By Todd Reul
Todd Reul is a director of clinical services for ClearTrial, a provider of clinical trial operations software. Reul has more than 18 years’ experience in the pharmaceutical industry, including 13 years in clinical research.
In today’s operating environment, biopharmaceutical and medical device companies are under increased pressure to be as efficient and cost-effective as possible. Establishing effective resource planning can go a long way toward helping companies achieve these goals by ensuring management has up-to-date, accurate insight into their resource obligations for a clinical study, now and in the future.
A good resource-planning process gives companies the tools they need to make insightful, strategic business decisions — enabling them to match the right level and mix of resources to a clinical project and across the project portfolio.
The result? Effective resource planning in clinical development delivers significant benefits:
reduces study risk by ensuring adequate resources are available and assigned when needed
lowers operating costs by utilizing resources more efficiently
improves long-range planning by enabling earlier hiring/outsourcing decision making
increases employee morale and productivity through consistent utilization and advance notice of project timelines and duties.
THE FOUR PILLARS OF EFFECTIVE RESOURCE MANAGEMENT
The most important aspect of resource management is to recognize that it is a continuous process involving multiple components. There are four key components, which I refer to as the “Four Pillars of Effective Resource Management”: resource planning, portfolio management, tracking project progress, and reforecasting.
The process of determining a resource demand projection for an individual project.
The life sciences industry is moving away from a reliance on spreadsheets and educated guesses to a methodology widely used in other industries for accurate resource planning — activity-based planning. Activity-based planning begins by deriving the level of effort for a specific resource to perform a given activity and when the activity is to be performed. Resource planning in this manner is sufficiently detailed to account for estimates on not only how many resources are needed (by role), but also when and where they are needed.
The process of rolling up individual projects to allow for global assessment across multiple projects.
Portfolio management is critical to resource management because an organization typically has multiple projects going on within a single resource pool. Portfolio management allows for the global assessment of all projects from many perspectives. From a resource management perspective, an organization will be able to determine resource utilization and thus make more informed staffing/outsourcing decisions. In addition, portfolio management also gives a company the global perspective of what the organization is trying to accomplish, thus empowering strategic decisions as well.
TRACKING PROJECT PROGRESS
The process of acquiring real-world data in order to gain the insight needed to assess the project’s progress and make informed business decisions.
Tracking a project’s progress over time can be accomplished in many different ways. However, it is important to limit the information being tracked to actionable data. Limiting the information gathered on a regular basis to actionable data, as opposed to informational data, helps focus attention on what really matters to the success of the project while also helping avoid the pitfall of data overload.
A best practice in this regard is the use of earned value management. Earned value management is a proven project management technique for measuring project performance and progress in an objective manner, providing visibility to a project’s current scope, schedule, and cost.
The process of updating project projections (timelines, budget, resource demand, etc.) to account for actual progress and/or project changes.
Reforecasting should be done on a regular basis based on the pace of change in the project and the organization’s standard business processes. While frequency of reforecasting will vary, it is critical in keeping resource demand current especially in long-term, fast-paced clinical studies. When in doubt, it is recommended to reforecast more often than not; quarterly or semiannually is recommended.