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 Clinical Administrator, what you might not know is exactly how it would make YOUR work life easier. Intrigued? Then, read on.
In any CTMS, the Clinical Administrator is the behind-the-scenes workhorse who makes everything work seamlessly for the rest of the users. The Clinical Administrator is the person who maintains the Investigator Database and who sets up all of the studies and sites at the start of a trial.
In Siebel CTMS, data entry is centralized, meaning that any given record only needs to be entered once, after which it can be associated with other records an infinite number of times.
For example, let’s say Dr. Michael Adler works at his private practice Mondays, Wednesdays, and Fridays, volunteers at a low-income clinic on Tuesdays, and consults at Children’s Hospital on Saturdays. Let’s also say that he happens to be the Principal Investigator (PI) for one of your studies, and a subject matter expert for another study.
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In another CTMS or application you’re using to manage your trials, Dr. Adler’s busy schedule could mean that he would need to be entered five separate times. But, in Siebel CTMS, his name would only be entered once, and his name would then be associated with each business where he works (once), each address where he works (once), and each study (once).
Now, what if you realized Dr. Michael Adler’s name was spelled wrong? What if his last name was actually Alder, not Adler? In another application, you would need to find each instance of his name and correct it. In Siebel CTMS, you would correct it (once) in the same place where you entered it the first time, and the correction would magically appear in each instance.
Just take a moment to think about how much cleaner your Investigator Database and study data would be with this kind of centralized data entry and maintenance…
This concept applies to lots of other types of records too: investigational products, overarching clinical programs, and individual studies are each entered just once and then associated with other relevant records. And, Perficient’s Siebel CTMS accelerator, ASCEND, has streamlined the administration of the system, all of these records are administered in a single screen.
Now, sticking with the theme of centralized data entry, here’s the best part: templates. You know the subject visit schedule outlined in the protocol, and how each subject in a trial needs to adhere to follow that schedule? In Siebel CTMS, you create that visit schedule (once) as a template, and then the Study Manager or Clinical Research Associate (CRA) applies that template to each subject as he/she enrolls.
The same goes for the study start-up checklist, study close-out checklist, essential documents list, and even trip report questionnaires – the Clinical Administrator sets up each of these (once) as a template, and then the other users apply them and fill them out as appropriate.
Can you imagine? Simple, streamlined, consistent, clean. When you stop and think about it, for a Clinical Administrator, “once” might just be the most beautiful word in the English language.