In any clinical study, trial leadership at every level have an abundance of details to manage, people to supervise, deadlines to meet, and budgets administer, among other things. What trial leadership does not have is an abundance of time to solve the inevitable challenges that arise in relation to these various moving parts. Saama can help.
In our new blog series, “Saama to the Rescue,” we profile common, real-life challenges encountered by various levels of clinical trial leadership every day, and how Saama solutions can pave the way for more efficient and effective clinical operations. Our first installment focuses on a fictional Portfolio Lead in a start-up scenario.
Situation: I’m Anton, Portfolio Lead for Company X’s oncology therapeutic area. In addition to managing 10 studies in start-up - and all the associated challenges that go along with them - I was notified this morning that an urgent meeting was just scheduled for early this afternoon with senior R&D leadership who want to know if these studies are on track with their target start-up milestones.
Challenge: I need a comprehensive overview of the start-up status and trial landscape for Compound X, and a deep dive into the specific details for each trial so I am prepared to fully brief senior management and respond to any questions they may have. Talk about a last minute request. Two of my trial managers are on vacation, so I know I won’t be able to reach either of them for input. Did I mention I need this information FAST?
Solution: I log into Saama’s Life Science Analytics Cloud (LSAC) with its sophisticated filters and functionalities to do a quick assessment, and notice that protocol approval, MOH submission and pre-study visit dates are on track. However, red flagging indicates that six out of ten studies have site activation dates that are behind schedule and four of the studies are projected to be 15%+ above the budgeted amount, based on predictive modeling off the year-to-date spending. I click on the red color to drill down into the specifics of each study, and notice that of the 15 countries participating in Study #6, five (US, Spain, Belgium, Poland and Australia) are at least 20% behind schedule. I can immediately tell that Belgium, Spain and Poland are sitting on the higher side, about 30% or more from target. I click on each of these countries to see what is happening, and the data shows that only two out of the 6 sites in each country are on track. In the remaining sites, IRB approval dates have been delayed, resulting in site activation postponements.
I follow the same procedure for each of the other studies in my portfolio, and soon have a comprehensive and detailed picture of progress toward start-up milestones. I contact each of my trial managers to clarify any additional questions, then use LSAC’s “Create Power Point” feature to develop slides of the key dashboards. I know I’ll be able to toggle effortlessly between the deck and LSAC during the meeting to answer any questions from senior management. Feeling fully prepared, I get started on other business of the day.
Summary: With a few clicks of my mouse I am now positioned to provide a comprehensive and detailed report to senior management, despite the lack of lead time provided. I am also able to have a very informed discussion with my trial managers on the reasons for start-up delays and potential solutions.
Discover how LSAC can transform your day as a Portfolio Lead. Download the whitepaper from here.
To learn more or request a demo of Saama’s Life Science Analytics Cloud, click here. “Saama to the Rescue” will continue next week, when we take a look at the problems commonly faced by Trial Managers, and the insights LSAC can provide to inform quick and effective solutions.