With the increase in novel trial designs, an increasingly complex research landscape and related costs, the pharmaceutical industry needs to work faster, leaner, and smarter to keep up with the pace of innovation and drive patient outcomes forward. Trial sponsors are increasingly leaning on functional service providers (FSPs) to deliver with additional efficiency, speed, and precision throughout the clinical development process.

As drug development continues to evolve, trial sponsors may want to have a broader discussion with their FSPs to determine what elements of trial design and execution can be managed by these valued partners, who may have specialized expertise and scalable processes - and technologies - to meet or surpass trial program goals. Clinical monitoring is commonly outsourced, but trial sponsors can also consider outsourcing project and line management across a broad range of functions including Statistical Programming. Outsourcing project oversight and line management responsibilities has several benefits for sponsors who are feeling the impact of delivering to tight timelines with reduced resources.

Strong project oversight

Turning to FSP partners for project oversight can be helpful as they have in-depth knowledge in various areas such as:

• Specific therapeutic area knowledge and expertise
• Development and oversight of project plans
• Resource planning
• Clinical development processes and related logistical needs
• Regulatory requirements
• Risk management
• Building and retaining high performing teams

When considering whether to outsource project oversight needs, sponsors should keep in mind that while they have internal staff who have experience in overseeing clinical trials, is this the best use of this resource? A typical FSP will have staff who have a deep breadth of experience at project oversight, having worked across a large number of different clinical trials, often for several different sponsors.

FSP project managers in statistical programming can help with effective resource planning and proactively flagging future gaps to the sponsor. Given their experience, they also know what’s required from programming and can devote time to thinking about developing necessary skills that align to the sponsor’s strategy. For example, a sponsor may be keen to implement the use of R programming to deliver the CDISC datasets and Clinical Study Report (CSR) outputs. The project manager can help drive this specific strategy by supporting staff with the required training and utilizing their experience with other sponsors to facilitate a smooth implementation—increasing efficiency to reach sponsor goals.

Strong line management

In taking a closer look at how to ensure efficiencies throughout the trial, sponsors may consider strengthening line management operation. It’s vital to know what skills and processes are required (and potentially lacking) for each program to ensure trials are running at their best. FSP line management experts can identify the staff that have the skillsets to meet the portfolio needs and to upskill additional staff for any gaps. They will ensure staff receive ongoing training and development to meet the needs of the sponsor as well as to ensure they keep up to date with new regulatory requirements. They can coordinate training and onboarding and oversee adjustments accordingly.

They can also provide specialized trainings to help team members gain appropriate skills for the sponsor’s individual trial needs. For example, within a statistical programming FSP model innovative training can be given around programming standards and languages such as CDISC, R or PYTHON and how to apply them to the creation of CSR deliverables. In addition training can be provided in more specialized tasks such as the creation of scripts and macros to facilitate the automatic execution of repetitive tasks.

Additionally, career experience matters. FSP line managers in statistical programming generally have a programming background. They understand the programmer’s role and challenges and can confidently talk from a position of authority, while providing mentoring and support when timelines need to be negotiated or pushed back. Knowing their team’s skills well, these experts can adapt quickly to shift resources as needed, as they can anticipate upcoming challenges and risks.

Staying current on regulatory requirements is critical in today’s landscape and FSP line managers can help guide the sponsor in its strategy. For example, FSP line managers can advise sponsors on how to ensure they meet the latest submission standards and requirements for the various regulatory agencies.

Outsourcing the time consuming regular ongoing activities at the “brass tacks” level such as performance management and approving employee timesheets and project expenses to FSP line managers can be beneficial. Managers within pharmaceutical and biotech companies can then focus on enhancing their own skills through work that adds value to the business.

Lastly, FSP line managers understand the importance of open and regular communication with their sponsor. Strong line managers will hone in on the inner workings of a customer, including its requirements and standards of working. They can then share the relevant client information with their direct reports at the right time, ensuring it is shared across the team, without the need for the client to get involved.

The clinical development landscape will only become faster, more complex and costly. Hence, demands placed on pharmaceutical and biotech companies are high. Sponsors should consider outsourcing both project oversight and line management responsibilities as part of a working FSP model to further heighten efficiency.

For questions or to learn more about outsourcing project oversight and/or line management, contact: GlobalFSPGTM@iqvia.com