Life Sciences

  When evaluating Oracle Argus Safety for the reporting and management of adverse events or product complaints, one thing is clear to me; a company can save a tremendous amount of time by leveraging Argus’ innate functionality to assist in the tedious tasks around case entry. In the next few blog posts, we will look at several […]

  If you have children, you know what it like is to give them a shot or any other type of medication. You also know what’s it’s like to take them to the doctor and have a “stranger” give them a simple checkup, let alone convince them to comply with more intrusive requests. That’s why […]

  Sponsors are known to work with multiple contract research organizations (CROs). And, depending on the agreement in place with each CRO, data can be captured in either the sponsor’s systems (CDMS and/or EDC) or the CRO’s. If the data is stored in CRO databases, there may come a time when it needs to be […]

  A couple of weeks ago, I wrote about a warning letter that was issued to a pharmaceutical company last month. I highlighted one of the FDA’s findings, which had to do with the company’s standard operating procedures (SOPs) having an insufficient amount of detail about their process for collecting adverse events. Today, I want […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Regarding user accounts: During the User Acceptance Testing (UAT) of a system, are these accounts regulated the same way or can ‘generic’ […]

  What do you do when the largest contract research organization (CRO) in the world agrees to appear in a video promoting several products? You watch, of course! Quintiles recently recorded a video that features the company’s president of clinical development discussing their use of Oracle Health Sciences solutions, such as Siebel Clinical Trial Management […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: The Scope section requires access to electronic records and signatures (ER/ES) at all times. What if the electronic system used by a […]

  If you really think about it, it’s quite astonishing that Viagra sales in 2014 grew 47% in China, a country in which discussing sexual health-related topics has long been considered taboo. So, what caused this surge in sales?

  Last week we covered dashboards in Oracle’s Argus Safety. Today we’ll talk about Worklists. Worklists in the drug safety and pharmacovigilance system can be seen as the end-users task list for the day. While there are many Worklists to help organize a company’s users, today we will focus on two of the main ones, which […]

  Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: 

  Now that June is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in May – they’re ranked in order of popularity, with number one being the most viewed piece. 

  We recently discussed customizing and configuring clinical trial software that is hosted in the cloud. For the final post in our “cloud fact or fiction” blog series, we’ll discuss the hot topic of validation.