thrive under Mark’s leadership.

Mark’s extensive experience spans over two decades in the pharmaceutical industry, where he has successfully overseen large-scale clinical trial operations and driven commercial success across global markets. His leadership has been instrumental in advancing clinical development programs and ensuring that critical drugs reached the market. Mark has led the successful approval of five key drugs, underscoring his deep expertise in navigating the complexities of the drug development process.

Beyond his clinical trial operations leadership, Mark has also demonstrated significant commercial acumen, managing global commercial functions that delivered substantial growth and value. His ability to integrate strategic insights into both R&D and commercial operations has consistently resulted in optimized outcomes, benefiting both the organizations he has led and the patients they serve.

As Mark steps into his new role at KPS Life, his experience in clinical operations and commercial strategy will be invaluable in enhancing our service offerings and strengthening our relationships with clients. His leadership will ensure that KPS Life continues to be a trusted partner in the clinical research industry, delivering the highest quality service and support.

Please join us in welcoming Mark Ridge as the new CEO of KPS Life. We look forward to the innovation and growth his leadership will bring to our organization and our clients.

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Sponsors and CROs employ CRAs to monitor clinical study sites. Because most site monitoring is done in the field, it is challenging for study managers to know and understand if CRAs/monitors are conducting their duties effectively and efficiently. Study managers have even less contact with home-based, regional CRAs.

Study managers can measure CRA performance by the volume of CRF pages reviewed, data query rates, visit reports, and feedback from site and project staff. However, these measures provide only ‘indirect data’ on how CRAs actually conduct study visits. Many study sponsors therefore employ co-monitoring/oversight visits to directly evaluate CRA performance and facilitate training.

The following process can help to achieve successful co-monitoring/oversight visits:

Identify the Oversight Monitor(s)

Oversight visits can be conducted by CRA managers, trainers or dedicated oversight monitors. Effective oversight monitors must be expert site monitors. They must also be intimately familiar with the protocol and other study documents. Without this knowledge, they will be unable to assess the CRA’s knowledge. Further, they will be oblivious to much of what happens during the site visit.

Prepare for the visit

The oversight monitor consults with the study manager about which sites are suitable for co- monitoring visits. He/she discusses any areas of special concern relating to the CRAs, sites and the study in general. He/she ensures that the study manager understands the process, expectations and objectives for the visit.

The oversight monitor informs the CRA of the upcoming oversight visit. They discuss suitable dates. They discuss any areas of special concern to the CRA. The oversight monitor ensures that the CRA understands the process, expectations and objectives for the visit.

Conduct the visit

The key to a successful oversight monitoring visit is a professional, structured, methodical and consistent approach. Although practices vary slightly across companies, the fundamentals remain the same. Preparation, organization and communication are crucial.

The oversight monitor accompanies the CRA on a site visit. Prior to or during the visit, the CRA explains to the oversight monitor any open issues and presents his/her plan to investigate, document, and resolve them. The oversight monitor observes, evaluates and documents typical site monitoring activities, such as reviewing CRFs, source documents, drug accountability records, and the regulatory binder.

He/she assesses the CRA’s interaction with site personnel in activities like training, issue resolution, and goal setting. These documentation and interpersonal skills are the essential requirements for successful site monitoring visits. An effective oversight monitor also serves as the CRA’s mentor, providing guidance and validation through the entire process.

During the course of the visit, the oversight monitor asks the CRA a variety of questions, preferably relevant to the task at hand. The CRA’s answers demonstrate his/her level of knowledge about the protocol and other aspects of the study. The CRA’s responses to the oversight monitor indicate how he/she responds to questions from site personnel.

The oversight monitor should be as unobtrusive as possible and let the CRA lead the visit.

Follow-up after the visit

The oversight monitor writes a report on his/her findings. What are the CRA’s strengths and areas for improvement? This report not only identifies what went right or wrong during the visit; it also evaluates causation: Are problems due to the CRA’s lack of training or experience? Are they due to environmental factors such as fatigue or stress? Are personalities playing a role? Is there a problem with the protocol or CRF?

At the conclusion of the visit, the oversight monitor elicits the CRA’s perspectives. (It may also be useful to obtain input from site personnel.) They discuss the visit’s successes and problems. This discussion is conducted in a professional, supportive, courteous and non-judgmental manner to promote learning. The co-monitor welcomes the CRA’s questions, concerns and explanations. The CRA is more likely to accept the oversight monitor’s recommendations if the approach is mentoring rather than blaming. The oversight monitor communicates to the CRA that they are working together to accomplish the same goals. To identify a mistake does not a lesson make; to truly teach requires the insight to identify an issue, the emotional intelligence to deliver constructive criticism in a positive manner, and the patience and creativity to create and conduct a training plan that inspires the CRA to achieve his/her best performance.

Oversight monitors are often responsible for managing the resolution of problems identified in the report. Their report should include a corrective action plan. The plan may include training, follow-up by the CRA, assignment of issues to other personnel, and another oversight monitoring visit. The oversight monitor then follows-up on the results. Some problems are easily addressed with a bit of training for the CRA. It may be necessary to adjust the CRA’s monitoring schedule or switch the CRA to a site that might make a better personality fit. Follow-up activities are opportunities to make the study more successful, not to chastise the CRA or generate more frustration. The oversight monitor may need to address site concerns without undercutting the CRA. Fortunately, site monitoring is good experience for handling difficult situations professionally and non-judgmentally.

An effective oversight monitoring program advances the knowledge and skills of CRAs. It identifies and remedies CRA, site and general study problems, while also building the morale of both CRAs and site personnel. It gives study managers visibility into the field, so they can make more informed decisions. Not only is the current study more successful, but the CRAs start their next study at a higher level.

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There is continuous evaluation and varying opinion regarding the strategic resourcing models employed within the biopharmaceutical sector today. Notwithstanding the recent hurdles of COVID-19, understanding the human resource capital companies currently employ and the talent they hope to attract, is the foundation for creating effective strategies in workforce planning, proactive analytics, and overall talent supply chain management. The most viable of these strategies has been the utilization of a Functional Service Provider (FSP) model to augment and/or supplement in-house staff to meet the variable resource needs of a clinical operations team. This popular model was born on the heels of the various strategic partnering arrangements that evolved over time in the space and became a common offering within the outsourcing community. As a result of the many mergers and acquisitions in the space, very few pure-play, focused FSP providers remain on the landscape as the majority have been absorbed into large, ‘full-service offering’ CRO operations. Well beyond the recent pandemic and the challenges it presented to the life science sector, and with the expansion and transformation of R&D portfolios into more specialized drug compounds, the life sciences short- and long-term strategy to engage quality talent must in the end, enable scientists and clinical research professionals to focus on speed to market, innovation and rapid decision making to address the changing needs of drug development. Outsourcing trends are shifting rapidly in the drug development sector as it has become apparent that functional outsourcing versus a full-service CRO model can deliver demonstrated cost savings in terms of operational efficiency and the overall reduction of program budgets. As biopharmaceutical companies have increased their outsourcing, they have been forced to maintain an internal overhead associated with the oversight of the work performed by a third party FSO. Often, Sponsors have been able to reduce the amount of overhead devoted to full-service contracting by leveraging the FSP model. In an FSP relationship where the emphasis is on managing providers by function, Sponsors can maintain strategic oversight and direction.

The talent supply chain must become more flexible and adaptive as a standard to remain competitive in the marketplace; a key differentiating feature of the original FSP model. Further, biopharmaceutical and medical device companies must be tuned-in to the needs of this talent pool and better understand their personal desire for growth opportunities, job satisfaction, competitive compensation, daily intellectual stimulus, the collaborative nature of the work environment, and the overall reputation and corporate culture of the firm. The FSP model affords biopharmaceutical companies the flexibility and speed to talent acquisition they will need to address this new-normal in a post-pandemic workplace.

• The inherent benefits of the FSP model include but are not limited to the following characteristics:
• Embedded resources dedicated to a given project.
• Flexible and scalable roles to address the ‘peaks and valleys’ of the trial requirements.
• Sponsor maintains the name and brand connectivity with the sites, patients, and investigators.
• Inherently higher retention rates of team members.
• High quality deliverables of seasoned, credentialed professionals.
• Enhanced and streamlined communication pathways.
• More cost-effective use of R&D budgets

In the last decade, the markets for life sciences products and services have increased exponentially, so having the right talent is essential. Business operations have expanded to serve these markets, and the size and availability of the workforce has been a critical factor in industry growth. But both the industry and the workforce are changing, and employers must be proactive in planning to meet staffing challenges head-on when they occur. The pharmaceutical and biotechnology industries have historically failed to invest sufficient resources in building internal teams and developing long-term succession plans for their workforces. Instead, established firms are increasingly partnering with specialized organizations to fill their talent gaps in the short term. Stand-alone FSP solutions companies such as KPS Life can offer valuable assistance in locating contractors with niche skills, as well as streamlining and accelerating the hiring process to fill critical positions quickly.

In the end, biopharmaceutical companies need to take a holistic approach to their talent supply chain and human capital strategy to identify the right talent, at the right time, in the right place as an investment in their scientific frontier of drug development and leverage their proliferating product portfolios over the next decade.

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The COVID-19 pandemic has impacted every industry in a variety of ways. For biopharmaceutical companies, this impact has been as comprehensive as it has been intense, affecting everything from the supply chains for active pharmaceutical ingredients (APIs), clinical packaging, labor shortages and monitoring resources, and everything in between. But perhaps most important is their respective ability to conduct and deliver their research and development programs directly or through their selected vendor partners. The well-documented labor shortage has been driven by an increase in market turnover and poor retention of key personnel. Part of this dynamic can be attributed to shifting expectations regarding in-person work, coupled with a redistribution of talent to other sectors and an inherent dip in the labor pool, creating a hurdle that many are struggling to overcome.

This downturn has proven particularly challenging for full-service contract research organizations (CROs), some of which may try to address the shortage by overextending their existing labor force, stretching the geographic reach of site visits, and assigning multiple protocols to team members. This tactic may create additional churn for these organizations, with some experiencing turnover rates of as much as 100 percent within a clinical project conducted for a sponsor. In turn, many CROs may be tempted to fill workforce gaps with inexperienced personnel tasked with a workload that far outstrips their expertise and bandwidth, further exacerbating the issue.

Personnel shortages and expertise gaps across the biopharmaceutical research and development paradigm have widespread implications for the time and expense associated with the drug discovery phase, already beset with competing challenges and an ever-evolving regulatory landscape. These factors have likewise compelled many sponsors to explore decentralized clinical trials (DCTs) as a solution to the rigors of conventional on-site trials and their commensurate workforce needs. But this approach is also not without its pitfalls: for many, DCTs require an aggressive technology transformation plan to include an overhaul of their systems, network size and workflows, which can be further complicated depending on the country or region of the world where the trial is being conducted.

All of these factors serve to create a challenging landscape for the global labor market in life sciences. Biopharmaceutical companies can employ several strategic approaches to mitigate risk in this regard, addressing the evolving demographics of the global workforce and ultimately transforming their own paradigms to ensure their programs succeed. Functional service providers (FSPs) can offer sponsors a more cost-effective alternative providing a complementary and/or supplemental partner to their existing outsourcing strategy. This can afford them access to tailored expertise, experienced clinical monitors, FSO oversight monitoring and global project management without any appreciable change in their existing workflows.

Responding To Workforce Gaps With Flexible Support

More clinical trials were launched in Q4 of 2021 than ever before with 1,015 initiations alone. This surge, driven by pent-up new projects, combined with the 23 percent of launched projects delayed by the pandemic, has created a huge demand for qualified employees to execute these trials. The widespread workforce gaps that have opened across Europe, Asia, and other regions have complicated the current state of the drug development industry.

To increase revenue, CROs may look to maximize some of their key clinical monitoring metrics – “the units” (most pharma contracts with contract research organizations are unit-based, with one on-site monitoring visit equating to one unit). This can most often be accomplished by assigning junior staff and very often to multiple projects as noted earlier.

DCTs have been implemented, in part, to alleviate this pressure, but often, the challenges created by this emerging methodology will require additional site support for which sponsors may not have budgeted. In addition, within the last decade, the span of control has been increasing, which leads to insufficient or suboptimal support resulting in demotivation, undue stress and disrupting the work/life balance we all seek.

These factors contribute to significant staff turnover for trials, which directly impacts the quality of drug development and can ultimately jeopardize outputs and the success of the study. The dearth of quality data that can result from mismanagement of on-site monitoring is one of the biggest threats to the success of a trial; mitigating this risk comes down to ensuring knowledgeable, consistent on-site oversight and reporting. This can prove particularly difficult in the current environment, where many junior site monitors have been promoted quickly to encourage retention, resulting in personnel without the experience and knowledge base to best support complex studies. The CRA-investigator relationships that were been forged during the life cycle of a clinical study and were fundamental to the successful delivery of a study at site level are now disappearing due to turnover and virtual/remote monitoring strategies.

Despite the rapid changes that have occurred across the industry because of the global pandemic, the ability and willingness of companies to change their perspective to respond is lacking. The rate at which DCTs were adopted across the market escalated precipitously in the wake of COVID-19, particularly in North America. This uptick in utilization has come with challenges for even the largest, most established biopharmaceutical companies, and those challenges have been further compounded for companies operating outside the U.S., where problems such as language barriers, institutional reluctance, or resource constraints can slow or stall the adoption of innovative technologies and processes.

Lastly, while DCTs have their place in the clinical trial space, it will be years before their full potential is realized for a broad range of studies. Currently, the majority of DCTs are employed in straightforward trials, where patient outcomes and data are easily captured. Multi-site, complex protocols occurring in multiple languages in disparate regions are still largely conducted traditionally. This reality serves to strain a global biopharmaceutical workforce, requiring near-term solutions that can help progress the unprecedented number of trials in the current research pipeline.

Evaluating An Outsourcing Model For Improved Outcomes

There are several advantages to employing a FSP model to support a clinical trial. FSPs are contracted to perform functions for a biopharma organization that typically retains control over the systems, processes, and data at the core of a clinical trial. The potential benefits of employing FSPs are far-reaching: increased quality, decreased costs, strategic control, and greater brand recognition can all be achieved with the right structure. This proven methodology can help sponsors simplify oversight and reduce their administrative burden by assuming responsibility for performance management, staff oversight, and administrative activities. Because the model is highly scalable, it affords sponsors the ability to increase or decrease the level of support for their trials in real time. This approach can also result in significant cost savings – many sponsors report cost savings more than 30+ percent due to improved resource forecasting, allocation, and redeployment.

Because FSPs typically operate on less aggressive margins than some CROs, these providers are often able to hire more tenured clinical research associates (CRAs). This approach, coupled with a focus on retention, creates a pool of curated and dedicated labor wherein many FSPs can maintain teams with decades more experience than a full-service organization. The added flexibility can make them an invaluable complementary resource for companies with established insourcing and outsourcing models beset with inefficiencies. Even large biopharmaceutical companies, which may have their own internal clinical trial team, as well as companies with long-standing CRO partnerships, can stand to benefit from the supplemental, tailored oversight and human capital FSPs offer.

More than half of clinical trials are outsourced. Historically, the sector has seen increasing reliance on full-service CROs. More recently, however, this paradigm has shifted to reflect recognition of the benefits of FSPs in supporting these studies. FSPs are defined by their flexibility, which extends to the various costing models available to sponsors. These include:

• Full-time equivalent (FTE)-based models, which are built around agreed rates codified in the contract for FTEs, invoiced regularly
• Time & materials models, for which rates are based in hours booked and invoiced regularly
• Unitized models, which are contracted based on the number of units required to finish project tasks
• Bridging models, wherein a sponsor contracts an FSP’s resources as dedicated FTEs that will eventually be transitioned into sponsor employees
• Lift & shift models, which contract out the management and execution of a study to an FSP but allow a sponsor to maintain strategic control
• Rebadge models, wherein individuals or teams transition into FSP FTEs while maintaining their existing roles with a sponsor.

Summary

Ultimately, engaging an FSP model can allow sponsors to retain strategic control and achieve greater flexibility as a result. Creating an outsourcing model wherein multiple handoffs occur between disparate systems and processes can directly and negatively impact the quality of the work performed. Addressing these challenges for a global market plagued by workforce retention issues will require creative solutions that are workable in the short-term and scalable in the long-term.

The post Quality Data – How Resourcing Challenges Can Affect Clinical Trial Outcomes appeared first on KPS Life.

Outsourcing has become increasingly popular in the biopharmaceutical space, driven by enhanced cost savings, improved timetables, and streamlined risk management. While the rates at which biopharma’s outsourcing has accelerated over the years, there has also been a pronounced shift in the models they choose to optimize results.

The definition of full-service outsourcing (FSO) in the biopharmaceutical space can vary – many sponsors may consider their approach an FSO model despite having only outsourced their monitoring and project management, while others take an entirely hands-off approach. Similarly, those who utilize functional service providers (FSP) can range widely in how many functions they elect to outsource. Some may elect to outsource only one function, while others may contract out every function within a clinical development organization, depending on the sponsor’s individual needs. While each approach can be tailored to varying degrees to match the objectives of a given sponsor, FSPs differ from FSOs chiefly in that they utilize the sponsor’s systems and SOPs rather than those of a contract research organization (CRO). Furthermore, involvement in key trial design and insight into operational oversight forces the sponsor staff to be realistic on deadlines and cost overruns.

The FSP model has experienced an accelerated adoption and increase in popularity in recent years, due, in part, to the flexibility and control it affords sponsors when compared to FSOs. The potential benefits of employing FSPs are alluring – increased quality, decreased costs, strategic control, and greater brand recognition can all be achieved with the right FSP structure. Despite this, many clinical trial sponsors are reluctant to shift away from a more comprehensive reliance on the FSO model, having already transitioned many of their core functions to their CRO partners.

By fomenting strategic FSP relationships with outsourcing partners, a biopharma has the opportunity to build out and enhance their own core competencies while affording themselves access to specialized expertise, achieving cost-saving benefits in the process.

Shifting Models in an Evolving Industry

In 2019, the Avoca Group, a life sciences consulting firm focused on clinical trial execution, analyzed data from approximately 300 survey responses, representing more than 120 global individual sponsor organizations and over 150 contracting organizations, to determine trends in clinical outsourcing spending. Avoca found that among smaller sponsors (sales <$2 billion), more of their outsourced clinical development spend had been allocated to full-service providers when compared with their larger counterparts (from the top 50 biopharmas, sales >$2 billion), which maintain a relatively balanced allocation between full service and FSPs. This difference is anticipated to narrow to a more balanced allocation with smaller sponsors in the next few years, regardless of company size, according to Avoca.

The majority of the providers surveyed by Avoca indicated that a larger proportion of their revenue comes from FSPs than from full-service arrangements and that, like the sponsors surveyed, they experienced stability through 2021 in these relative allocations by model (2021: FSP, 53%; full-service, 47%). Using model-specific spend data to define its cohorts, Avoca compared models across four key clinical outsourcing health indicators – relationships, overall work, quality, and value – to examine the influence of model selection on these factors. In doing so, they found that FSPs were given slightly more favorable responses when compared to full-service in the areas of overall work, quality, and value.

While more long-term studies are required to determine the key drivers that influence these perceptions, the differences in sponsor experience between FSPs and FSOs represent an interesting opportunity within an industry driven by quality, time-to-market, and cost considerations. “We’ve been chronicling the evolution of clinical outsourcing for many years – since the late ‘90s – and a lot of what we’ve examined over time are the relationship variables at play,” said Patty Leuchten, Founder of WCG Avoca and Chief Change Officer of WCG. “We’ve been looking at these things longitudinally, and interestingly, we’ve found that companies employing FSPs or with experience utilizing FSPs reported higher levels of satisfaction around overall quality. Within that, we were able to identify two major drivers: flexibility and control.”

Despite their increasing use, some misconceptions exist surrounding FSPs, particularly when compared to FSOs, which have held a larger share of the market in the last few decades. More recently, an increasing number of sponsors, particularly larger and more established ones, have embraced a hybrid approach to outsourcing, employing both FSPs and an FSO model, which maybe makes sense as a transitional state while moving to an internal/FSP model or as a way to integrate smaller acquisitions which typically use the FSO. One might question the hybrid choice if this is a long-term option as it results in increased overhead to manage different models and can be confusing for internal staff who have to operate across both models.

Establishing an Outsourcing Strategy

For any biopharmaceutical company evaluating their outsourcing strategy, their foremost consideration should be what they consider to be their desired strengths. What are their core competencies? What do they want to maintain control over, and what can they more readily outsource – e.g., for a large biopharma company, study design, analysis, and interpretation of study data might be considered core competencies, whereas monitoring, data management, and programming might be considered non-core. However, designating an activity as non-core does not suggest that it is unimportant or that the biopharma company does not require sufficient expertise to oversee this activity.

Building a strategic sourcing strategy requires investing in certain core competencies while divesting in other areas, which can often equate to a multi-year process. But failing to engage in this strategic planning can also have wide-ranging implications for biopharmas that, in a few years’ time, may result in widening gaps between those who are proactive in evaluating their outsourcing models and those who delay. “After deciding on core/no-core competencies, companies should consider how they will achieve standardization across studies and programs, flexibility/ease in changing providers and optimize oversight and quality”, said Adrian Otte, a board member for KPS Life. “Within these two main models, I think there is a fundamental difference in how you’re able to standardize. It isn’t something you have to worry about as much with a single study, but once you’re managing multiple studies across multiple programs, it becomes integral.”

Standardization can become more difficult in an FSO model, particularly one that incorporates multiple CROs with disparate systems, standards, and processes. Partnering with a single, large CRO and using their systems and processes may minimize a sponsor’s issues surrounding standardization, but this sort of arrangement can create concerns for sponsors wary of entrusting the entirety of their portfolio to one partner and diluting a risk mitigation approach to their drug development portfolio.

Such sole provider relationships, especially in the FSO model, can lead to lack of competition and flexibility in the event that a company may need to change partners. For those locked into the FSO systems and processes, it can be very hard to transition a study until that study is completed. In contrast, FSP partners typically work on the study within the biopharma companies’ systems and processes so a new partner can be brought on, trained, and the study transitioned at almost any stage. Sponsor quality oversight is also easier when programs are conducted in the pharma company systems and processes rather than trying to achieve adequate oversight through multiple FSO supplier systems.

Achieving Flexibility for the Future

Establishing an outsourcing model and maintaining it can be very important for a biopharmaceutical company: Avoca’s study also found a strong correlation between the longevity of an FSP partnership and the satisfaction emanating from it. While arriving at this equilibrium is possible in the FSO model, the potential for turnover is also greater with an FSO – sponsors tend to transition to new CROs every few years, dissatisfied with some aspect of their performance. “In my experience, it is the FSO bidding process that often creates unrealistic expectations about recruitment rates, with CROs erring toward aggressive recruitment numbers to wow the biopharma management team, which often lacks the expertise, data access, or time to critically review these projections,” Otte said. In contrast, most FSP models require the biopharma company to “own” the study design, site selection, and patient recruitment projections; as such, those tend to be more carefully researched and realistic. Owning aspects such as site selection and patient recruitment does not have to mean that the biopharma group has all the necessary staff or systems in place to complete these activities, but they need to have strong capabilities in order to select specialty providers on a case-by-case basis.

The unique challenges biopharmaceutical trial sponsors face may be driving their shifting outsourcing paradigms, contributing to the space’s overarching trend toward FSPs. Part of this shift can be seen among the largest biopharmas: nearly half of the top 10 companies in the space are moving toward a mixed model (especially for CRAs) that incorporates both FSP and internal resources to further bolster their leadership in certain therapeutic spaces. For many of these companies, the need for continuity of sourcing partners and for internal expertise surrounding their products and pipeline have superseded the comparative convenience of full-service outsourcing. “In thinking back to conversations I’ve had with executives from pharma organizations that had no experience with the FSP model, a common assumption was that there is less of a focus on relationship building compared to FSO models. That simply isn’t the case,” Leuchten said. “In my experience, the focus on establishing enduring relationships with FSPs can be even stronger compared to FSOs because of the typical longevity of these relationships and the need for nuanced conversations around client expectations.”

But even small, niche, and nascent biopharma companies can gain from evaluating their outsourcing strategy early and often. Many emerging companies, viewing their approach in the short term, will choose an FSO model for its seeming simplicity. As the company grows and morphs, its needs change, and it may transition from CRO to CRO until it has formed a large network of providers that has resulted in a patchwork of processes, making standardization next to impossible and quality oversight very difficult.

Ultimately, determining the outsourcing model that is the best fit and right-sized for a biopharma conducting clinical trials is a critical decision. By engaging an FSP, particularly for monitoring and project management, sponsors can achieve better standardization, leading to better quality oversight and lower costs.

As biopharmas continue to specialize in certain pipelines and therapeutics, the need for partnerships that are both long-standing and adaptable has made the FSP model increasingly popular. And with longer-term established FSP/pharma relationships comes the opportunity to better engage with clinical sites through experienced staff who know the product and are familiar with trial processes and issue escalation.

The post The Evolving Trial Sourcing Strategies Of Full-Service Versus Functional Methodologies appeared first on KPS Life.

“We are excited to announce the opening of our European Headquarters in Warsaw, Poland,” said David Kelly, President & CEO of KPS Life. “This is a natural step in our global expansion strategy which positions KPS Life to serve our existing and growing base of clients who require high quality talent as they execute against their drug development initiatives. The KPS Life Functional Service Provider (FSP) model is a proven alternative to traditional staffing and full-service outsourcing methodologies and affords our sponsor partners the opportunity to contract dedicated, embedded resources to complement their clinical operations’ teams”

With an extensive network of existing resources deployed in 45 countries, the office in Poland provides a centralized pathway to quality medical research facilities and access to talented and experienced clinical research professionals in multiple therapeutic areas for clinical drug development.

“The opening of the Warsaw office signals our commitment to enhance and further grow our global presence and establish a facility in a central European location to serve our clients’ needs going forward” said Dr. Armand Czaplinski, General Manager, European Operations. “The office will be staffed with a highly experienced recruitment team, clinical operations personnel, and Business Development professionals. We are committed to continue to expand our global presence and capabilities in the months to come.”

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AcceleTrial provides access to a built-in global database of over 200,000 objectively ranked investigators and sites as well as an intuitive automated workflow to ensure study start-up progresses effectively. In addition, LINEA’s patient recruitment offering ensure that teams launch their trials with recruitment realized.

The KPS Life Functional Service Provider (FSP) model ensures the assignment of best-in-class talent resources by function. The model curates experienced talent and provides consistent delivery to ensure high-quality clinical trial management and on-time delivery.

“KPS Life’s embedded resourcing solutions provide greater control of the trial development and execution,” said Kevin Duffy, Chief Commercial Officer, of KPS Life. “This partnership will give access to diverse clinical research sites, embedded human capital resources and speed to recruitment which facilitates sponsors to quickly and accurately execute their trials.”

“Clinical teams are required to operate in ever changing environment demanding faster and different approaches to identify the right sites that can contribute diverse patient populations and complete the trials in an expeditiously” said Kathleen Colatrella, Founder and President of LINEA. “We are excited to begin this partnership and know that together we will make a difference in the industry on how clinical trials are launched, recruited and executed.”

Combining of LINEA and KPS Life capabilities will result in outcomes that will definitely impact the sponsor’s programs. When a trial is optimized and proceeds efficiently, a greater number of patients can benefit from these efforts.

About LINEA System, LLC

LINEA System is a leader in helping accelerate clinical trials by leveraging data and automated technology in a completely new way. The company specializes in clinical site and investigator identification, feasibility, and site activation. LINEA System’s cloud-based Study Start-Up System (SSUS), AcceleTrial, enables sponsors to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and patient recruitment. For more information, visit https://www.lineasystem.com.

About KPS Life

KPS Life (www.kpslife.com) is a stand-alone functional service provider (FSP) that offers global functional clinical trial outsourcing services to pharmaceutical and biotech companies of all sizes across all phases of clinical trials. Services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics and medical writing.

KPS Life Press contact: [email protected]
Linea Press contact: [email protected]

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“Quality is the hallmark of our FSP solutions. We believe it is vitally important to ensure that our CRAs maintain a high level of core monitoring competencies,” said George Sawicki, COO at KPS life. “After a rigorous evaluation of training platforms, our Global Clinical Operations leadership clearly identified craSIM as the best choice for our upskilling strategy to ensure quality monitoring.”

“CRA Assessments is thrilled to partner with KPS Life in executing their ongoing strategy to elevate their CRAs to the top performers in the industry,” said Gerald DeWolfe, Founder & CEO of CRA Assessments. “KPS Life truly shares our passion for improving the quality of clinical monitoring in a manner that is cost-effective, easily accessible, consistent and objective.”

ABOUT KPS LIFE
Operating in 48 countries across the globe, KPS Life is a stand-alone, global functional service provider (“FSP”) that offers a clinical outsourcing solution to the Biopharmaceutical and Medical Device & Diagnostic sectors across all phases of clinical drug development. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. The KPS Life FSP model is a proven alternative to traditional staffing and full-service organization methodologies and affords sponsors the opportunity to contract dedicated, embedded resources to complement their clinical teams while maintaining brand identity and strategic control of assets.

ABOUT CRA ASSESSMENTS
CRA Assessments (https://craassessments.com) provides the only objective and comprehensive monitoring simulation that evaluates the knowledge, skills, and abilities of Clinical Research Associates (CRAs) in the clinical research industry. The craSIM technology platform allows CRAA to provide a simulation that can identify deficiencies and provide targeted feedback and training to develop CRAs. The process also incorporates a post-training simulation to allow for direct measurement of improvement. CRAA has evaluated over 6,700 CRAs in 70 countries to date.

KPS Life Press contact: [email protected]
CRAA Press contact: [email protected]

The post KPS Life Partners with CRA Assessments to Ensure High Quality Clinical Monitoring appeared first on KPS Life.