As large pharma, biotech, and medical device organizations feel the economic pinch of escalating costs, stricter regulations, and fiercer competition, many are seeking new ways to cut the costs of development in the face of decreasing margins.
One of the largest costs to address is staffing, including the cost of attracting, hiring, and training personnel.
For clinical trials, two common trial management approaches have been employed over the years. One approach involves running the entire trial internally and outsourcing only specialized parts of the trial (such as lab testing work or investigational product supply). On the other end of the spectrum is the use of Contract Research Organizations (CROs) to fully outsource a complete trial.
However, a sponsors desire to maintain a high degree of control over clinical trials without being responsible for directly staffing each individual function, drives a third approach that uses vendors as Functional Service Providers (FSPs).
This is where specific parts or functions of a trial, such as clinical project management, clinical research associate teams, data management, or biostatistics and statistical programming functions, are contracted as a scalable service and reduced or discontinued when the need has passed.
FSP is a trending and innovative staffing model that moves with the ebb and flow of an organization’s innovation pipeline. It can materialize in many forms, from individual specialists to functional departments, depending on the sponsor or portfolio requirements. It can manifest as a resource driven billing model or be designed around unit deliverables, or a hybrid of both approaches.
By outsourcing tasks by function or department, organizations boost operational efficiency and flexibility, thus giving managers the time to focus on their core mission. The FSP model also enables the sponsor to retain control over trial management in a fully flexible and scalable way.
Other benefits to FSPs include a reduced employment burden such as attracting and hiring talent, termination of employees, and day-to-day staff management, while providing sound integration with the existing functions of the company.
So, can the same benefits of the FSP model for clinical trials be realized on the laboratory data management side?
Cleaner data, faster
A growing feeling among sponsors suggests that labs should evolve with the clinical side of individual studies and provide fast resolutions to queries and urgent data management tasks, such as laboratory specialty data reporting.
To answer the call, leading research and development services company Covance launched Lab FSPx in August 2019. Lab FSPx is a laboratory data management solution that expands the Covance FSPx portfolio, complementing its clinical operations, clinical data management, medical writing, biostatistics, and post-market vigilance capabilities. Lab FSPx is a highly focused service that draws from the unique combination of laboratory and data management expertise across the Covance organization.
According to Manish Soman, senior vice president FSPx, safety and regulatory at Covance: “Historically, sponsor data managers have been responsible for lab data, along with clinical data and all types of external data.
“As clinical studies have become more complex, we have replaced the need for sponsors to directly oversee all of these areas, with a specialized outsourced role delivering trained specialists who have a strong understanding of lab data. With this process, sponsors get cleaner data, faster.
“Covance has delivered an FSP model for 30 years, providing dedicated resources that are either remote or embedded as an extension of a sponsor’s internal staff. Currently, 96 different functional relationships exist, each addressing a client’s required specialized skillsets.
“Over the past four years, we developed a specialized role that is now offered through our new Lab FSPx that focuses on external lab data and the variety of data management tasks needed to integrate biomarker data, safety lab data, and any other sources.”
Experienced data specialists
With Lab FSPx, clients can better manage laboratory data acquisition, data transfer, data transformation, data reconciliation, and site interactions.
By combining Lab FSPx with a client’s central laboratory data team, sponsors are often able to complete study start-ups faster by implementing standards, lean processes, and blended roles. In fact, an increasing number of sponsors are turning to the FSPx solution as they seek to reduce costs and data reconciliation processes.
When Covance is the central laboratory, sponsors can add to the Lab FSPx service by incorporating streamlined processes for data reconciliation that eliminate bottlenecks and directly access the necessary data stores. Because Lab FSPx also has access to eCRF records, the result is improved start-up, smoother data management during trials, and faster data reconciliation.
In leveraging experienced data specialists and clinical programmers, clinical teams can effectively manage studies with a range of laboratories, including central, local, and specialty labs via Lab FSPx. This is particularly important in biomarker-rich studies where data is often very complex and there are multiple external labs delivering data.
Essentially, clients gain an end-to-end solution to help them better manage their laboratory data management operations with the Covance Lab FSPx model. Sponsors benefit most from being able to depend on having their data the way they need it, when they need it, via a scalable, outsourced solution.