How to modernize your clinical technology team for a digital future

Too much demand. Too many options to choose from. Too much reliance on vendors.

Sound familiar? These sentiments certainly were for a recent ZS client, a newly hired vice president of clinical development technology at a major life sciences company. She sought our help building a business case for increasing her clinical solutions staff by 25 full-time equivalents (FTEs). In her new role she was charged with getting a firm handle on her team’s approach to vendor management, reviewing their approach to data, coordinating with other teams working on analytics for clinical trials and diving more deeply into biostatistics.

Our work for the client, which ultimately helped secure the investment she needed, involved a landscape review and industry benchmarking, including discussions with a broad array of clinical technology leaders across the industry as part of our quantitative research. These exercises revealed that the client’s team members were overseeing significantly more vendor personnel than organizations of comparable size. Our findings also resulted in a set of specific recommendations for the client, as well as advice for others grappling with the digital transformation sweeping through life sciences organizations. Before we jump to our recommendations, we want to share some observations on the current environment and the state of “good problems to have.”

• Too much demand: The pandemic accelerated the need for digital technologies in the clinical development space unlike anything the industry has seen before. While the technology needs of decentralized trials are getting the most attention now, the ongoing need for more efficient studies is driving the uptake of digital elements, from data lakes to analytics platforms. Requests for the insourcing and outsourcing of new products and services usually ends up flowing to the CT team.
• Too many options: Given that demand only seems to be growing and that solutions now need to cover numerous new indications and phases of development, study teams have more digital solutions to choose from than ever. In their well-intentioned efforts to choose the best solution for their need, teams are inadvertently creating a wild west at the enterprise level with too many technology platforms to manage.
• Stretch ratios of vendors to FTE personnel: In line with the increasing number of technology options under exploration, slowly expanding internal teams are having to lean harder on vendor partners for headcount. While vendors will continue to play an important role in CT, enabling benefits of fast ramp ups and ramp downs, close working relationships with internal personnel are critical for several reasons. Internal personnel are important for clarity of requirements and the retention of ongoing knowledge management. In our research, most FTEs were managing between three and eight vendor personnel. However, one client was managing vendor personnel well into the double digits and was seeing commensurate decline in quality along with general performance issues, which cost the organization millions and led to years-long delays. 

In developing a path forward with the client, we put detailed thinking into both the immediate FTE-to-vendor ratio disparity and the corresponding operating model for long-term success. Looking down the line, we worked with the client to identify their most likely digital path in the next two to three years and tailored our recommendations to pull this vision through. Many of the items the team will be focused on align with ZS’s mission to put patients at the heart of how trials are conducted.

We know that our client’s challenges echo what other leaders in this space are confronting, so our advice for her can be applied broadly to leaders in similar situations. Our recommendations, which we view as how-tos, emphasize change management, modernization and prioritization.

1. Elevate your voice in decision-making where there are digital implications: Elevate the branding of your team in the eyes of global development and therapeutic area leaders. Bring a clear value proposition that illustrates depth of partnership, shared outcomes to target and a crystalized role that CT can play with their study teams.
2. Use this elevated voice to set clear goals and priorities that ladder up to them: With global development and therapeutic area support, create a validated list of targeted digital goals and a prioritized list of actions that will be used to achieve them. In tandem with this, set a governance process that reduces the number of changes in the direction the team will take. As CT usually sits within IT, avoid creating the perception that it’s “so hard to work with IT” that a temptation to form a shadow organization emerges. Ensure that business and science personnel are comfortable with IT and have taken ownership of a set of priorities with which they are aligned.
3. Target total team size and a sustainable FTE-to-vendor ratio to support these priorities: Once you have a clear path of prioritized actions and targeted outcomes, share them with the science and business teams. Then establish what the appropriate near- and long-term team sizes are and structure them for success. While there is no single right answer to the FTE-to-vendor personnel ratio, in general a ratio greater than 1:8 appears unsustainable over time. We recommend conducting internal and external research annually to validate a high-level roadmap and commensurate team sizing based on portfolio needs. This should be shared, in a transparent manner, with business and science leadership to ensure support for the right technology resourcing team.
   

In an age when the lines between business, science and technology are blurred, CT leaders must have a strong understanding of their organization’s priorities and plan investments accordingly. Initiatives to advance patient centricity, reduce clinical trial timelines and launch decentralized trials will require CT teams with an array of skill sets. Vendors can play a key role in helping to quickly scale up these skill sets as long as the proper investment and staffing strategies are in place.