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Life Sciences

How To Improve Clinical Site Compliance With Essential Documents

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 […]

What Happens During NDA Review In The FDA Drug Approval Process

This post is the fourth in a brief series about the FDA drug approval process. The series is designed to answer the question about why U.S. prescription drugs are so expensive by illuminating the FDA drug approval process, stage by stage. In my last post in this series, I focused on the clinical stage, and […]

What Pharmacovigilance Means And Why It Matters

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 […]

How To Mitigate Risk When Changing A Regulated System

A few weeks back, I described how to determine the risk level of a proposed change to a regulated IT system. I also talked about how the system risk level (SRL) and change risk level (CRL) work together to determine the level of rigor required to implement a proposed change without disrupting its validated state. […]

Life Sciences Is Not Immune To The Age Of The Customer

This is the second post in a series about applying customer experience (CX) principles to life sciences. In the first post, I discussed a critical underpinning concept for the blog series related to how “customers” are defined in life sciences. Here’s a quick recap: Since patients don’t typically buy their medications or medical devices directly […]

How To Make Clinical Subject Recruitment Easier On Clinical Sites

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 […]

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 […]

Applying The Concept Of Customer Experience (CX) To Life Sciences

My colleagues in Perficient Digital, Perficient’s in-house digital agency, recently published a fantastic guide about customer experience (CX). While the guide focuses primarily on retail customers, a lot of the advice it contains can be quite helpful for life sciences, so I thought I’d take a stab at translating it for you. Now, in full […]

Practical Ways To Keep Investigators Happy, Productive, And Loyal

This Thursday, July 13 @ 9 a.m. central time, my colleague (and one of my favorite people on the planet!), Param Singh, is delivering a 30-minute webinar on a really hot topic: clinical investigator retention. Trust me – this topic is worth 30 minutes of your time! What’s especially neat about this particular webinar is […]

Role Of Clinical Trials In The FDA Drug Approval Process

Last time, I published the second in a brief series of blog posts designed to provide insight into why prescription drugs in the U.S. cost as much as they do. The series is focused on explaining the FDA drug approval process in layman’s terms. My previous post focused on the first stage in the process, […]

Lessons From Mark Zuckerberg’s Alaska Trip & Early Facebook Days

Mark Zuckerberg, Facebook’s CEO, recently took a trip to Alaska as part of his personal challenge to have visited every state in the U.S. by the end of 2017. In a post, he shared his thoughts on Alaska’s Permanent Fund Dividend, which provides residents with a portion of the oil revenue the state makes. Each […]

Release Notes: Oracle/Perficient’s Clinical Apps [July 2017]

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 […]

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