Clinical research professionals (CRPs) play a critical role in designing, conducting, and overseeing clinical trials. One of the significant challenges faced in the clinical research industry is the sourcing and retention of experienced and qualified experts with skills that match the evolving needs of increasingly complex clinical trials. The clinical research industry is grappling with a need for more talent, especially those with the expertise to ensure that trials are conducted ethically, safely, and in compliance with regulatory requirements. To prevent disruptions in clinical research, research organizations leverage strategic resourcing solutions (SRSs) customized to fit their needs.

 

What are Strategic Resourcing Solutions (SRS)?

Strategic Resourcing Solutions (SRS) are tailored people-based solutions centered on an in-depth understanding of the challenges, needs, and goals of organizations conducting clinical research. Types of SRS include full-service outsourcing, professional insourcing of specific, individual talent experts, recruitment services for a single resource or entire managed teams, and functional resourcing through the functional service provider (FSP) model. The FSP model enables sponsors to outsource specific functional components of a clinical trial while still maintaining their control over the data and overall process. 

 

Importance of SRS in the Clinical Research Industry  

The clinical research industry has faced pervasive issues across the clinical research workforce. The shortage of CRPs has been growing for over a decade, with researchers predicting that the problems will likely intensify further. Workforce challenges are already impacting the ability to run trials. More significantly, the issues are increasingly nuanced as, e.g., the demand for a mix of skills and experience has changed with the increasing complexity of clinical trials and the shift towards decentralized clinical trials (DCTs). To prevent disruptions in clinical trials, research organizations leverage strategic resourcing solutions (SRSs) that fit their needs in a timeframe (short or long term) and scale (single talent vs. managed teams).  

 

Understanding the Role of Strategic Resourcing Solutions (SRS)

Clinical research involves the study of the safety and effectiveness of health interventions, which include new drugs, medical devices, diagnostics, techniques, and technologies. After being tested in a lab, new treatments move through clinical trials from Phase I to IV, where each phase has a different purpose, answers different research questions, and requires different CRP skills. Phase I trials study safety and identify side effects. In contrast, Phase II trials determine effectiveness and study safety further. Phase III trials confirm treatment effectiveness, monitor side effects, and compare the new treatment with standard or similar treatments.

Phase IV trials, which occur after a drug is approved by a regulatory authority like the U.S. Food and Drug Administration (FDA), allow researchers to track its safety in the general population. Contract research organizations (CROs) like TFS HealthScience (TFS) partner with sponsors to provide solutions from early phase planning and regulatory strategy to Phase I-III studies, post-authorization Phase IV studies, and Real-World Evidence (RWE). 

 

Challenges Faced by Clinical Research Organizations (CROs) and Sponsors  

The clinical research challenges faced by CROs and sponsors include participant recruitment and retention, ensuring trial diversity, site selection, regulatory barriers, and scarcity of talent and resources. The talent and resources challenge exacerbates all other challenges for several reasons. The CRP workforce shortage has been growing for over a decade, and it has the potential to hamper progress in clinical research. In the U.S., the shortage is most severe for site-based clinical research staff. According to Freel et al., there are seven jobs for every experienced clinical research coordinator (CRC) seeking work. For clinical research nurses, there are 10 for everyone seeking a job, and for regulatory affairs professionals, there are 35 jobs for every one job-seeker. The researchers anticipate that demand for CRPs will continue to increase.

The CRP shortage impacts the current overburdened workforce as the (2023) resignation rate for CRPs with a five- to 10-year tenure was 60% higher than in 2020. The resultant “war for talent” and unsustainable levels of turnover are exacerbated by CRP jobs having grown increasingly complex over the past 20 years.

Resource and staffing challenges are affecting the ability to run clinical trials, with additional concerns about the impact on research quality, compliance with Good Clinical Practice (GCP), and data integrity. Ultimately, the slowing of clinical research caused by resource and staffing issues impacts medical progress.

As indicated by Freel et al. (2023), the issues identified are likely to intensify further due to the rising number of clinical trials registered globally, the overall rise in trial complexity, and increasing expectations for the integration of innovative new tech in trials. The researchers also highlight the need for more diversity in CRPs. The diversity of CRPs has increasingly been recognized as essential for improving the diversity of clinical trial participants, which is necessary for the generalizability of trial findings to real-world populations2. 

 

How SRS addresses these challenges  

SRS are customized resourcing solutions based on an in-depth understanding of the challenges, needs, and goals of organizations conducting clinical research. For sponsors, SRS enables the management of clinical trials with greater efficiency, quality, and flexibility.  

 

The Key Components of Strategic Resourcing Solutions (SRS)

1. Recruitment and staffing services  

Depending on a customer’s requirement for clinical development function and seniority level, qualified professionals are identified for permanent hire.  

 

2. Project management support  

Project managers oversee day-to-day clinical trial activities and are the primary contact with sponsors to ensure clarity of communication. Project management support includes managing project activities, timelines, deliverables, and quality. In addition, project managers control the project budget, including pass-through costs.  

 

3. Training and development programs  

CRPs need the knowledge, skills, and abilities to ensure trials are conducted ethically, safely, and in compliance with regulatory requirements. Training and development programs include formalized and accredited academic degree programs, training to meet international competency standards, and competency maintenance through continuous professional development (CPD)1.  

 

4. Quality assurance and compliance oversight

For quality assurance and compliance oversight, resourcing solutions include providing experienced and well-trained experts to support and guide sponsors through local and global compliance challenges. These experts ensure that clinical trials are planned, conducted, and reported in compliance with relevant global regulatory requirements, guidance, and organizational standard operating procedures (SOPs). 

 

Advantages of Utilizing Strategic Resourcing Solutions (SRS)  

1. Flexibility and scalability  

Professional insourcing solutions are as scalable as sponsors require, e.g., professional talent needs may be short- or long-term and may be a single talent in one location vs. teams of experts in multiple locations worldwide. Professional insourcing involves providing specific, individual talent experts to support their clinical research project deliverables. An added benefit is allowing a sponsor’s managers to focus on their core business and other team deliverables. 

 

2. Cost-effectiveness  

The FSP model helps sponsors improve cost-effectiveness by enabling up to 30% more work for the same cost. By outsourcing non-core activities to the FSP service provider, sponsors benefit from budget predictability and reduced infrastructure costs. Other advantages include the lower risk of change orders (due to set costs), which simplifies forecasting. FSPs also accelerate timelines, improve market access, provide quality management oversight, and improve pricing predictability. Furthermore, sponsors benefit from lower turnover rates and better team continuity.   

 

3. Access to specialized expertise  

SRS providers leverage their industry experience and international network of screened and qualified professionals to identify specialized expertise that best matches the needs of sponsors and their projects. 

 

4. Improved efficiency and timeliness  

The FSP model facilitates long-term relationships that develop greater efficiencies over time and provide a single functional service to a sponsor, often across multiple programs, to maximize resource utilization. Additionally, sponsors benefit from increased control and oversight of deliverables, reduced risk of underutilization, and cost-effective contract rates.  

 

TFS CRO: Your Partner in SRS  

TFS HealthScience provides customized global resourcing solutions that enable organizations to manage clinical trials better. Leveraging our resourcing solutions, sponsors benefit from resource flexibility, access to experts and skilled resources, team and management efficiency, cost efficiency, and the ability to focus on their core business and outcomes. We find people who have the skills to move your project forward and also fit the structure and culture of your business. 

 

Professional recruitment services  

TFS provides professional recruitment services for permanent hires with global expertise across all phases and therapeutic areas for all clinical development functions and at all experience levels and competencies. TFS knows the clinical research industry, understands customers’ needs, and can select the best candidate to support a customer’s clinical development journey.  

Professional insourcing 

TFS delivers quality through our talented professionals, intelligent processes, and deep technical expertise. We offer professional talent for short- or long-term support, ranging from a single resource in one location to teams of experts in multiple locations and countries. Specific, individual talent experts support and enhance our clients’ project deliverables, allowing their managers to focus and control their core business and team deliverables.

Functional service provider (FSP) model 

TFS provides FSP services for sponsors wanting to explore an embedded team model across all clinical functions. TFS provides fit-for-purpose FSP solutions uniquely tailored to each customer’s needs with a fully integrated and dedicated team to offer enhanced quality, flexibility, and sustained efficiencies.  

 

Conclusion 

The clinical research industry has faced pervasive issues across the workforce, which are likely to intensify in the future. To prevent disruptions in clinical research, research organizations leverage SRSs, which provide customized people-based solutions that fit their needs, e.g., in a timeframe (short or long term) and scale (single talent vs. managed teams).

TFS SRS expertise is built on years of experience combined with in-depth knowledge of our customer’s objectives, products, procedures, and systems and an understanding of future trends. Bringing together nearly 800+ professionals, TFS strategically supports both international and local sponsors in more than 40 countries, enabling them to expand their reach and supplement their projects with selected services to meet their requirements at any phase of the study. By partnering with TFS, sponsors can access tailored clinical research services with flexible clinical development and SRSs across key therapeutic areas, including Dermatology, Immunology & Inflammatory Diseases, Internal Medicine, Neuroscience, Oncology & Hematology, and Ophthalmology. 

Visit our website, check out our TFS strategic resourcing solutions, or connect with a TFS representative today!