MMS Blog

  • 6 Features of a Statistical Analysis Plan that Can Improve Efficiency in the Programming Process

    Posted on 5/5/2015 12:13 PM

    A well written Statistical Analysis Plan (SAP) is a critical component of successful data analyses in clinical trials. The SAP further elaborates on the main features of the analyses described in the protocol, including a detailed description of how the statistical analysis of the primary, secondary and other endpoints should be executed. The SAP is an official regulatory document that represents an agreement between Clinical and Statistics regarding what analyses should be performed to address

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  • The Critical Role of a Regulatory Operations Specialist in a Successful Submission: 10 Key Success Factors

    Posted on 3/25/2015 12:17 PM

    For flawless submissions rooted in quality from the early stages of conception through successful execution and submission, a Regulatory Operations Specialist (ROS) can be considered the Captain of the Ship. Their role is not as simple as many consider it to be. A submission is not about attaching pre-written documents to an email and hitting the “Send” button on the FDA Gateway. It involves strategy and efficient operational skills for compilation, and minimizing the chances of errors that ca

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  • 10 Ways to Make Friends with ADaM (Datasets)

    Posted on 3/11/2015 12:22 PM

    Who is the new face of analysis dataset reporting in the pharmaceutical industry?  It’s ADaM (Analysis Data Model), a standardized dataset structure brought to us by CDISC and fully laid out for us in the Analysis Data Model Implementation Guide. ADaM datasets are the next step following SDTM (Standard Data Tabulation Model), which are datasets that display raw data in an organized, CDISC-compliant structure. So how else would we describe ADaM? Well, he’s a strong, powerful figure who represent

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  • MMS at PhUSE Conference March 15 – 17th in Silver Spring, MD!

    Posted on 3/10/2015 12:26 PM

    MMS will be attending the PhUSE Computational Science Symposium (CSS) conference in Silver Spring, Maryland on March 15-17th to present several posters, host a promotional booth, and attend the educational sessions. PhUSE brings together Regulators, Industry, Technology, and Service Providers to address computational science needs in support of regulatorPhUSE Logoy review. Representatives from several MMS functional departments will be in attendance, including Biostatistics, Programming, Clinica

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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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  • Risky Business: Pharmacovigilance and the Role of the NEW PSUR aka PBRER

    Posted on 1/28/2015 2:43 PM

    Pharamacovigilance (PV) is the multi-disciplined science of evaluating the risk benefit analysis of a pharmaceutical compound, which involves monitoring, detecting, assessing and preventing adverse effects of pharmaceutical products or medical devices. The ADR, or adverse drug reaction, is defined as any response to a drug which is noxious and unintended. Data gathered from patients and healthcare providers, as well as the medical literature, play a pivotal role in PV. Ultimately, PV is concerne

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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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  • One Small Secret to a More Successful Briefing Document

    Posted on 9/23/2014 3:27 PM

    Many of us who work in the pharmaceutical industry can recall excitedly explaining aspects of our science to friends and family. Perhaps the discussion took the form of a conversation of food effect around the thanksgiving table, or a detailed breakdown of a mechanism of action to a curious high school biology student. The questions that arise from discussions are often illuminating—allowing us to see science in a different way and helping us explain it more convincingly in the future. While dis

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