MMS Blog

  • Drug Patent Evergreening: An Overview

    Posted on 7/26/2012 12:24 PM

    First let’s see what patent ever-greening is and how it came into existence? Patent ever-greening refers to a strategy of obtaining multiple patents that covers various aspects of the same product. Even though it is not a formal concept of patent law, patent owners utilize this process to extend their monopoly privileges. Some examples include seeking subsequent patents on derivatives of existing drugs, altering the mixture of isomers, identifying compounds with the same molecular formula but

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  • Part 1: DIA 2012 Annual Meeting, Recap and Highlights

    Posted on 7/19/2012 12:28 PM

    The 2012 Drug Information Association (DIA) Annual Meeting in Philadelphia is in the books, and I am very grateful to have had the opportunity to speak at a lecture session in the Medical Writing and Medical Communications track. The 90-minute session, titled, “Medical Writing Competencies and Best Practices in the Global Environment”, focused on specific, applied ways that medical writers can employ strategies for efficient drafting, review, and management of documents. From developing and ef

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  • 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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