Regulatory Open Forum

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  • 1.  eCTD publishing software recommendations

    Posted 11-Aug-2016 08:15

    I'd like to ask the Regulatory Open Forum community if folks have any recommendations for an eCTD publishing software vendor.  My CRO has been using Accenture (formerly Octagon) Quantum software for several years to do our eCTD publishing. Now Accenture has told us that they will be phasing out this business, so we need a new vendor.  We are a small or medium user, with 8 – 10 active INDs/NDAs/BLAs. We want to identify a vendor with easy-to-use and reasonably priced publishing software that we can license. Does anyone have recommendations or recent experience evaluating these vendors?  I'd love to hear about good it.  Many thanks!

     

    Kathryn Wekselman, PhD RN

    Senior Director, Regulatory and Scientific Affairs

    CTI Clinical Trial & Consulting Services

     

    w: 1.513.619.1889 | c:1. 513.748.1322 | f: 1.513.758.1710

    kwekselman@ctifacts.com | www.ctifacts.com

     

     

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  • 2.  RE: eCTD publishing software recommendations

    Posted 12-Aug-2016 08:49

    Dear Kathryn, 

    InSight Publisher from Liquent is best publishing tool currently many industry use. Speaking from my own experience, currently my firm use InSight Publisher 5.1 version that is user friendly and web based tool that can be accessible without citrix network. I would suggest have brief chat with Liquent folks to see type of price estimate they give to manage small load of products pipeline your firm has. I have managed many submissions ranging from pre-IND, Initial IND, Original NDA/BLA and postmarketing submissions. This tool is absoulately worth it to carryout submission publishing activity. Kindly please let me know if any support I can provide. My email is prakashpatel01@gmail.com. 

    I hope this was helpful, 

    Thank you and kind regards, 

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    Prakash Patel
    Sr. Regulatory Submission Management
    Roche (TCS)
    Midland MI
    United States

    Original Message


  • 3.  RE: eCTD publishing software recommendations

    Posted 12-Aug-2016 11:24

    Hi Kathryn,

    We just signed a 2 year contract with Accenture for eCTD publishing and software, so you may want to double-check with them on what you were informed. 

    In the past I've used a company called CSC (formerly ISI).  They have a software package called CTDExpress that works pretty well. 

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    Paul Long RAC
    Director, Regulatory Affairs
    Siga Technologies
    Corvallis OR


    Original Message