MMS Blog

  • 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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  • Case Study: MMS Support for Final Study Tables

    Posted on 9/29/2011 11:29 AM

    THE CHALLENGE: Budgetary Issues Bring Phase 2b Study to a Halt To secure additional funding for continued business operations, a small pharmaceutical company was required to submit a Phase 2b study. However, during development of the study, the company encountered budgetary issues that forced them to discontinue the project. Making matters worse, their clinical research partner declined to participate in any further business activities without a significant operating budget. To get the study ba

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  • Book Review: Monday Morning Mentoring

    Posted on 9/22/2011 11:32 AM

    Monday Morning Mentoring is book on leadership by David Cottrell. This book tells the story of Jeff, a successful manager, who needs to work himself out of an uncomfortable region called “splat” which is located just over the horizon in management land. Desperate for answers, Jeff seeks advice from Tony, the father of one of his college buddies and a very successful entrepreneur. Tony agrees to help Jeff in a series of Monday morning meetings. The intent is not to solve his problems, but to help

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  • Recipe for Programming Success: SDTM Stew

    Posted on 9/15/2011 11:34 AM

    Ingredients: Raw Data (CDASH® brand if possible), CRFs, Protocol, SDTM Implementation Guide, WebSDM (or Open CDISC Validator if you’re on a tight budget), Client Input and 2 to 4 Programmers/Statisticians (4 to 6 for quicker results!). Directions: Begin with a finely grated selection of CDISC SDTM implementation guidelines (for extra spicy, choose version 3.1.2!) Set up trial domains and sprinkle with a dash of consistency to other studies if integration is desired.  Mix raw data, CRFs, Prot

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