TFS HealthScience (TFS) has been a leader in providing comprehensive clinical research services for nearly 30 years. At the forefront of our clinical research operations is our Strategic Resourcing Solutions (SRS) division, offering tailored, global resourcing and flexible, functional solutions for clients’ unique clinical operational staffing challenges.

We recently sat down with Mike Coon, Business Development Director, Strategic Resourcing Solutions (USA Head), to discuss how TFS’s approach to strategic resourcing sets us apart in the industry. This article sheds light on the key benefits, differentiators, and success stories of our strategic resourcing solutions. Read on to gain insights from Mike into how TFS approaches strategic resourcing.

1. What are the key benefits of working with an embedded resourcing team as part of a full-service CRO like TFS?

TFS HealthScience’s SRS division offers clients tailored solutions for their unique clinical operational staffing challenges. Each situation is unique, and we provide a personalized approach to finding the right experts. This helps improve efficiency and ensures studies are completed on time and within budget. Whether there is a need for an embedded team of clinical research associates (CRAs) or study coordinators (also known as clinical research coordinators), in a new geographic region or a group of data management experts to close out a study database, TFS has been supporting these needs and enhancing study outcomes for over 26 years.

2. How does TFS’s approach to Strategic Resourcing (SRS) differ from other resourcing models?

While we can’t speak to the specifics of all resourcing models, we can highlight what makes TFS unique. Our Strategic Resourcing Solutions (SRS) offer customized global resourcing that enhances the efficiency, quality, and flexibility of clinical trials. Whether clients need a single resource or an entire managed team, we provide a tailored approach that meets their specific needs. Our services include professional recruitment for permanent hires and professional insourcing for short- or long-term support. This can range from individual experts in one location to entire teams across multiple countries, covering a wide array of clinical development functions such as clinical operations (ClinOps), project management, pharmacovigilance, biometrics, and more.

One of the advantages of working with TFS, as a mid-size CRO, is our ability to prioritize each client, regardless of the project’s scale. We have the staff, experience, and commitment to ensure personalized attention and support. Our proven process for rapid ramp-up includes rigorous screening and onboarding, ensuring that we provide not only skilled professionals but also individuals who fit seamlessly into our clients’ organizational structure and culture. This comprehensive approach allows us to deliver exceptional results, helping clients maintain focus on their core business while we support their clinical development needs.

3. Can you share a specific example where TFS’s Strategic Resourcing Solutions (SRS) made a significant impact on a clinical trial or project?

A multinational pharma company approached TFS for a Functional Service Provider (FSP) model, seeking to transition monitoring responsibilities from their current CRO. We developed a plan within four months that involved recruiting 23 monitoring support roles, including establishing line management, risk mitigation, and providing clear communication along the way. The result was a highly successful FSP team with low staff turnover, continuity, and study stability. The client was extremely satisfied, leading the client to expand TFS’s FSP/SRS support to other countries.

4. What common pain points do sponsors face when it comes to resourcing, and how can TFS help?

Sponsors often face challenges such as talent shortages, staff turnover, lengthy recruitment processes, training delays, and scalability issues. TFS helps alleviate these pain points by forming a close, trusting partnership with our clients. Our dedicated account managers and other TFS employees act as an extension of the client’s team, gaining an in-depth understanding of their unique challenges and needs.

Leveraging our extensive industry experience, network, and relationships, we are able to source the right experts for their clinical trials. We train these experts according to the client’s standard operating procedures (SOPs), establish and modify key performance indicators (KPIs) as necessary, and continuously monitor and adjust the team to ensure smooth and efficient study operations. This tailored, hands-on approach allows us to support our clients effectively, ensuring their clinical trials are executed with precision and excellence.

5. How does being a CRO ourselves give TFS a unique perspective in offering resourcing solutions?

As a global CRO, we share many of the same challenges and pain points as our sponsors, giving us a unique insider perspective. Our extensive experience in successfully managing hundreds of clinical studies across over 40 countries allows us to understand the complexities and nuances of clinical research. This deep understanding enables us to provide effective, empathetic resourcing solutions that are tailored to meet the specific needs of each project, regardless of its size. Our firsthand knowledge of the industry’s demands ensures that we deliver practical, reliable support to help our clients achieve successful outcomes.

6. How can specialized roles, such as study coordinators, improve the efficiency and success of clinical trials, and why is this a unique advantage that TFS offers?

At TFS, we truly understand that every role in a clinical trial can have a big impact. Whether it’s site monitoring, data management, or dealing with regulations, every team member plays a part in the trial’s success. One role that sometimes gets overlooked is the study coordinator, also known as a clinical research coordinator (CRC). These coordinators are crucial because they help keep everything running smoothly, on time, and within budget. Without proper coordination, even the best-designed studies can face delays and extra costs, which can impact the overall success of the trial.

Some sponsors might not initially see how important roles like CRCs are, but we make sure to highlight their value. We often bring in study coordinators for our fully outsourced projects because the CRCs handle the day-to-day operations that keep the trial on track. However, we are not limited to fully outsourced projects, which is where our flexibility is appreciated by our clients. This focus on specialized roles, especially in study coordination, is a big advantage we offer. It’s all about making sure our clients’ studies run as smoothly as possible and get the best results.

For more details on why study coordinators are so important, click here.

7. What other specific roles or positions do you find most beneficial for clients and why?

As drug development continues to evolve with new technologies and scientific breakthroughs, we at TFS are always looking to expand our range of expert roles to ensure our clients get top-notch support. For instance, we provide data management services through our partnership with Medidata, which is crucial for handling the complex data that comes from clinical trials. We also have experts in Real World Evidence (RWE), pharmacovigilance and safety, areas that are vital for tracking drug and patient safety and effectiveness in the real world.

On top of that, we offer specialists in regulatory compliance to help clients navigate the often tricky and detailed regulatory landscape, and we have talented scientific and medical writers who make sure all the documentation is clear, accurate, and professional.

Each role is important in its own way, and we make sure to tailor our support to fit the specific needs of each client, ensuring their projects run smoothly and successfully.

8. What kind of support and integration can clients expect from a TFS HealthScience resource or resourcing team?

Once the optimal model is determined, whether it’s a single resource or FSP, TFS ensures the staff has the proper training and oversight to fulfill their responsibilities. We collaborate with client stakeholders to ensure KPIs are met, study protocols are followed and documented, and modifications are made when necessary. We have a long history of successfully transitioning study responsibilities from other CROs to us. To minimize negative effects during these transitions, we routinely execute risk mitigation plans covering areas such as business continuity, study deliverables, Training, and corporate compliance.

9. How do you ensure our teams align with the client’s objectives and company culture?

From the moment a client reaches out to us, we start doing our homework to really understand who they are. We make it a point to listen carefully and get a sense of their mission, values, methodologies, and culture. We often find that we share similar passions, especially when it comes to advancing treatments that promote health and well-being around the world.

To ensure we’re always on the same page, we keep the lines of communication open with regular meetings, both virtual and face-to-face, with our clients, clinical teams, and our internal teams. This ongoing dialogue helps us stay aligned and ensures that our experts can seamlessly integrate into the client’s operations. It’s all about staying connected and making sure we’re working towards the same goals, from start to finish.

10. What feedback have you received from clients utilizing our strategic resourcing solutions, and how has it influenced our approach?

We’ve received a lot of positive feedback from our clients about our strategic resourcing solutions. For example, a program manager at a multinational pharma company recently praised our Senior CRA and Senior LSAD for their dedication and effective work. They highlighted how our team’s commitment and expertise led to a crucial database lock with no delays, even under tight deadlines. It was a great testament to our ability to handle challenging studies and deliver on time.

Additionally, this year we conducted a customer survey for our SRS services, and the results were overwhelmingly positive. Clients appreciated our commitment to quality, ease of working with us, and strong account management. They also expressed a high likelihood of continuing to work with TFS in the future. In fact, we received 90% positive feedback overall, which really underscores our dedication to providing exceptional service. This kind of feedback not only validates what we’re doing right but also helps us identify areas for further improvement to meet and exceed our clients’ expectations.

Conclusion

Though we may not be seeing the same boom in clinical trials as in 2020, the medical and clinical research field is still full of potential for innovation and discovery. Strategic resourcing plays a crucial role in this process by helping sponsors staff their clinical operations efficiently, ensuring that new therapies can move from the lab to the market. At TFS, our Strategic Resourcing Solutions (SRS) and Functional Service Partnership (FSP) solutions provide a comprehensive and customizable way to tackle the unique challenges within clinical research. Our deep commitment to understanding each client’s specific needs, along with our extensive industry experience, enables us to offer exceptional service and achieve successful outcomes.

As for Mike Coon’s thoughts on the industry’s future, he’s incredibly proud of the dedication and expertise our team brings to every project. He believes strongly in the positive impact our work has on advancing health and well-being globally. Mike is excited about the future of clinical research and looks forward to continued collaborations and new projects that will allow us to make even greater contributions to the field.