Clinical Trials Arena: What is the Earned Value Management system and can you explain why it was developed?
Stephan Aufhammer: Earned Value Management (EVM) is able to provide accurate forecasts of project performance problems, which is an important contribution for project management. The homemade Budget Tracking Tool (BTT) is an EVM-based reporting system that’s simple and assesses output deliverables. Since it is a very flexible tool, it can be applied to clinical trials as well. We developed this system mostly to implement a reporting tool that satisfies the user (the people involved in the clinical trial) as well as the needs of upper management (in terms of evaluating performance, achievements and budgeting planning).
CTA: How has this reporting tool simplified processes within your organization?
SA: Normally you have a study manager responsible for planning timelines, for scheduling, milestones, and reporting on budget. That can be an arduous task because you’re constantly reviewing how many invoices have been spent, which are still outstanding, how much you would spend in one fiscal year and the following fiscal year, and so on. You have to report on what you did, what you missed, what is delayed, and so on, all of which is time consuming.
If you have a big company conducting several clinical studies at the same time, that stretches your capacity to the limit. In using this new program, you can report and reconcile budget information more efficiently. It also enables you to anticipate any complications that could arise in the future, helping you to realise the process performance.
CTA: Has this tool helped lower costs in drug development?
SA: It has saved us costs in terms of the use of resources. It is an efficient tool because you can have early information on monthly spending on projects, meaning you can reassign money to other projects that need the money. This is all done automatically and on time. Every day you can have a tool that can not only be used quarterly or once a year, but on a daily basis. So here we have a system that helps you determine which program, which phase of study will not spend the money in that time, or which will overspend the money, and how much money can be saved and shifted to the next fiscal year. Conversely, this is not simply a cost saving mechanism, enabling you to plan your budget – it’s a system that allows you to gauge performance levels and milestones of the study. In this sense it is also an indirect risk detection system.
CTA: This appears to be a multifaceted reporting system that allows you analyse all aspects of the drug development process. What in your experience have you found to be the drawbacks in using this system?
SA: No, there’s nothing we can’t analyse. Recently, we rolled it out to the US and Switzerland .Initially we tested it on just clinical trials, before extending it to the whole organization across different type of projects or even maintenance activities (patents, regulatory licenses).
CTA: What was the initial feedback from participating affiliates?
SA: Of the companies we rolled this program out to, we had positive feedback from the various finance departments, R&D departments and Controlling. For a small company, it’s not always easy to have internal projects, so it has to be effective to the user. I think users are always happy if they can work on their real projects and not waste time on administrative reporting, or reconfirming budgets.
CTA: Would you consider this tool to be a success?
SA: This application was something that was borne out of a desire to improve science reporting. The question we asked ourselves was: How can we make reporting easier and more efficient? It was our intent to create a reliable tool that simulates reality more effectively than relying on actual data and planned data. It gives us greater transparency behind what the numbers are, and it enables you to assess all the various aspects surrounding the study, but importantly the performance levels of the company.
*Stephan Aufhammer is the Project Leader Filler & Medical Devices at Merz Pharmaceuticals