MMS Blog

  • Case Study: Fast Track Designation

    Posted on 3/1/2016 10:00 AM

    Challenge: Small Pharma Requests Regulatory Writing Support for Anti-Infective Agent A small pharma company was seeking a Fast Track designation for their anti-infective agent to provide more frequent FDA interaction and a rolling review of program submissions.  Also, as part of the Pediatric Research Equity Act, the anti-infective program was required to have a plan for pediatric studies prior to the NDA submission. They were in need of regulatory writing support for the submission documents,

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  • Inconsistent Data Disclosure and Lack of Compliance across Big Pharma

    Posted on 12/14/2015 10:00 AM

    Both the Food and Drug Administration (FDA) and independent research groups have highlighted the lack of compliance with laws (2007 FDA Amendments Act) mandating that clinical trial data for approved products be disclosed to publicly accessed websites.  Furthermore, findings of a study published in BMJ Open indicate that the clinical trial data disclosed by leading pharmaceutical companies is inconsistent both across trials and across companies. Contributing factors to the noted lack of complia

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  • Upcoming Oncology Treatments: How close are we to a Cure?

    Posted on 12/8/2015 11:37 AM

    Or rather “cures.”  Cancer is a not a single disease, but rather a complex set of diseases that consists of various genetic mutations, protein overexpression or loss of protein expression/activity. Therefore, a number of different treatment options need to be available to address not only the type of cancer (breast, prostate, etc.), but also the biochemical characteristics of that particular cancer (eg, loss of PTEN expression, overexpression of HER2). Such commonalities in disease among patient

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  • 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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