Posts Tagged ‘Oracle’

Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do […]

In our last “cloud fact or fiction” post, we discussed the cost of implementing clinical trial software in the cloud. This time around we’ll address the ongoing costs you can expect to see if you decide that hosting your applications in the cloud is the way to go. Claim #3: Ongoing costs for cloud/hosted clinical […]

The other day, I was watching Cory Johnson interview Bryson Koehler, CTO and CIO of The Weather Company, on Bloomberg West. While the talk focused on The Weather Company’s business model, I thought several points during the discussion were quite relevant to life sciences companies. Frankly, they’re applicable to most industries. The Weather Channel, which […]

We’re all users of software. Put us in front of two systems – one that looks outdated and unorganized, and one that looks good and structurally makes sense – and I bet you’d gravitate to the latter one. In fact, although I didn’t conduct a poll, I’m sure we’d all choose the latter. It’s not […]

I recently heard a segment on the radio about personalized medicine. Or “translational medicine.” Or “translational research.” Or “precision medicine.” Whatever you want to call it! Dr. Murray Feingold, a pediatrician and geneticist in the Boston area, painted a clear description of the term. He put it in words that all of us can understand. […]

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, […]

Oracle recently announced a new version of Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS). Some of the enhancements in version 5.1 include: Support for Partial Source Data Verification (SDV): Oracle Clinical and RDC Onsite now support creating a risk-based SDV plan that identifies only a subset of data requiring verification in […]

Anyone evaluating clinical trial, clinical data, and safety management systems today will also need to decide whether to implement on-site or in the cloud. As each year passes, more and more companies are choosing the cloud for a whole host (pun intended!) of reasons. Over the next few weeks, my colleagues and I will examine […]

Deciding “if, when or how” to move from one safety application to another can be a daunting task full of angst, pressure and fear of the unknown. Arguably, most of this distress is experienced in the initial analysis of the migration options and sifting through the solutions available to an organization. This blog entry will attempt […]

It’s not uncommon for clinical project managers to generate a regular status report for each of their ongoing studies. What’s more common, unfortunately, is the cumbersome way they go about it: collecting clinical trial data from study managers, entering it into an Excel spreadsheet, and running countless calculations – the process can be highly labor-intensive. […]

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 […]

As 2014 comes to a close, a few last-minute accolades are being awarded. I recently wrote about BioPharm, a life sciences-focused IT consulting company that Perficient acquired in April 2014, being named to Inc. Magazine’s 5,000 fastest-growing private companies in the United States for 2014. Just yesterday, we received word that BioPharm was named to […]