Posts Tagged ‘PI’

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, […]

CX Methodology And Site Relationships: Duke-FDA Case Study

If you haven’t read the previous posts in this series, be forewarned that this week’s post might be a little hard to follow, as it assumes you have all of the context from the series to-date. Still, I encourage you to dive in, and I’ll do my best to connect all of the dots for […]

CX Insights And Journey Maps Improve Clinical Site Relationships

In the previous posts in this series, I’ve explained why you should consider clinical sites as your “customers,” and what customer experience (CX) methodology is and how it’s used. In this post, I’ll explain how the methodology applies to clinical sites and how the insights it provides can help improve site relationships. With the notion […]

Why You Need To Think Of Clinical Sites As Your Customers

Earlier this year, Duke University and the United States Food and Drug Administration (FDA) published a jointly conducted study focused on principal investigator (PI) retention. After surveying 201 PIs, they confirmed the industry’s suspicion that PI turnover is a serious issue: 54.2% of respondents reported that they completed a single clinical trial and then stopped. […]

One Of The Best Ways To Improve Relationships With Clinical Sites

Clinical trials are the biggest expense in the drug development process, and there are myriad systems out there designed to reduce operational costs. In fact, Perficient implements, integrates, and hosts several of them. But, what we are seeing now in the life sciences industry is a growing awareness of front-line operations; that is, an interest […]

Duke & FDA Study On Investigator Retention Shows 54% Turnover

Last month, Duke University and the FDA released the results of a jointly conducted study on principal investigator (PI) retention. The study was released early online, but the print version is being published in June in the journal of Contemporary Clinical Trials Communications, published by Elsevier. The purpose of the study was two-fold: 1) to […]

Don’t Let Your Investigators Ruin Your Study By Doing This

Don’t Let Your Investigators Ruin Your Study By Doing This

I enjoy reading FDA Warning Letters. They’re insightful and often entertaining. Sometimes, though, they’re kind of unbelievable. And, sometimes, they’re downright nauseating. Take, for example, this letter issued on February 19, 2016 to a principal investigator (PI) based in New York. FDA inspectors found him to be in violation of 21 CFR Part 312.62(b), related […]