Life Sciences

Digitally signing documents is easier than you might think. It’s also much faster than having to print, sign, and scan them. And, of course, there’s a significant cost-savings for companies that frequently mail and store hardcopy documents. A product like CoSign can be a great solution for companies, especially those in highly-regulated industries that require […]

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, […]

What do our pharmaceutical product advertisements indicate about our national ideals, given the myriad of advertisements seen on the Internet, TV, in magazines, or heard on the radio here in the United States? Interestingly, the United States and New Zealand are the only developed nations that allow direct -to-consumer (DTC) advertising (Liang & Mackey, 2011). […]

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 […]

To drive a car, you need to have a driver. Well, unless you’re Google. Or Tesla, for that matter. The same goes for clinical trials: you can’t conduct clinical trials without investigators. While the comparison may be a stretch, it’s fairly easy to understand the key role investigators play in clinical trials. So, why are […]

On November 13, 2014, I’ll be delivering Taking Ownership of Custom Database Roles in Oracle Clinical and RDC, a one-hour webinar that’ll cover the following topics: Reasons to create custom roles Process of creating a custom role Granting the necessary access and privileges to a new role Granting the new role to the appropriate user […]

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 […]

When launching a product into the consumer marketplace, you want to have a solid strategy to achieve the greatest success possible. It’s no different when pushing a new drug or device to market, regardless of how big your market is. One of the most important pillars in your strategy should be patient support. For those […]

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 […]