By Deb Borfitz
April 20, 2009 | Portfolio-level operational planning has been an industry trend over the past two years, but the cumbersome undertaking just became much easier for several clinical development organizations. Relief arrived with an upgrade to the recently launched Enterprise Edition of ClearTrial’s clinical trial software (version 2.7), which takes cost and timeline forecasting from the protocol to the portfolio level in minutes, says CEO Mike Soenen.
Portfolio planning has become a major time consumer for revenue-pressed companies, particularly those that are also eying in-licensing and out-licensing deals for corporate development purposes. Until now, the best way to achieve a view across entire study programs or business units was generic portfolio-planning software that leaves the work of compiling task lists and calculating resource requirements to their exhausted, often befuddled users.
ClearTrial Portfolio Planning has “embedded clinical intelligence” and speaks to users—including folks in clinical operations and outsourcing—in their familiar clinical language, says Soenen. By virtue of the questions it poses, the software forces companies to think about their big cost drivers.
Importantly, the software automatically updates portfolio forecasts whenever changes are made to protocol-level assumptions, giving visibility to the big-picture impact on cost, resource requirements, cycle time, and milestone dates. This is a chore that would otherwise consume at least a half day’s time of a seasoned professional, Soenen notes. “These people have day jobs. They want to wrestle with portfolios, not software.”
Customer experience suggests that the updating feature alone can save a mid-size pharmaceutical company, making eight changes to each of 15 studies, about $250,000 annually in salary costs alone, Soenen says.
Strategically speaking, ClearTrial Portfolio Planning can help company executives make more rapid, informed decisions about which clinical studies to fund or drop by providing an accurate view of costs and when they occur. It also allows organizations to quickly and easily know the cost of acquiring a promising compound as well as create what-if scenarios based on the probability of the purchase relative to another licensable product. For licensing deals, some companies have been hiring consultants to run the numbers and waiting two weeks for results.
From an outsourcing perspective, the software gives companies the “operational readiness” to strike portfolio-level deals with clinical research organizations (CROs), says Soenen. A color-coded timeline of monitoring tasks, when viewed across studies, makes significant overlaps readily transparent. Once companies can see that site visits for different studies will happen at the same time and in the same geography, they can negotiate for full-program discounts with a CRO based on the fact that it can better leverage monitoring trips.
Additionally, ClearTrial Portfolio Planning has the obvious benefit of helping R&D finance experts quickly produce monthly spending reports to their company’s board of directors, says Soenen. If layoffs are necessary, the software can point out if there are too few remaining study monitors for the planned study volume so decisions about outsourcing can be tackled well in advance of the need.
“Overall, it’s a compelling proposition,” says Soenen. “We have more business than we can handle right now, in terms of opportunities on the sales side. We expect 2009 to be a very good year for us.”