MMS Blog

  • Bob Rappaport, M.D. joins the Board of Scientific Advisors for MMS Holdings, Inc.

    Posted on 8/19/2015 9:50 AM

    MMS Holdings, Inc. is pleased to announce the recent addition of Bob Rappaport, M.D. to their Board of Scientific Advisors. Dr. Rappaport will serve as a member of the Senior Leadership within the company. Dr. Rappaport will support and advise clients on scientific and policy issues. He will also guide and review work from internal MMS scientists as they draft regulatory submissions and other documents including briefing documents.

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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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  • DIA 2015: MMS Attends the Annual Meeting June 14-18th in Washington DC

    Posted on 6/12/2015 10:48 AM

    MMS will be in attendance at the DIA (Drug Information Association) 51st Annual Meeting June 14th – 18th in Washington DC to deliver an educational presentation and attend the sessions, workshops, poster presentations, town hall meetings, and networking events. DIA is the largest multidisciplinary event targeted to individuals in the discovery, development, and life cycle management of pharmaceuticals, biotech, and medicinal products. DIA’s goal is to foster innovation that will lead to the deve

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  • Pharmacovigilance Reporting in the US

    Posted on 6/1/2015 9:00 AM

    When a drug is finally brought to the market, it usually has gone through three clinical trial phases in humans, including Phase 1, 2 and 3 clinical studies. Some drugs may be required to conduct a Phase 4 or post-marketing study after approval in order to gather additional information about a product’s safety, efficacy or optimal use. Adverse events can occur in any of the clinical study phases (pre- or post-marketing), or when it has been marketed to the public after the drug’s approval. A ph

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  • ACRP Presentation: An Operational Plan for Clinical Trial Disclosures

    Posted on 5/21/2015 11:35 AM

    Joe Archer, Associate Director of Clinical Trial Disclosures at MMS Holdings, was in attendance at the annual Association of Clinical Research Professionals (ACRP) Global Conference & Exhibition in Salt Lake City, Utah on April 25-28th, 2015. The ACRP is the largest annual conference primarily focused on the conduct of clinical trials. The conference covers topics such as training, Quality Assurance, clinical trial operations, and clinical trial technologies, and the target audience is cli

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  • PharmaSUG 2015: MMS Attends the May 17-20th Conference in Orlando, FL!

    Posted on 5/13/2015 12:09 PM

    MMS will be in attendance at the PharmaSUG Annual Conference in Orlando, Florida on May 17-20th to present a poster and deliver an educational presentation, as well as attend the workshops, demonstrations, and networking events. PharmaSUG is the Pharmaceutical Industry SAS Users Group whose mission is to provide a forum for the exchange of information and the promotion of new ideas related to software and tools (including the SAS programming language) in the pharmaceutical industry. MMS will b

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  • 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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