Marin Richeson

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 […]

In June 2017, the United States Food and Drug Administration (FDA) issued a new draft guidance document for public comment: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.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 […]

In today’s post, which is part of a series aimed at applying my colleagues’ customer experience (CX) strategy guide to a life sciences audience, we’re getting up-close and personal with retail. Perficient Digital’s CX strategy guide includes a number of statistics from myriad sources (see guide for sources) about the buying process in the Age […]

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 […]

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 […]

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. […]

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 […]

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 […]

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 […]

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 […]

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, […]

This is post #4 in a short series about assessing and mitigating risk with regulated software. Over the past few weeks, I’ve discussed the rationale for taking a risk-based approach to this topic, as well as the first couple of steps to take: determining whether a system is regulated and, if so, determining its risk […]