Despite the substantial innovation clinical trials have seen in recent decades, from study designs to endpoints, there have also been a number of regulatory changes from agencies like the United States (U.S.) Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The resulting increase in competitive pressures in the pharmaceutical industry has led to clinical trials becoming more complex over time, with longer study timelines but relatively static success rates. These changes to today’s landscape of drug development have necessitated a higher level of expertise and specialization that sponsors and contract research organizations (CROs) can resource best by forming strategic partnerships. These collaborations not only serve as the backbone that supports clinical research, but they are also crucial for improving operational efficiency and fostering innovation in the field.  

In this article, we will explore the role of strategic resourcing partnerships in clinical development, specifically highlighting the value of strategic resourcing solutions (SRS) and functional service provider (FSP) services. Readers will also gain insights into current workforce challenges in clinical research and how companies can foster strong, authentic strategic partnerships long-term. 

 

The Growing Shortage of Clinical Research Professionals (CRPs)

A recent study by Freel et al. (2023) revealed several findings that showed the field of clinical research in the U.S. is currently facing a considerable workforce shortage of clinical research professionals (CRPs). Their findings reported that for every experienced clinical research coordinator (CRC) seeking work, there are seven available job openings (1:7); this ratio is even greater at 1:10 for clinical research nurses, and for regulatory affairs professionals, it was a staggering 1:35.

As clinical trials continue to trend towards more complex study designs and longer timelines, the demand for CRCs within the U.S. job market is expected to grow an additional 9.9% between 2016 and 2026. In combination with a traditionally high turnover rate in CRPs, particularly those who are patient-facing, the ongoing workforce shortage has already been negatively impacting the conduct of clinical trials, with staffing issues having been reported in up to 95% of cancer centers. This CRP attrition crisis emphasizes the need for strategic partnerships, particularly with specialized organizations like TFS HealthScience CRO that have collected decades of experience with SRS and FSP services to address workforce issues like this. 

 

What are Strategic Resourcing Solutions (SRS) and Functional Service Providers (FSP)?

Companies like TFS are well-versed in leveraging SRS and FSP models to assist sponsors, investigators, and even other CROs with resourcing and building the right team of CRPs for their unique clinical trial needs. Strategic partnerships using SRS can benefit from solutions such as full-service outsourcing, professional insourcing of individual talent experts, recruitment services for a single resource or fully managed teams, and functional resourcing through the FSP model. Whereas the SRS model helps bring in the best CRP talent for clients across all clinical development functions and seniority levels, the FSP model enables efficient outsourcing of specific functional components of a clinical trial while allowing sponsors to retain control over the data and operations. Regardless, strategic partnerships that leverage either or both of these models offer significant advantages for sponsors looking to optimize their clinical development programs for greater efficiency and success.

To learn more about strategic resourcing solutions (SRS) from the TFS Intellect Hub, click here. 

 

Benefits of SRS- and FSP-Based Strategic Partnerships

Strategic partnerships in the pharmaceutical industry are not a new concept. The symbiotic relationship between sponsors and CROs has existed for decades, becoming especially critical during the COVID-19 pandemic. Strategic resourcing partnerships offer similar benefits, in that they ensure convenient resourcing of qualified experts despite widespread staffing challenges, as well as effective resource allocation and optimization. Sponsors can take advantage of strategic partnerships with SRS providers like TFS because these organizations already possess strong local networks to support CRP resourcing within several countries. In response to the growing demand for skilled researchers, SRS providers already have the resources, infrastructure, and specialized expertise to support cost-efficient, quick transitions from request to placement, as well as helping clients balance CRP assignments across multiple projects for more efficient resource utilization.

Outsourcing via FSP-based strategic partnerships also offers significant economic benefits, helping sponsors improve cost-effectiveness by enabling up to 30% more work to be done for the same cost. In addition to resourcing qualified CRPs through an SRS model, CROs serve as excellent outsourcing partners because they can be deployed to provide support in roles ranging from CRCs and nurses to regulatory affairs professionals. Ultimately, strategic resourcing partnerships that leverage these types of models help ensure that clinical trials are adequately staffed and less likely to experience timeline delays, therefore providing sponsors with considerable cost-savings.

In addition to addressing staffing challenges with targeted resourcing models, like those offered by TFS, strategic partnerships in clinical research also offer the following benefits:  

1. Addressing prohibitive costs of clinical trials by pooling resources, staff expertise, and sharing costs. 

2. Promoting scientific innovation and knowledge transfer by resourcing diverse and unique perspectives, expertise, and resources through strategic partnerships with various stakeholders. Examples of stakeholders include academic institutions, industry partners like pharmaceutical or biotech companies, and even patients.  

3. Optimizing patient recruitment and retention by leveraging existing patient networks, trial recruitment specialists, and social media campaign capabilities of CROs and research sites. 

4. Improving diversity and accessibility in clinical trials by fostering clinical research collaborations with experienced CROs that have a global presence and technological capabilities to support remote or decentralized trials.  

5. Strengthening a study’s reliability and generalizability by using strategic partnerships to integrate interdisciplinary or cross-sector expertise and insights.  

 

Maximizing Strategic Resourcing Partnerships Within Clinical Development

Strategic partnerships are crucial for ensuring the effective allocation of staff across projects and optimizing a clinical trial team to have the right skills and expertise at the right time. One of the key strategies for maximizing these partnerships is to clearly define the roles and responsibilities of each involved party. This involves setting up agreements and contracts that outline who is responsible for what tasks, when, and how to minimize potential conflict in advance and better streamline operations.

A strong strategic partnership is especially reliant on consistent and open communications between each stakeholder, specifically through regular meetings, frequent updates, and timely reports to keep all parties informed about progress and any potential issues. Such an approach is based on transparency and not only fosters trust but also facilitates proactive problem solving.

Lastly, to take full advantage of a strategic resourcing partnership, the unique strengths and capabilities of each stakeholder should be considered. Whether using one partner’s robust technological infrastructure for efficient data collection and management, using another’s expertise in patient recruitment, or resourcing qualified CRPs, capitalizing on each partner’s strengths can better optimize the clinical development process.  

 

Strategies to Maintain Authentic Strategic Partnerships Long-Term

Open communication and transparency are the cornerstones of facilitating trust within an authentic partnership. This means keeping all lines of communication open and being honest about capabilities, expectations, and potential challenges. All involved parties must also establish shared objectives from the start by identifying common goals and ensuring each side is committed to achieving them.

To maintain these strategic partnerships long-term, continuous effort is required from each stakeholder. For example, this could entail regularly reviewing and assessing the collaboration by evaluating performance against set goals, discussing any challenges or issues, and identifying areas for improvement. Another strategy is for each party to keep investing in the partnership, whether by providing resources for training and development, investing in technology to streamline operations, or even setting aside time for team-building activities.

Lastly, strategic partnerships within clinical development are most successful when each industry partner recognizes and appreciates the contributions of the other. This could be accomplished by acknowledging the unique skills and expertise that each party brings to the table, or even celebrating joint achievements. By showing appreciation, clinical research partners are more likely to share in mutual successes and feel a greater sense of teamwork, which can significantly strengthen a strategic resourcing partnership in the long run. 

 

Conclusion

In conclusion, strategic resourcing partnerships are becoming indispensable within the pharmaceutical industry to support modern clinical development. Partnerships with companies like TFS help address critical challenges facing today’s landscape of clinical research, particularly the CRP workforce shortage, by leveraging models like SRS and FSP. Strategic partnerships not only ensure clinical trials have the necessary staffing and expertise but also promote continuously optimizing operations to drive efficiency and innovation. Key strategies for maintaining such important collaborations include keeping open lines of communication, defining clear roles, and appreciating each partner’s unique contributions, among others. Although clinical trials are becoming increasingly complex and facing new challenges along the way, forming strategic resourcing partnerships is becoming a necessity to achieve success more cost-effectively.  

 

Why Choose TFS HealthScience as Your SRS Partner?

At TFS HealthScience, we offer a 100% dedicated team to support biotechnology and pharmaceutical companies throughout their entire clinical development journey. As a leading mid-sized CRO with a global presence across 40 countries, our customized approach, underscored by a deep commitment to understanding our clients’ needs, sets us apart. Our SRS and FSP services have been a trusted component throughout the entire clinical development journey since 1996 and our strategic resourcing experts possess a long-standing history of successful recruitment of CRPs for our clients.

Visit our website to learn more about the solutions TFS can offer for your next clinical trial, or connect with a TFS representative today!