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  • 1.  Regulatory Information Management (RIM) system

    This message was posted by a user wishing to remain anonymous
    Posted 17-Aug-2022 16:12
    This message was posted by a user wishing to remain anonymous

    Hello, 
    I am interesting in ballpark costs for a Regulatory Information Management (RIM) system (software costs and annual maintenance fees). 
    Thanks


  • 2.  RE: Regulatory Information Management (RIM) system

    Posted 18-Aug-2022 12:32
    Edited by Sara Saunders 18-Aug-2022 12:32
    Hello, 

    I am currently the Policy Manager at Florence Healthcare - Here is a link to our website where you can find additional information on how Florence can assist with clinical trial regulatory workflows. If this is in line with what you are looking for in a RIM system, please let me know and I can get you in contact with our sales team to provide information on costs and other details. 

    Best, 

    Sara Guyler

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    Sara Guyler
    United States
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    Original Message


  • 3.  RE: Regulatory Information Management (RIM) system

    Posted 21-Aug-2022 17:04
    Your costs will be driven by your user requirements, i.e., what you expect from a RIM. In addition, there is also the capacity [how many users will need to interact with the system?] and then the scalability issue [it is one thing to plan the system today for your current users; the key question becomes can the RIM expand if your business expands?].  finally, do you have a functioning esubmissions tool already or are you looking for an end to end solution? [submission document control to e-publishing and then on to final controlled archival meeting 21 CFR Part 11]. Going for the least expensive system today may cost you mega $ at the time of migration, in the future.  Most systems need to be 'migrated' every 4+ years; this assumes the vendor is a "long term player" in the RIM space. You do not want to invest heavily in any system that will be outdated in 4+ years, or be stuck with a system where users must do a lot of 'work arounds' to interface with it, in 2027. Lorenz Lifesciences is one company that has stayed in the regulatory - RIM - space consistently since the late 1990s, with high quality staff and product offerings in the RIM space. I used Lorenz products successfully between the early 2000s and 2010, when I retired from full-time RA work. Lorenz assisted us in compiling 2000 eCTD sequences as of March, 2008; this represented over half of all eCTDs sent to FDA  during FY 2008-09. I have no financial ties to Lorenz; just an interest in helping folks sort out the key players as the move is made to total "e".

    ------------------------------
    S. Albert Edwards FRAPS
    President, eSubmissions University
    Lincolnshire IL
    United States
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    Original Message


  • 4.  RE: Regulatory Information Management (RIM) system

    Posted 22-Aug-2022 07:08

    Hello, 
    unfortunately you can't give a standard price for a RIM system, as it really depends on user requirements, number of active users, different interfaces (if required), migration or re-deployment needed, whether you use the default version or need customization, etc. The annual maintenance fee will depend on what service level agreement you have with your vendor, whether you choose managed as a service or on-premise management.

    Before choosing a vendor, clarify what your expectations are for the system and what you want to accomplish with the system. Then, you should organize some demo sessions with vendors to see if this meets your expectations. After all, you won't switch from one RIM system to another in a heartbeat.

    kind regards

    Henrike 



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    Henrike Miess
    Böblingen
    Germany
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    Original Message


  • 5.  RE: Regulatory Information Management (RIM) system

    Posted 22-Aug-2022 09:02
    Hi,

    As stated within this post the cost depends on numerous factors (number of products, countries, etc.).  If you are in the Medical Device/MedTech industry, I highly recommend you check out Rimsys https://www.rimsys.io/.   I have been in the Medical Device industry for over 25 years in Quality and Regulatory.  I was very impressed with Rimsys and how they have established a solution specifically for the MedTech RA professional, that I ended up leaving industry to join them.  Check it out and if you have any questions let me know.

    Bruce

    ------------------------------
    Bruce McKean
    Director of Regulatory
    Rimsys Inc.
    Pittsburgh, PA
    USA
    bruce.mckean@rimsys.io
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    Original Message


  • 6.  RE: Regulatory Information Management (RIM) system

    Posted 22-Aug-2022 09:25

    Anon:

    Could you specify exactly if you are intending 'RIM'  to mean 'eQMS" or more than what an eQMS provides? Not really clear where one starts and ends then the other begins in the grans scheme of regulatory compliance.

    If eQMS is equivalent to RIMS with your definition/ reference on  this post, be sure to look at Qualio as well www.qualio.com - rated independently as one of the best, highly configurable, seamless process based user interface, enhance integration with external systems, and more importantly geared towards small-to-medium sized companies.

    We referenced Qualio to another company (RAPs member) that acquired it, they claim it's meeting their expectations and then some.
    Send me questions if needed on a one to one, private messaging basis-will assist if I can further.


    Ram Balani



    ------------------------------
    Ram Balani
    CEO
    FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
    Amawalk , New York
    rbalani@fdasmart.com
    2019130558
    https://tinyurl.com/2wkxp69y
    on US FDA eSTAR for 510(K)
    ------------------------------

    Original Message


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