MMS Blog

  • Medical Coding: Reasons for Becoming a Certified MedDRA Coder

    Posted on 4/19/2012 9:20 AM

    MedDRA or the Medical Dictionary for Regulatory Activities is a tool that has remained to be a mainstay in classifying adverse event information associated with the use of biopharmaceuticals and medical devices. Ensuring consistency and accuracy of the assigned terms has allowed the biopharmaceutical industry and regulatory authorities to exchange and analyze safety data. When I learned about the MedDRA coder certification examination I wondered if becoming a certified medical coder makes a dif

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  • Choosing the Right Clinical Research Organization in 5 Steps!

    Posted on 4/5/2012 9:24 AM

    Choosing a Clinical Research Organization (CRO) is a daunting task. The number one concern of any pharmaceutical company is getting the product to market on time, the first time. Questions arise. Do you use multiple CROs that specialize in different areas or one CRO that does everything? Do you choose a small or large CRO? What attributes do you look for? Here are five attributes to help you narrow your search: Flexibility - Your CRO should be flexible. Being flexChoosing the right pathible is

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  • Research to Medical Writing: Transitioning from Bench-Top to Cubicle

    Posted on 3/29/2012 9:30 AM

    Soon after graduation, I, like many other young researchers, found myself trying to choose from an ever-narrowing pool of opportunities in academic research. Low funding rates and an increasing number of investigators meant that during my seven grueling years spent pursuing an advanced degree, I watched while seasoned investigators, merit award winners, and departmental chairs lost funding. In addition to a growing trepidation about ever receiving funding on my own, I was left with this haunting

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  • Case Study: Advisory Committee Briefing Documents

    Posted on 3/15/2012 9:34 AM

    THE CHALLENGE: Compile a Briefing Book for an Aggressive FDA Deadline A biologics pharmaceutical company was in need of a advisory committee briefing book to present to an FDA Advisory Committee. However, the deadline for submitting the book was too close for the company to pull together the necessary information using only their internal resources. To turn the project around quickly and to meet their rapidly approaching deadline, they brought MMS on board to provide additional expertise. MMS

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  • SDTM Datasets: Unlocking CDER's 7 Most Commonly Found Problems

    Posted on 2/16/2012 9:43 AM

    When Study Data Tabulation Models (SDTM) datasets are part of a submission, the Center for Drug Evaluation and Research (CDER) performs a series of checks to ensure data integrity. When reviewing the SDTM datasets, CDER observes issues that are repeated across various studies and submissions. To make certain these common issues are addressed before submitting SDTM datasets, let’s review them and ensure they don’t happen to us. The points raised below are in no particular order. 1. MedDRA Terms:

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  • Clinical BioStatistician/Programmer: A Day in the Life

    Posted on 1/5/2012 9:48 AM

    [Note: In August 2011, one of my former Statistics professors at GVSU asked me if MMS would be interested in having a booth at GVSU Statistics Career Day, and if I would be willing to give a talk. My presentation focused around my job as a statistician/programmer in the pharmaceutical industry and was geared towards undergraduate and graduate students who were interested in learning more about what a career in statistics is like from the perspective of a former student. The presentation is summa

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  • Case Study: Neuropathic Pain Phase 2b Trial

    Posted on 11/22/2011 10:58 AM

    THE CHALLENGE: Project Delays Threaten On-Time Delivery of SAP and Final Study Results A large pharmaceutical company and their development partner were finalizing the Statistical Analysis Plan (SAP) and preparing for final reporting in order to present at an upcoming shareholder’s meeting. With the presentation date quickly approaching, however, their progress was slow due to delays in finalizing the database and questions related to the quality of the SAP. Concerned they would be unable to co

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  • Data Management Best Practices

    Posted on 10/27/2011 11:22 AM

    Electronic Data Capture (EDC) systems should be more than just a means to an end. Quality EDC systems can enable the entire clinical trials information management process. However, if the system enables, it is the data managers who drive. They are burdened with designing processes to make the transition from paper to EDC efficient while maintaining the integrity of the data. And while such efficiency sounds simple in theory, it requires extensive preparation prior to the start of an electronic c

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