Clinical Project Mgt.: Why It Matters More Than Ever

By Mike Soenen

In life sciences, clinical project management is often more art than science, and as a professional, scientific discipline it has yet to achieve the same level of acceptance as in other project-intensive industries such as construction and aerospace. This is partly because traditional software tools for tracking project status are either cumbersome to use or incapable of detecting problems in their early, treatable stage. It’s also a matter of economics. Variances in project status and cost have not, until relatively recently, received the same attention as other aspects of the R&D process.

With more competitive pressures and cost scrutiny than ever before, clinical development efficiency is the order of the day. Project managers have been tasked not only with moving products through the pipeline but also doing so in proximity to estimated timelines and budgets.

The economics issue is taking care of itself. As for the technological question, sophisticated software now exists that blends the pillars of project management — accruals management, project status tracking, trends analysis, and reforecasting — into single, easy-to-use systems. The technology itself ensures adherence to four accepted “best practices” for managing clinical projects:

Eliminate The Uncertainty
Pharmaceutical companies have embraced the tracking of metrics, but often don’t have a clear idea of what they’re tracking against. Intelligent project management begins with an accurate up-front plan covering the assignment of responsibilities and definition of timelines and objectives, deriving estimated costs from the required work effort. Companies then have a vantage point from which to view schedule and cost variances once the project gets underway. Many study sponsors today still use budget tracking to assess project status over time. Such measurements are inconclusive at best because they fail to consider what specific work has been done for the amount spent. A proven project management methodology known as Earned Value Management (EVM) fills the knowledge gap. EVM informs companies how well-planned work is being accomplished, if it is being accomplished on time, and how closely project cost matches the budget at any point of time as well as at completion.

Know What You Owe
Accruals management represents a historically painful aspect of clinical project management, owing to the complexity of the work and the often irregular pace with which work gets done. Increased outsourcing to functional service providers has only enlarged the blind spot. Given accurate and up-to-date accruals reporting, CEOs and CFOs need not dread what figures will pop up as assets on vendor balance sheets. If a company’s clinical management software incorporates EVM principles, project managers and finance managers will have quick visibility to amounts owed to service providers for work performed and whether work gets done on time and in conformance with the contract.

Know Where You’re Heading
Cost and schedule bottlenecks can’t be proactively identified and addressed unless project trends are visible to all key stakeholders (e.g. How far below or above budget are project costs at any one time? Is planned work behind or ahead of prescribed timelines?) Clinical development software with project management best practices “baked in” can provide life science executives with an early warning about key performance issues — for major tasks as well as for an overall study — without having to understand anything about information technology or accounting. It also simplifies (perhaps even eliminates) the reporting process for the time-pressed folks in clinical operations, allowing them to remain focused on critical tasks within their areas of expertise.

Reforecast As Necessary
Transparency about study progress can alert companies to needed changes in the initial project plan, giving them an opportunity to easily “course correct.” The cost of implementing those changes can then be immediately factored into final cost calculations, eliminating unwelcome and embarrassing surprises on year-end financial statements.

The motivation is there. The technology is there with the necessary clinical intelligence and best practices built in. And in today’s economic climate, there is a compelling reason for the life sciences industry to make professional project management principles a part of every study.

Mike Soenen is president and CEO of ClearTrial, a provider of software for clinical operations planning, outsourcing, and project tracking. His 20-year career has focused on providing life sciences, manufacturing, and distribution companies with efficiencies in project management, supplier relationship management, complex pricing, contract management, and customer relationship management.