You probably know 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 leading CTMS out there. But, as a Clinical Document Associate, what you might NOT know is exactly how it could be YOUR ticket to freedom. Interested?
To understand the value of Siebel CTMS for Clinical Document Associate, there’s really just one word you need to know: templates.
Let’s face it – there are a LOT of redundancies in a clinical study, and even across studies. You need the same set of documents from each Principal Investigator at each site. You need to supply each site with the same set of documents. For all sites within a specific country, you need to send and collect the same set of extra documents.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
When so many sets of documents are the same, why should you have to type in the titles over and over for each site in each country? You shouldn’t.
In Siebel CTMS, the Clinical Administrator sets up a “template” for each set of documents that you use, and then your job is as simple as this: apply the appropriate templates to each site and fill in the relevant fields. There’s even a function that allows you to update multiple records at once. So, when you send the essential documents packet to a site, all of those documents will have the same “Sent Date,” so you can update that field for all of the docs in the packet with a single click. Same goes for “Received Date,” “Signature Date,” and any other field in a document record.
In Perficient’s Siebel CTMS accelerator, ASCEND, we’ve taken this a step further, adding additional fields that are commonly requested, including a URL field in which you can enter a link to the scanned document in your electronic document management system (EDMS).
On top of all of that, Siebel’s native “query” ability allows you to run ad hoc reports to learn, for example, which documents are overdue, which are due within the next 30 days, and which are expiring in the next 60 days – not just by site, but by study, clinical program, country, or all of Clinical Operations.
Siebel’s template functionality minimizes data entry and typing errors, and ensures consistency and compliance across sites and studies. Siebel’s mass-update functionality saves a boatload of redundant data entry time. And, Siebel’s query functionality allows Clinical Document Associates to know where things stand with their docs at any given time, which is especially helpful when Finance and Regulatory come a-knocking about the status of 1572s, financial disclosures, PI licenses, and so forth. Siebel CTMS help you answer all of their questions in a matter of seconds.