Category: Uncategorized
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Unleashing the Power of Decentralization in Trial Master File Talent Acquisition
Greetings, Forward-thinking TMF Professionals! Welcome to the latest edition of Granular Level, your trusted source for all things related to the world of Trial Master File (TMF). In this issue, we explore the correlation between decentralized clinical trials and how employers should embrace decentralization when hiring TMF candidates. The Rise of Decentralized Clinical Trials Decentralized…
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Why Internal TMF Mock Inspections are Essential for Clinical Trial Success
Today, I want to talk about something that’s crucial for anyone working in the clinical research industry – the importance of conducting internal Trial Master File (TMF) mock inspections. For those of you who may not be familiar with the term, the TMF is a collection of essential documents that provides a complete history of…
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Inside a TMF Mind
By Nicole M. Palmer and John R. Nocero Motivation and personal development help people achieve their goals and become successful. Learning how to cultivate a positive and organized mindset when it comes to maintaining a Trial Master File is essential to ensure you are giving your best. The TMF is a very valuable piece for…
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I Love the TMF: Your Guide to Staying Organized
Written by Nicole M. Palmer As a professional in the clinical research industry, you understand the importance of maintaining a well-organized TMF. It is the backbone of any clinical trial and contains all the documentation necessary to support the study’s conduct, from start to finish. But, with all the documents, processes, and stakeholders involved, staying…
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Are You a Laggard in Clinical Research?
Written by Nicole M. Palmer and Edye Edens In a world of innovative and life-saving therapies, where we constantly push scientific and biomedical boundaries, how is our industry still full of late adopters? As a research compliance expert, this is one of the most frustrating elements of the clinical trial industry. We surround ourselves in…
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File Naming Conventions Matter
Written by Nicole M. Palmer and John R. Nocero Before you get started, it’s important to establish how you are going to name your files. This will ensure that your file names will remain consistent and that everyone will know what the process will look like and how it will work. Whether your TMF is…
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Follow These 3 TMF Tips for Career Progression
Written by Nicole M. Palmer It’s that time of year when you start thinking about the New Year and New Goals! You are tired of staying stagnant. We are creatures by habit to stay in motion. We are meant to move. We can only stay in one spot for so long until we get restless.…
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Trick or Treat Trial Master File
Trick or Treat TMF Written by Nicole M. Palmer and John R. Nocero Trick or Treat? What are you going to be for Halloween? Today my team and I dressed as the Backstreet Boys as we presented a collaborative approach to compliance. It was something that we decided as a group to do – all…
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TMF Gold
Written by Nicole M. Palmer and John R. Nocero If you’ve been keeping up with the weather in Florida, hurricane Ian was a category 5, which brought high winds and heavy rainfall that resulted in flooding and power outages. Several homes and businesses have been destroyed. When it comes to hurricanes, there’s a lot of…
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Burnout in Clinical Research Is Real
Written by Nicole M. Palmer and John R. Nocero Working in clinical research you can get burnout fast if you don’t set healthy boundaries. There are tight timelines and pressure from upward management to meet trial requirements. There’s always a sense of urgency. It’s important to set boundaries very early on. Set expectations and stick…
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Staying Audit Ready means BEING PREPARED
Written by Nicole M. Palmer and John R. Nocero Inspections are the apex of the clinical trial. It is something that study teams prepare for, plan for and ultimately get nervous about when they are going on. If you haven’t ever been through an inspection before, here’s what you should expect, according to the FDA. Usually, the…
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Peace, Love & Site Signature Sheet
Written by Nicole M. Pamer & John R. Nocero Last week, Nikki and I talked about Peace and what that brings to our lives. This week, we look at defining how to obtain a peaceful and up-to-date site signature sheet. It is easy to get into a war with the site signature sheet…rather, the people…
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TMF Inspection Readiness: There are no Shortcuts
Written by Nicole M. Palmer and John R. Nocero Some people love making a meal in the crockpot because when you cook low and slow the result is worth the wait. Then some people like to zap something quick in the microwave and have instant results. However, the results between the two do not taste…
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You Paid Them How Much?
Written by Nicole M. Palmer, Edye T. Edens and John R. Nocero You just received a vendor invoice and were asked by upper ward management to file it in the Trial Master File. The study is still new, and a Trial Master File plan has not been created. The sponsor has requested that you use…
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Sites Up and Running Lightning Speed
Written by Nicole M. Palmer and John R. Nocero “Lightning is a discharge of static electricity that has accumulated as a result of collisions between ice particles in storm clouds. The return stroke of a lightning bolt travels at approximately 100,000 kilometers per second, which is one-third the speed of light.” The pharmaceutical industry is booming!…
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