Posts Tagged ‘Clinical and Safety’

Imagine with me: Based on predefined clinical data and milestones, a site monitor receives a notification that one of her sites requires a site monitoring visit. She works with the site to schedule the visit, and both she and the site receive automated confirmation emails. The day of the visit, the monitor arrives at the […]

This is the final post in our brief series on drug safety. If you missed any of the previous posts, here are the links: Why Monitoring Adverse Events And Drug Safety Signals Matters What Exactly Is An “Adverse Drug Reaction?” The Role Of Signal Detection In Drug Safety What Pharmacovigilance Means And Why It Matters […]

This Thursday, Perficient is hosting a webinar on Oracle Data Management Workbench (DMW) alongside Oracle, one of our most valued partners. From Perficient, we’ll have Prabha Ranganathan, the director of clinical data warehousing and analytics, and from Oracle, we’ll have Srinivas Karri, the director of product strategy for DMW. Yesterday, I got a sneak peek […]

Imagine with me: Once successfully enrolled in your study, a clinical subject is issued login credentials for a proprietary mobile app he downloads onto his phone. Over the course of his participation in your study, he receives push notifications to remind him to log periodic diary entries. In the app, he follows interactive prompts that […]

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: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

Now that August 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 July – they’re ranked in order of popularity, with number one being the most viewed piece. All You Need To Know […]

In June 2017, the United States Food and Drug Administration (FDA) issued a new draft guidance document for public comment: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. You have until August 21, 2017, to share your thoughts and ideas about its content. The […]

Starting in Siebel IP2013, a little known enhancement was introduced in Oracle’s clinical trial management system (CTMS): the ability to incorporate Siebel SmartScripts directly into trip reports. What are SmartScripts? According to Oracle’s official documentation, “Siebel SmartScript allows business analysts, call center managers, and Siebel developers to create scripts to define the application workflow for interactive customer communications. […]

Imagine with me: A site coordinator logs into your secure portal and sees a visual snapshot – perhaps a pie chart – of her site’s current compliance with your required documents. While the pie is mostly green, she sees a small slice of yellow and a sliver of red. She clicks on the red sliver […]

Pharmacovigilance, or the practice of monitoring the effects of medicines after they have been released for commercial use, was expanded in 2002 by the World Health Organization (WHO) to include signal detection as a way of improving patient care and improving the overall health and safety of the general public. Today, pharmacovigilance activities should also […]

Imagine with me: While surfing the web on his mobile phone, a young man receives an offer to apply to participate in a clinical trial. He thinks, “Why not?”, creates a user ID and password, and then follows a series of interactive prompts to build out his profile. While there are no current trials that […]

Hi everyone, it’s Indy here. For those of you who may not recognize my name, I’ve been helping lead our Argus Safety installations for the past few years. I wanted to drop a quick note to personally invite you to the webinar I’ll be presenting next week. It’ll be relatively short, by design, but it […]