I’m sure you’re aware 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 industry leader. But, as a Site Monitor, do you know exactly how Siebel CTMS could help YOU find your Zen amidst all of the chaos? If not, take a few deep breaths, and then read on.
Site Monitors might have the most honorable job in the drug development process. You protect the subjects in a study AND the integrity of the study itself, all of which protects the public. By ensuring that each site is adhering to the approved protocol – properly screening subjects, collecting informed consent, dosing subjects, recording data, reporting protocol deviations, and reporting adverse events – you let us know that we can trust the outcome of the study.
As you are well aware, your primary deliverable is a site visit report or trip report. From what we hear, many of you still fill these reports out manually in a word processing program, after which you email them to your manager for review, and then you print, sign, scan, and upload them into your electronic document management system (EDMS) or electronic trial master file (eTMF) for storage.
Siebel CTMS includes a trip report module that allows trip reports to be completed and routed for review directly in the system. No more Microsoft Word! Additionally, Siebel CTMS’ “template” functionality allows trip report checklists to be converted into standard templates, which can then be applied and filled out, based on the visit type (initiation, close-out, etc.).
Perficient’s Siebel CTMS accelerator, ASCEND, comes with an even more sophisticated trip report module that includes a snapshot of subject enrollment, based on the site visit completion date, and allows relevant records from the site logs – protocol deviations, action items, CRF records, adverse events – to be included in the report with the click of a button. ASCEND also supports 21 CFR Part 11-compliant electronic signatures, and stores each approved trip report as a snapshot in time to preserve the monitoring history.
What’s more, the most recent version of Siebel CTMS (and ASCEND) works on ANY web browser and ANY device, which means that you no longer need to lug around your laptop during the site visit. Just bring your favorite tablet and fill out your report right there, in real-time.
With Siebel CTMS, the only thing holding you back is the reliability of the site’s wireless Internet!
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.
