Striving for Improved Investigator and Site Relationships

Last year I was invited to present at a conference in San Francisco; it was a wonderful experience. Here are this year’s conference details. 5th annual Outsourcing in Clinical Trials West Coast I was just organizing some files on my computer and came across the slidedeck, “Striving for improved Investigator and site relationships to achieve…

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Improved Investigator and Site Relationships – Part II

This is a presentation I gave at the 4th annual Outsourcing in Clinical Trials conference in San Francisco in February of 2012. It has been posted in three parts: Click here to go back and review Part I  Read Part II below Part III – conclusion _________________________________________________________________ Support the sites in order to maximize subject enrollment…

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Investigator and Site Relationships – Part III

This is the third and final portion of a presentation I delivered at a conference in February 2012 entitled: “Striving for improved Investigator and site relationships to achieve higher commitment and optimal patient numbers” Click here to go back and review Part I  Click here for a link back to Part II Read Part III…

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Happy Thanksgiving

happy thanksgiving to the Lead CRA blog readers

Today I am thankful for time with my family and my little dogs.  I am also extremely thankful for another rewarding and challenging year at work. I love my job and the team I work with make every day in the office interesting and fun.  Their reliability and focus on quality are unparalleled in any of my previous positions and I…

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Site Startup Series

Welcome to The Lead CRA Blog Site Startup Series.  This course of blog posts is designed to step you through the various activities of launching a clinical trial site. What are the regulatory requirements before recruitment can begin? What are typical sponsor requirements? How do clinical trial sites even get chosen? These topics and more,…

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Thinking About Site Startup

Clinical Study Site Startup. Ready to Enroll.

I’ve been thinking a lot lately about how important it is to choose the right clinical trial sites for the success of your trial.  Just last week I blogged about the painful process and high costs of closing non-performing or under-performing sites.  I recently told a non-industry friend that it can take upwards of 18 months sometimes to usher a clinical site…

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Closing Non-Performing Sites

setting poor sites out to pasture

According to a 2009 study by Morrison and Pfizer, roughly 30% of sites that are opened fail to enroll.  Despite careful site selection criteria and thorough feasibility, dud sites are opened in most trials (although unintentionally and we do go to great measures to avoid this). In my career I have only worked on three studies…

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Tips for Better Monitoring Visits

These are four tips for great monitoring visits.  It all comes back to developing solid relationships as a site manager so you will have access, cooperation, and enjoy more productivity during your time on site. 1. Effective Communication Between Visits Maybe your coordinators truly are time-strapped or maybe they just need a little cheerleading.  Great…

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Obtaining Consent More Efficiently

Obtaining Consent for a Clinical Trial Anonymous asks about obtaining consent…  Feb 19, 2012 12:55 PM Hi Nadia, I am very grateful for such an amazing site. I am regularly reviewing your site to know more about CRA responsibilities. I have one question regarding the patient consent form, as per GCP can the patient sign the…

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Lead CRA Q&A: Do We Have To Do an SIV?

Melissa commented in… “Pre-Study Visits and Site Initiation Visits“: Do sites HAVE to have an SIV? Especially for a simple data collection study? Or is a web training sufficient for sites that have done research with us before?  –September 9, 2011 The Lead CRA responds… Hi Melissa, it sounds like you may be working on a non-interventional…

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