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  • Case Study: MMS Support for Epilepsy Submission

    Posted on 8/12/2014 3:50 PM

    Challenge: Mid-sized Pharma Requests Help Integrating Data for Agency Presentation A mid-sized pharmaceutical company located in the Midwest was planning for a New Drug Application (NDA). Concerns were raised regarding the feasibility of this submission given the large volume of data requiring conversion into an electronic format and integrated for an agency presentation. The epilepsy submission included more than 40 studies worth of data from a wide variety of sources in various formats. Limi

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  • Combination Therapy: The Path Revealed

    Posted on 9/26/2013 10:51 AM

    The recent advance in the understanding of the pathophysiological process behind some of the most common life-threatening diseases, such as cancer and AIDS, has warranted the need to develop new therapeutic approaches using combinations of drugs directed at multiple therapeutic targets. Combination therapy is a method to treat a disease or a disorder through the simultaneous usage of different drugs having synergistic or additive potential to improve therapeutic efficacy. The final guideline

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  • Are Pharmaceutical Companies Mainstreaming Nutraceuticals?

    Posted on 3/7/2013 11:56 AM

    The term nutraceutical is a word that was coined by Stephen DeFelice, MD in the early 1990’s. Dr. DeFelice is the founder and chairman of the Foundation for Innovation in Medicine in Cranford, NJ. Nutraceutical is a combination of the words “nutrition” and “pharmaceutical” and Dr. DeFelice meant it to describe any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease. Today it is a commonly accepted word in the l

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  • Clinical Trial Disclosure: More “FDA” Needed in Past & Present Acts?

    Posted on 11/29/2012 9:54 AM

    Federal mandates calling for transparency of clinical trial information have been in place in the United States since 1997, but a recent move will finally give the current FDA (Food and Drug Administration) law some teeth to enforce compliance. In September, the US Department of Health & Human Services (HHS) transferred authority from HHS control to the FDA to oversee information that is filed to (“clinical trial registry data bank”), and seek out those who fail to file, o

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  • Clinical Disclosure Reporting: Are You Prepared to Meet the Expanding Requirements?

    Posted on 9/7/2012 10:54 AM

    A group of House Democrats led by Congressman Edward Markey (D-Mass.) on Aug. 2 introduced the Trial and Experimental Studies Transparency (TEST) Act of 2012 (H.R. 6272), legislation that "updates and expands the clinical trial registry data bank——with stronger reporting requirements," according to a press release dated that same day (1). This proposed legislation is yet another step to address the increasing demand for greater transparency of clinical trial information. As we

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  • Setting Ground Rules for Medical Writing Document Review

    Posted on 8/8/2012 12:01 PM

    A medical writer often has to be a jack of all trades in order to ensure accurate, on-time completion of clinical documents. Document review provides a critical opportunity for the medical writer to elicit value-added review from team members. The medical writer can lead strategically by clarifying team members’ roles and responsibilities, setting clear expectations for reviewers, and setting “ground rules” for document reviewers at the outset of the project. The below are suggestions for medica

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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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  • 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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