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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.

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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 […]

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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 […]

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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, […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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 […]

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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, […]

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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 […]

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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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How To Fix Cumbersome Site Monitoring Visits To Clinical Sites

While sponsors, contract research organizations (CROs), and clinical sites all acknowledge that site monitoring is a necessary part of ensuring clinical trials are run in compliance with governing regulations and protocols, it can be a rather burdensome process, both for monitors and for sites. Monitors struggle with scheduling the visits, having access to everything they […]

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How To Fix Poor Clinical Document Compliance At Clinical Sites

Keeping sites in compliance with their required documents is an ongoing battle for every sponsor and contract research organization (CRO). Considering the volume of documentation involved in a clinical trial, it’s no wonder why sites struggle to stay on top of it, or why sponsors and CROs get frustrated when auditors issue findings against them […]

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How To Fix Clinical Data Entry Mistakes At Clinical Sites

Dirty clinical data is one of the most costly aspects of clinical trials. Not only does the review and cleanup slow down time to market and increase development costs, dirty data can stall or even kill a new drug application (NDA). Consistently receiving dirty data from sites can seriously damage a sponsor’s or contract research […]

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How To Fix Ineffective Subject Screening At Clinical Sites

Even when sites are able to recruit a large pool of potential subjects, sponsors and contract research organizations (CROs) see far too many subjects who fail to pass the screening visit (screen failures) and subjects who pass the screening visit only to leave the study early (early terminations). Because sites get paid for every subject […]

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How To Fix Slow Subject Recruitment At Clinical Sites

Even the most promising clinical sites can have trouble recruiting enough eligible subjects. Pressure from upper management and/or the sponsor organization to meet recruitment targets causes stress and anxiety for study managers, which in turns strains their relationships with underperforming sites. This tension can be alleviated by helping sites: Broaden their pool of potential subjects […]

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7 Ways To Fix Your Relationships With Clinical Sites

In our nearly 20 years of working with the life sciences industry, we’ve spoken with countless pharmaceutical, medical device, and contract research organizations (CROs) about their relationships with clinical sites and investigators. We’ve listened to their struggles and the things they’ve done to try to make things better, including what’s worked and what hasn’t. We’ve […]

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6 Key Takeaways About Customer Experience (CX) In Life Sciences

The previous 12 posts in this series have taken us on quite a journey. We started by defining the term “customer” in the context of pharma and med device, discussed why “customer” and “customer experience” (CX) matter in life sciences, and rounded it out by walking through each of the seven dimensions of CX maturity […]

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Customer Experience (CX) Dimension #7: Culture

The seventh (and final!) of the seven customer experience (CX) dimensions discussed in Perficient Digital’s CX guide is Culture. Even though it comes at the end, numerically, if you look at the diagram, it leads right back into strategy and the rest of the dimensions. That’s because it’s culture that actually keeps the CX wheel […]

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