Q-Sub- AI

08/08/2022

Independent consulting experience needed writing/reviewing Q-Sub/Pre-Sub for a device.

Product: This is an AI platform which functions as a risk assessment tool for maternal hemorrhage.

Timeline: Project would commence In August 2022 and extend over the next ~45days.

5 Comments on this article

  1. .

    Sheila here with an update on this project- this is for a consulting firm and an academic center that is pursuing an AI product- predictive model using the Centers EHR data to evaluate and assess risk of internal hemorrhage. The academic center is not familiar with FDA regs and submissions.

    They are not sure if the project will be writing of the Q-sub or possibly reviewing their writing.

    The consulting firm actually hasn’t been retained yet, they are bidding on it and hope to hear in the next couple of weeks. I’ll be back with updates.

  2. .

    Sheila here- update on this project- their “goal is to have a decision to move forward with the program mid to end of September, with this writing/reviewing project beginning 3-4 weeks post contract execution.”
    Interpretation- cautiously optimistic for a late October project start. Which can also mean a November or December project start! I will keep you posted.

  3. .

    Sheila here with an update- I pinged the hiring entity today as they mentioned they’d be ready to look at this again in mid-september, I will update here when I hear back.

  4. .

    Sheila here with an update on this project- I’ve checked a couple of times but haven’t heard back. Either they have found other help or the project is indefinitely delayed.
    I will let you know if this comes back to life but for now am closing this out. Please let me know if you have any questions!

    Sincerely,
    Sheila

  5. .

    Despite a strong and promising start this project seems to have fizzled, and despite repeated requests LifeSciHub hasn’t heard back. We suspect the client decided to not move forward with the project, as this was aspirational- they hadn’t fully committed to moving forward with a marketing application. However, we’re not sure. For now, closing this out, and thanks very much for your interest. If we hear back, we will be back in touch!
    Sincerely,
    Sheila

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