It’s no secret that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) is the most robust system in the space. But, as a Study Manager, what you might not know is exactly how it would make YOUR work life easier. Intrigued? Then, read on.
As a Study Manager, you have a complicated, stressful job. You are responsible for your study being on time, within budget, and, most importantly, compliant. If you personally ran all of the sites, it would be no problem. But, you have to rely on others, like physicians, in far-away places to do what they’re supposed to do.
Given that fact, it should be as easy as possible for you to manage the things that are actually in your control.
Enter Siebel CTMS, stage left.
Siebel CTMS was designed using a hierarchical data structure. This means that subject visits are nested under subjects, which are nested under sites, which are nested under countries, which are nested under a study. This nesting allows all of the data involved in a study to “roll up” to the study level. In other words, you, the Study Manager, only need to look in one place to find everything you need to know about your study – the Protocols screen.
In that screen, you can see enrollment graphs and statistics across all sites. You can also slice and dice the data by country, by site, by date range, by subject status, and several other factors to forecast whether you will meet your milestones on time. You can also dig into early termination reasons and screen failure reasons to identify trends, perhaps leading to a needed protocol amendment.
In that same screen, in Perficient’s Siebel CTMS accelerator, ASCEND, you have additional functionality for managing study-level budgets and expenses, such as CRO fees, monitoring travel, shipping costs, etc. These insights let you know proactively when the study will need additional budget. Also, in ASCEND, you can view and query protocol deviations, adverse events, and action items by site or across sites to spot trends.
Additionally, still in that same screen, you can view expected subject visit dates and design a risk-based monitoring (RBM) plan based on forecasted milestones.
Are you getting the picture? It’s a really powerful screen.
One other feature to note: on the Home screen, ASCEND posts notifications of site visit reports that need your review or approval, and you can access each report directly through its notification. Perficient’s ASCEND supports 21 CFR Part 11-compliant electronic signatures, making site visit reports 100% electronic.
With all of that functionality at your fingertips, Siebel CTMS can make your complicated, stressful job much, much easier. You might even have a minute to celebrate your successes!
To learn more about Siebel CTMS or Perficient’s ASCEND CTMS, contact us. To make life even easier, integrate Siebel CTMS with your EDC system.
