PIs on Pharma’s Payroll

Who is being paid to conduct clinical trials? A review of Investigator Payments and Sunshine Act buzz

[box style=”2″ close_btn=”true”] Money Matters: It is payday again, so this topic falls under the theme of trial fiscal management. Like a steady paycheck, you can look for blog updates on financial topics in this semi-monthly series. [/box] Which Clinical Investigator’s are on Pharma’s Payroll? Yeah, I’ve Heard of the Sunshine Act. What is it again?…

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Decluttering my Desktop

computer desktop cluttered? I recommend Fences desktop organization software

[box style=”1″ close_btn=”true”] When it comes to techie tips, I’m a junkie. Hopefully there is something new for everyone in this weekly series or at least one special “Ah ha, so that is how you do it” when it for Outlook, Excel, Word, Acrobat, etc. Thanks in advance to Google, my colleagues, and the exasperated…

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Pediatric Clinical Trials

an increase in the conduct of pediatric trials

I have not had the opportunity to work on a pediatric trial, however in the past year several people in my network have worked on these trials. I thought it was interesting that more of my old colleagues were working on clinical trials and after a capabilities presentation from ReSearch Pharmaceutical Services last week I…

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Document Readability

[box style=”1″ close_btn=”true”] When it comes to techie tips, I’m a junkie.  Hopefully there is something new for everyone in this weekly series or at least one special “Ah ha, so that is how you do it” when it for Outlook, Excel, Word, Acrobat, etc. Thanks in advance to Google, my colleagues, and the exasperated…

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Financial Disclosure Forms

financial disclosure forms in clinical trials

Financial Disclosure Forms Updated Guidance In February the FDA issued industry guidance for the collection of financial disclosures.  I’ve summarized and called out a few of the sections I found most interesting.  There were certainly some items I hadn’t thought about in a while so the refresher and clarifications were helpful and the appendix of Q&A was…

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Worthwhile Webinars

Worthwhile Webinars: be credentialed, know your audience, have learning objectives

I’m a huge fan of collaboration and sharing best practices (that’s one of the reasons why I write this blog!) so I like to hear other professional’s opinions and perspectives.  In addition to attending industry conferences, I do a lot of self-study, listening to podcasts, reading journals, and participating in webinars.  Most sessions are a…

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Clinical Site Budgets

Negotiating Clinical Trial Site Budgets for the Schedule of Assessments, one-time fees, and pass-throughs

[box style=”2″ close_btn=”true”] Money Matters: Today is payday, so this topic falls under the theme of trial fiscal management. Like a steady paycheck, you can look for blog updates on financial topics in this semi-monthly series. [/box] Debits, and Credits, and Finance, oh my! Clinical Site Budgets Negotiating Clinical Site Budgets For today’s installment, let’s…

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What is a Clinical Operations Toolkit?

Combining ability, character, and training into a toolkit allows clinical research professionals to problem-solve on the fly

Combining ability, character, and training into a toolkit allows clinical research professionals to problem-solve on the fly and provide quality support for challenging and complex studies.  Administrative skills, interpersonal techniques, intellect, personality, and technical skills all improve with depth of experience.  A little humility helps, too.  As with any individual tool or group of gizmos,…

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Monitoring Tools & Notes

monitoring tools to save you time

Monitoring Tools and Notes As a regional monitor, I have primarily worked on studies with a conduct period of only a few months.  For these trials, I can typically monitor an entire subject’s source in just a couple of monitoring visits (IMVs).  However, I do use a few monitoring tools to keep me organized and…

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3 Simple Ways to Improve the Approach

improve the approach in clinical trial services

I was invited to speak on a panel this week at the Outsourcing in Clinical Trials West Coast conference.  This was my second year in attendance and the conference was an excellent investment of my time with lots of great networking and informative sessions.  The topic for my panel was “Examining mistakes some vendors make…

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