MMS Blog

  • CDISC SDTM Programming: Utility Programs and Scope of Code Reusability

    Posted on 6/28/2012 12:33 PM

    The Idea Writing SAS programs for SDTM conversion could be a cumbersome process when the raw data are not CDASH compliant or is a legacy data that did not follow any particular standard for data capture (in CRF and during Data Entry into a designed DBMS screen). This task could be simplified to a great extent if clinical programmers have utility macros (substitution of programming lines) handy with them. Let us see how and why utility macros may be used. Utility macros Fine Tunes Programming T

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  • Pharmacovigilance Trends: Getting to Know the DSUR

    Posted on 6/21/2012 12:40 PM

    In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis. Although both the Food & Drug Administration (FDA) and EU Clinical Trial Directive required what is termed as IND AR and ASR, respectively, the conte

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  • Book Review: The Immortal Life of Henrietta Lacks by Rebecca Skloot

    Posted on 6/7/2012 9:04 AM

    Henrietta Lacks is the human source of the cell line that is today known as “HeLa.” This cell line has been used to develop numerous technologies and advances in cell biology and medicine. The source of the cells is often misidentified as “Helen Lane.” Rebecca Skloot’s book The Immortal Life of Henrietta Lacks gives an excellent overview of the life and family of Henrietta Lacks with the scientific concepts explained in layman’s terms. The socioeconomic and racial issues of the Lacks’ family his

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  • Circadian Rhythm and Sudden Cardiac Death

    Posted on 5/31/2012 9:08 AM

    Circadian rhythms (9) are physical, mental and behavioral changes that follow a roughly 24 hour cycle, responding primarily to light and darkness in an organism’s environment. They are found in most living things, including animals, plants and many tiny microbes. Circadian rhythms are produced by natural factors within the body, but they are also affected by signals from the environment. Light is the main cue (9) influencing circadian rhythms, turning on or turning off genes that control an orga

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  • Effective Medical Writing: Insights on Pharma & Biotech Deliverables

    Posted on 5/24/2012 9:15 AM

    Medical writers at Contract Research Organizations (CROs) are playing an increasingly prominent role in writing documents associated with bringing drugs to market - everything from pharmacology reports that summarize testing results for potential new drugs, to safety summaries in New Drug Applications (NDAs) submitted for approval by regulatory bodies. A day in the life of a medical writer consists of producing high quality documents in usually the shortest amount of time possible. Clients, that

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  • 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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