Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

Blogs from this Author

Refresher: Which IT Systems Are Regulated

If your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated. If your company is regulated, then every IT system you use to design, develop, conduct trials, manufacture, package, label, store, distribute, install, or service your products is also […]

Common Challenges In Adopting The Shared Investigator Platform

This is the fourth post in a series on the TransCelerate Shared Investigator Platform (SIP). For more background on TransCelerate and the SIP, see the previous three posts. In today’s post, we’ll be looking at the common challenges pharma companies face as they work to adopt the SIP. If you happen to be a pharmaceutical […]

Maintaining Regulatory-Compliant Cloud Solutions

The benefits of cloud hosting – including Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and Software-as-a-Service (SaaS) – are very clear: less upfront capital, faster implementations, scalability and elasticity, and no need for individual companies to maintain physical space, hardware, and/or technical staff for support. But there are also several risks to consider, including physical and technical security, […]

Healthcare Data

Why Companies Are Excited About The Shared Investigator Platform

This is the third post in a series on the TransCelerate Shared Investigator Platform (SIP). For more background on TransCelerate and SIP, see the previous two posts. In today’s post, we’ll be exploring the benefits of adopting the SIP. First and foremost, the SIP resolves one of the biggest complaints expressed by sites, which is […]

Why The Shared Investigator Platform (SIP) Was Created

This is the second post in a series on the TransCelerate Shared Investigator Platform (SIP). For background information on TransCelerate, see the initial post in the series. Very few doctors serve as clinical investigators (approximately 3%), which means many investigators work with multiple sponsor organizations. Each sponsor organization has its own site-facing IT systems and […]

Upcoming Blog Series On TransCelerate Shared Investigator Platform (SIP)

In an industry that has historically been siloed and secretive, the nonprofit collaboration known as TransCelerate BioPharma, Inc. (TransCelerate) is a clear indicator of change. It was formed in 2012 by a group of innovative thinkers and doers from a handful of leading life sciences organizations, with the mission to “collaborate across the global biopharmaceutical […]

Acceptability Equals Mobility

The Case For Involving Treating Physicians In Subject Recruitment

Clinical Leader recently published an article in which the author and a representative of Pfizer made some really interesting points about the role of treating physicians in clinical subject recruitment. The typical approach to recruitment is to target patients directly. On the surface, this approach may seem patient- or customer-centric, but when you look a […]

6 Investigators Received FDA Warning Letters In 2017

It’s been awhile since I’ve written about FDA warning letters, so I thought I would take a look at the letters issued throughout the year and see if anything egregious (or at least interesting) came up. I was surprised to learn that the FDA issued letters to six separate clinical investigators, and I thought the […]

A Compliant Do-Over For Regulated IT Systems

You know how you implemented that regulated IT system a few years ago, and it was all shiny and new, and then it went through a bunch of change controls and the validation documentation got kind of unwieldy, and now you’re kinda wishing you could start over with a clean slate, but without losing the […]

Shared Investigator Platform (SIP) Strengths And Struggles

At any given time, a principal investigator (PI) can be working on one or more studies for a single sponsor company, or multiple studies for multiple sponsors. Likewise, each sponsor runs its clinical trials its own way, using its preferred technology and processes. And, often times, the technology and/or processes differ from study to study, […]

How To Fix Problems With Clinical Site And Investigator Payments

This is perhaps the biggest complaint we hear from both sponsors/contract research organizations (CROs) and sites/investigators. Sponsors and CROs dedicate countless resources to researching and addressing payment questions and concerns raised by site personnel, and site personnel often feel frustrated, undervalued, and distrustful of sponsors and CROs that do not pay them as promised. When […]

How To Fix Having Outdated Contact Details For Clinical Sites

At first glance, having outdated contact information for sites might seem like a pretty minor issue. But when it results in delays related to required documents, monitoring visits, or clinical supplies, the issue quickly becomes more serious. It might be easy to keep a sponsor or contract research organization (CRO) in the loop when a […]

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