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  • I Love the TMF: Your Guide to Staying Organized

    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…

    nmpalmer1

    March 29, 2023
    Uncategorized
  • Are You a Laggard in Clinical Research?

    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…

    Nicole Palmer

    March 13, 2023
    Uncategorized
  • The Name Game

    The Name Game

    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…

    Nicole Palmer

    January 24, 2023
    Uncategorized
  • Follow These 3 TMF Tips for Career Progression

    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.…

    Nicole Palmer

    December 22, 2022
    Uncategorized
  • Trick or Treat Trial Master File

    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…

    Nicole Palmer

    October 30, 2022
    Uncategorized
  • TMF Gold

    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…

    Nicole Palmer

    October 4, 2022
    Uncategorized
  • Burnout in Clinical Research Is Real

    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…

    Nicole Palmer

    September 9, 2022
    Uncategorized
  • Staying Audit Ready means BEING PREPARED

    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…

    Nicole Palmer

    August 25, 2022
    Uncategorized
  • Peace, Love & Site Signature Sheet

    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…

    Nicole Palmer

    August 11, 2022
    Uncategorized
  • Crockpot or Microwave?

    Crockpot or Microwave?

    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…

    Nicole Palmer

    July 26, 2022
    Uncategorized
  • You Paid Them How Much?

    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…

    Nicole Palmer

    July 14, 2022
    Uncategorized
  • Sites Up and Running Lightning Speed

    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!…

    Nicole Palmer

    July 5, 2022
    Uncategorized
  • 10 Ways to Break into The Trial Master File Industry with No Experience

    10 Ways to Break into The Trial Master File Industry with No Experience

    Written by Nicole M. Palmer and Dante Alducin 6 months ago, I did a poll on LinkedIn, and I asked, “How did you break into the TMF industry.” Do you know that more than half responded with NO EXPERIENCE! I am living proof that if I can do it so can you. I will always advocate…

    Nicole Palmer

    June 23, 2022
    Uncategorized
  • Get Your TMF Data Back in Shape with Integrity

    Get Your TMF Data Back in Shape with Integrity

    Written by Nicole M. Palmer and John R. Nocero Have you ever looked at dirty Trial Master File (TMF) data? I would be lying if I said, ‘No.’ That’s because I am a person with integrity. I like to follow the rules and your TMF should too. Let’s look at ICH GCP E6 R2 and…

    Nicole Palmer

    June 21, 2022
    Uncategorized
  • TMF Secrets to Pass an Audit

    TMF Secrets to Pass an Audit

    Written by Nicole M. Palmer and John R. Nocero You just received written notice that the Trial Master File (TMF) that you are assigned is being audited by your internal QA department. Now what? Are you cool as a cucumber or sweating like you just ran a marathon? Being inspection ready is a lot like…

    Nicole Palmer

    June 9, 2022
    Uncategorized
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