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  • Validated Safety Database or Excel Tracker for Clinical Study Serious Adverse Events

    Posted on 7/24/2015 10:06 AM

    Implementing a validated safety database can cost a pharmaceutical or biotechnology company tens of thousands of dollars. It is a significant monetary investment along with a significant investment in resources. For this reason, many smaller companies have continued to stay with “old fashioned” Excel spreadsheets to record and track serious adverse events (SAEs) reported during clinical studies. Noteworthy potential issues with this method are as follows: Excel spreadsheets are not 21 CFR Part

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  • Race & Ethnicity in Clinical Research

    Posted on 3/4/2015 12:40 PM

    Defining the Problem The role of race and ethnicity in biomedical research is constantly under debate. After sequencing the human genome and mapping human genetic variations, there are contradictory beliefs and practices about the use of race and ethnicity in clinical research. These beliefs and practices endorse the concept of a socially constructed race and ethnicity, yet at the same time they are often treated as genetic variables. Is it scientifically correct to treat race and ethnicity as

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  • The Year in Review: The Most Exciting Advances in Neuroscience in 2014

    Posted on 1/13/2015 2:50 PM

    Neuroscience continues to advance rapidly, with tens of thousands of new peer-reviewed articles each year. Several findings stood out to me in 2014 as being relevant for neurology and psychiatry drug discovery and development. This summary scratches the surface… Clinical Neuroscience Studies: Cognitive deficits in schizophrenia are a huge unmet challenge because existing antipsychotic drugs do little to help impaired memory, planning for the future and “emotional IQ.” Santarelli and colleagues

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  • Probiotics – Food for Thought?

    Posted on 9/9/2014 3:31 PM

    In your food, at your doctor’s office, in your body… these microorganisms seem to be supplementing our diets, supplementing our medications, and inhabiting our daily lives. But does anyone really know what they are or who’s monitoring their use? Google advertises brand name probiotics with claims to be gastroenterologist recommended and clinically tested. Further down the page, search results produce definitions of probiotics from sites such as WebMD and Wikipedia declaring the health benefits

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  • The COMPETE Act of 2014 – Extending the R&D Tax Credit

    Posted on 8/26/2014 3:38 PM

    Senator Tom Carper (D-Del) recently introduced the Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2014, otherwise known as the COMPETE Act of 2014, in Congress. This bill seeks to amend the Internal Revenue Code of 1986 to increase and make permanent the alternative simplified research credit. Supported by the Association of Clinical Research Organizations (ACRO) and Biotechnology Industry Organization (BIO), the COMPETE Act of

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  • Expanding the Discussion: Assessing CV Safety in Clinical Research

    Posted on 2/25/2014 4:30 PM

    Clinical drug trials are always challenged with creating clear, standardized definitions of cardiovascular (CV) event outcomes that can be easily agreed-upon and evaluated by regulatory agencies. As data from several different clinical trials are frequently compiled to gain a fuller understanding of the investigational drug, it is important to use definitions that can be recognized across various studies. CV endpoints currently being examined in clinical studies are usually based off of a custom

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  • Modern Approaches to Assessing CV Safety in Clinical Drug Research

    Posted on 1/28/2014 4:32 PM

    Cardiovascular (CV) events have always been a prime focus in clinical drug research, but have been of increased concern to the FDA in recent years. In 2007, a well-publicized meta-analysis by Nissen and Wolski identified an increased risk of myocardial infarction and death due to CV causes associated with the anti-diabetic drug rosiglitazone1. The FDA Endocrinologic and Metabolic Drugs Advisory Committee met in July 2008 and determined that concerns about CV risks during premarketing and postmar

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  • An Insight into the Processing of CDISC Compliant Studies

    Posted on 11/1/2013 10:03 AM

    The most developed and widely implemented concept of the CDISC standards is the Study Data Tabulation Model (SDTM). In 2010, the FDA’s Center for Drug Evaluation and Research published a data standards plan recommending CDISC standardization for the submission of clinical trial data. Utilizing the SDTM allows for greater efficiency of the regulatory review process. The SDTM benefits sponsors by enabling standardized processes and programming. The following process shows how the raw data is conv

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