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Synchronizing Serious Adverse Events and Electronic Data Capture using E2B

Rich Davies: Oct 30, 2016 5:32:59 PM

Electronic data capture (EDC) has emerged as the predominant way to collect data during clinical trials.  At OmniComm Systems, we’ve seen the application of EDC across all therapeutic areas and phases of clinical trials. EDC has become the norm in terms of the way pharma companies operate and collect data from clinical sites.

Database Lock - Not Lockdown

Dennis Constantinou: Oct 23, 2016 6:45:00 PM

The database lock is frustrating for sponsors and CROs because it often leads to costly delays. The lock should not mean lockdown, though. The data produced via a clinical trial belongs to the study sponsor and team, so why the delays?

How Important is eCRF Standardization?

Dennis Constantinou: Oct 16, 2016 6:10:11 PM

The electronic case report form (eCRF) is a tool to gather all the data from different electronic and paper based systems. It is important because it makes it possible to assemble and organize diverse data in a manner that fulfills the study protocol and allows the data to be reviewed and analyzed. Data from clinical studies must be integrated for FDA submission and it is beneficial if the data is collected in a standardized format from the start. Standard forms mean simplified electronic data capture (EDC) system training for in-house and site staff. They also streamline the flow of data from collection through submission, whether a single or multi-site study. Data exchange between partners and providers is facilitated, and reviewers can then work with the data with less preparation time.