How many comprehensive IT solutions, and more specifically those that relate to the clinical trials space, have the ability to be implemented on-premises or hosted in the cloud, in just a matter of weeks? Not many. When it comes to clinical trial management systems (CTMS), there are even fewer. ASCEND, an Oracle Siebel CTMS accelerator, […]
Posts Tagged ‘21 CFR Part 11’
Collecting and Reporting Adverse Events in Excel
Jody Trader, a pharmacovigilance and drug safety specialist at MMS Holdings, a CRO based in Michigan, recently published a blog post on whether or not Microsoft Excel was sufficient for capturing and reporting adverse events. Since validated safety databases, such as Oracle’s Argus Safety, are often costly, sponsors and CROs continue to use spreadsheets for […]