Resource Management for Clinical Operations

To remain competitive today, Life-science organizations must prioritize the establishment of a central resource management capability. This allows them to use their resources efficiently by applying a consistent and strategic cross-functional deployment.

Current Trends: Resource Management Implications

Rapid advances in the life-sciences industry are improving patient outcomes, but are also increasing trial cost, complexity, and duration. These trends have increased pricing pressure from governments and payers, and brought new scrutiny to operating costs. Both factors have motivated research and development (R&D) leaders at organizations of all sizes to evaluate their operations, especially the core capability of resource management (RM).

R&D leaders must be able to separate myth from fact when assessing their organization’s workload, capacity, and capabilities. The value of effective resource management is straightforward. It enables organizational leaders to identify and address issues proactively in the dynamic landscape of resource supply and workload demand. Robust RM allows managers to ensure they have the right number and types of resources with sufficient bandwidth to support R&D operations. Good RM means being able to get the right people to the right place at the right time.

Dramatic changes have occurred in the past decade with respect to trial execution. Ken Getz of the Tufts Center for the Study of Drug Development examined trends in clinical trial design and execution from 2001-2015. He had a focus on elements of study design associated with “executional feasibility” (e.g., number of procedures performed, planned number of visits) and the associated work effort. Getz’s research uncovered significant growth in a troubling combination of measures: trial complexity, cost, and execution time.

The number of procedures called for in protocols has risen as much as 70%, and costs have soared between 34% and 67% from 2001 to 2015 across trials in phases I, II, and III. This has increased cycle times and instances of protocol amendments which add complexity. These factors take a toll on R&D staff as they struggle to adapt to rapidly shifting demands. In turn, this leads to longer study durations and delayed regulatory submissions.

In this type of environment, an understanding of total capacity and effective resource deployment are essential, as organizations are forced to do more with fixed resources.

Common Issues

Three forces that contribute to clinical R&D organizations’ frustration with existing practices are inefficient processes, inadequate infrastructure and tools, and limited ability to identify and address underlying reasons for such inefficiency.

• Inefficient Processes – Resourcing practices are decentralized with redundant tracking efforts across functions. Resourcing information comes from many sources and requires significant effort to consolidate, interpret, and analyze
• Inadequate Tools & Infrastructure – Resourcing tools do not support proactive management due to functional limitations, or poorly defined operating infrastructure. As a result, tools do not enhance organizational visibility and are difficult to manage day-to-day
• Limited Visibility and Value – Tools/reports do not give leadership insight into resource demand and capacity. They also inhibit managers from translating information or considering broader strategic goals when making resourcing decisions. As a result, resourcing decisions may fall out of alignment with upcoming workload demand and organizational priorities

Due to the commonality of these root causes, issues manifest themselves in similar ways across clients. Typical issues include decentralized RM practices comprising a variety of function-specific tools, data sources, and calculation methodologies. In these situations, the reliability of forecasts and value of insights are limited due to inconsistency in analytic approaches and quality of data.

These inconsistencies represent just some of the challenges in consolidating disparate source data into a single, standardized view of resources across functions. Another scenario we frequently encounter is an established central resourcing process supported by internally developed resourcing tools. In this case, the goal of reporting to client leaders is well-intentioned, but the output falls short of driving value.

Growing Pains | Developing Resource Management Maturity

Simple reporting tools, although expedient, tend to offer inconsistent utility and limited actionable insights. Because these solutions are frequently labor-intensive, the effort-versus-value equation is oftentimes out of balance.

Scenarios like these are all too familiar, and often follow a common evolutionary trajectory. The early stages of developing a robust resource management capability can feel like stepping into the plot of a Western movie—a new frontier fraught with challenges and lacking the structure and order afforded by government and laws. Significant effort is required to tame the “wild west” of disparate data, inconsistent practices, and limited visibility. In our experience building and improving our client’s RM capabilities we have observed a common pattern in the development of mature RM practices.

Common Scenarios

Stage I | Decentralized Resource Management – The decentralized resource management model is marked by inconsistent processes with respect to data collection, synthesis, and reporting. Functional groups are left to develop their own approaches for assessment and analysis. Responsibilities are disaggregated across functions, requiring redundant resources to analyze and generate reports for each functional area.

This stage presents numerous challenges for senior leaders, as inconsistencies in the assumptions, analytical rigor, and data quality may prevent accurate cross-functional comparisons. In many cases quality checks of the information take a back seat to competing priorities, leaving errors unaddressed and improvement opportunities unrealized.

Stage II | Centralized and Optimized Resource Management – This is the ideal organizational model. The company has matured practices and infrastructure to support operational efficiency in collecting, analyzing, and monitoring resourcing data across constituent functional groups. A regular reporting cadence has been established to provide insights to leadership through a standard assessment approach. Feedback loops are incorporated to solicit input from stakeholders and evaluate the accuracy of forecast algorithms.

Acquis helps clients at any stage of RM maturity navigate the challenges they face; our understanding of each client’s unique goals and priorities allows us to develop tailored solutions that deliver immediate value.

Engaging Acquis | Our Approach

Our core belief is that sustainable resource management includes three critical components: operating infrastructure, governance infrastructure, and a regular review process to assess the strategy and adjust as necessary.

End-to-end involvement is key to our delivery philosophy. By engaging clients closely from the outset, our consultants develop a thorough understanding at all levels. From the corporate goals, customs, and culture that drive decisions organization-wide, to the processes, procedures, and local nuances of functions within R&D they can do it all.

To develop a solution tailored to the unique needs and challenges of each client organization, Acquis leads several key activities, including:

Development of a comprehensive fact base: Our efforts include fact-finding activities such as documentation review, interviews and surveys with key stakeholders across functions, and more. These activities provide both an understanding of current RM practices, as well as insights into user requirements, unmet needs, and priorities.

Acquis works to gather insights from all levels of an organization to understand issues beyond the data. This approach enables us to quickly deliver actionable insights that address how and why the ongoing management of resources differs from a leader’s vision of the ideal.

Aggregation, synthesis, and analysis of information gathered: Our activities focus on analyzing and contextualizing data to understand how resources are deployed and the impact of factors such as clinical trial size or a number of patients. Acquis maintains a deep knowledge of industry best practices and prevailing trends to support the development of a robust resource-allocation capability that measures performance against benchmarks.

We work with client leaders to define the “core” responsibilities of different roles and conduct a thorough evaluation of their ideal state against the real world. This approach enables rapid identification of areas that unduly burden resources and reduce capacity.

Design and development of a resource-allocation model and reporting capabilities: Acquis frames key issues and insights from data collection and analysis efforts and collaborates closely with client leaders during the design phase to develop practical solutions.

Our collaborative approach allows us to validate findings, assumptions, and feasibility, as well as to cultivate client ownership and foster engagement in building the future state. Our work at this stage drives the development of key deliverables, such as:

• Customized algorithms: We create algorithms tailored by function and role using data gathered during interviews and from surveys

• Tailored reports: Our team leverages a variety of analytics platforms including Excel and Tableau to create fit-for-purpose reports and custom dashboards for functional managers and senior executives

Implementation and change management support for new resource management practices: The task of standing up an effective RM capability extends beyond design and development. Acquis helps clients successfully deploy solutions, taking them from PowerPoint into daily practice, ensuring immediate and lasting benefits to the organization.

Our hands-on engagement style gives our colleagues a deeper understanding of our clients and helps establish trust and rapport across stakeholder groups. Our teams seamlessly integrate with client organizations and draw on their project and change management expertise to support successful implementation.

Outcomes

Our RM approach allows us to deliver meaningful benefits to clients across three key areas:

Process & Technology

• Standardized practices for resourcing across functions
• Shared tools and processes to ensure consistent resource management
• Increased use of technology to enhance efficiency

Metrics and Reporting

• Optimized utilization of resource capacity
• Improved monitoring to ensure resources are utilized efficiently, for high-priority/high-value activities, and to forecast future needs
• Dynamic balancing of bandwidth/utilization levels to align available resources with areas of need

Continuous Improvement

• Direct feedback loops from employees via managers to resource management capability leads to make adjustments as needed
• Defined review cycles to support the continuous improvement of algorithms, tools, and processes

In our experience, removal of nonessential tasks increased resource capacity by between 5% and 20% depending on the role. This increase translates directly to cost savings for the organization because existing resources can support a growing organizational pipeline. By identifying the most important activities and assigning those activities to the appropriate roles, an organization can realize the true value of resource management.

Conclusions and Considerations

The concepts discussed in this paper can be applied to organizations of any size to assess and develop a customized RM solution. Life-science organizations that establish a centralized resource management capability can use their resources efficiently thanks to consistent and strategic cross-functional deployment. Acquis believes RM should be an investment priority for clinical operations to remain competitive today, and to emerge successful in the future.