A program-level view allows users to get to the bottom of mid-study, and potentially, trial altering requests in a more time conscious manner.
ClearTrial just announced its Portfolio Planning software product this past weekend. Applied Clinical Trials was fortunate enough to have Mike Soenen, managing partner for the Westmont, IL-based company, stop by our offices and introduce this offering to us.
Let’s start by saying “software” is really not the best description of what Portfolio Planning accomplishes. Software brings to mind something that comes in a box. Excel, Word, and Project come in a box, but don’t really have the power of ClearTrial Portfolio Planning. To be fair, those Microsoft products are fine for what they do and for what they were designed. But applying project management and spreadsheets to the current needs, complexity, and sophistication of the pharmaceutical industry has become a time-consuming process unto itself.
The way Soenen explains it, many a clinical operations director or manager spends a lot of time forecasting, predicting, and changing trial cost expectations for upper management. These senior members, charged with directing the lifeblood of the company’s drugs through trials, are spending valuable time in the “churn of chasing spreadsheets.”
What ClearTrial Portfolio Planning does is take these “what-if” requests and literally boils them down to a mere few seconds per query, and on a portfolio management level. It rolls up the numbers, in a scalable way, and generates the scenarios needed. These visible scenarios include monthly budgets, monthly resource demands, and timelines across a program, business unit, therapeutic indication, region, service provider or any other assumption.
Soenen said that the company began developing the portfolio feature in late summer and fall of 2008. However, the ClearTrial Clinical Trials Operations Planning software has been in existence since 2004, providing the capability to budget, forecast, and plan on a clinical study level.
Ready to Hear the News
After two years of “evangelizing” and softly suggesting to industry executives about the necessity for this program or portfolio level capability, Soenen believes that a number of factors have converged that will help spread the word of Portfolio Planning. Those factors are: the economy, pharma trend toward outsourcing on a program level to CROs; a need to reach more collaborative consensus not only between pharma-CRO spending, but also between clinical operations and procurement.
How can software build consensus? With the next-to-instantaneous ability to forecast, users can see the effects of what is being changed. For example, internally, clinical operations can see in a graph format what would reductions in monitoring visits on a study or global program actually mean. Hopefully, this visual helps form consensus and the parties can agree that a monitoring reduction would not impact their “standard” timeline of monitoring and would not negatively impact the science or integrity of the study.
Externally, between pharma and CRO, the software flags certain assumptions, which can be helpful especially during the bid and RFP process. These flags can be taken back to CRO (or vise versa) for a more collaborative approach to developing program expectations. In addition, a pharma company can roll up the 10 studies it is providing to the CRO in a program-level view using the service provider assumption.
The three primary users of the Portfolio Planning product are high-level clinical operations (VP, Director); R&D finance group and Corporate Development, responsible for the in-licensing and out-licensing opportunities. Portfolio Planning is available with the Enterprise Edition of ClearTrial Version 2.7.