Posts Tagged ‘Safety’

Is the Clinical Development Platform Approach Right for You?

Life sciences organizations typically manage their IT infrastructure and applications in silos. They implement disparate applications and manage the content and process within those applications separately. They then deploy integrations between those applications to streamline processes and share content and data with different business areas. Much of this work, including the development of integration tools […]

Regulatory Updates for Safety: Oracle Health Sciences Connect 2021 Session Recap

During a session at this year’s Oracle Health Sciences Connect conference, Oracle presented recent and upcoming regulatory updates from regulatory agencies around the world for safety. Due to the pandemic and new COVID vaccines, the regulatory update that piqued my interest most was related to the Postmarketing Safety Reporting (PMSR) requirements for Combination Products. The […]

data privacy day perficient

Six Ways to Protect Yourself and Your Family on Data Privacy Day

This article was co-written by Iman Watson, senior solutions architect, and Kailey Hughes, lead development representative. As we mostly are working remotely these days, securing your space when you’re not in the safeguards of the office walls are critical. Perficient places a high value on data security and has several processes and tools in place […]

Oracle Argus Safety On-Premises Is Not Going Away

Many questions and concerns have been floating around the Oracle Health Sciences customer community about Argus Safety’s future on-premises releases. That’s great news for customers who are running the system in-house and might want to upgrade. As a partner with deep expertise in Argus, as well as PV/safety services that include application support, cloud hosting, […]

Building Better Safety Profiles With Real-World Data & Evidence

The use of real-world data has exploded in recent years and will continue playing a crucial role in 2018. Almost every major pharmaceutical and medical device company conducts real-world studies to build better safety profiles for their products, as well as support initial study findings. Real-world data can come from a variety of sources including […]

Top 5 Pharma & Medical Device Blog Posts From October 2017

Now that November 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 October – they’re ranked in order of popularity, with number one being the most viewed piece. Aggregate Report Preparation In Safety […]

The Driving Force Behind Autonomous and Connected Vehicles

The benefits of driverless cars are limitless. According to the United Nations, each year 1.25 million people die in auto accidents globally (40,200 in the U.S. alone), and as many as 50 million are injured. More than 90% of accidents are due to human error or distraction. Forty percent of fatalities are related to drunk […]

Aggregate Report Preparation In Safety And Pharmacovigilance

Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose. What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter […]

What The FDA Requires Of Drugs On The Market

This is the final post in a brief series of posts (five in total) designed to demystify the high cost of prescription drugs in the U.S. Today’s post focuses on the fourth and final stage the of the FDA drug approval process: post-marketing. Before we dive into the final stage, here’s a quick recap of […]

All You Need To Know About Oracle Argus Safety 8.1 In 30 Minutes

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 […]

Learning Opportunity: Webinar on Maximo HSE Manager; July 14

As part of the Maximo Friday webinars, one of the next sessions will discuss the Industry add-on called Health, Safety & Environmental Manager (HSE). It’s not just for Oil & Gas clients, others can use it too.  This add-on can help you identify and manage operational risk within your organizational work. Previous versions of IBM […]

EudraVigilance: Some Things To Consider Right Now

E2B(R3) So, there we have it, the European Medicines Agency (EMA) has finally issued a statement, which confirms the date of release for the bigger, better EudraVigilance: November 22, 2017. Time to go into panic mode? Absolutely not. But, here are some of the things you should be thinking about as the deadline approaches: Training […]

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