It’s been an exciting few months for me here at Clarity in Science Editing and Writing, as I have been expanding our business offerings. Specifically, I have been consulting for a small biotech company that is working toward submitting an Investigational New Drug (IND) application to the FDA in 2025 for their exciting new drug. Obviously, with the CDA we have in place, there is a lot I can’t say, but I can say that we have submitted a Pre-IND Briefing Document to the FDA and received a response, and now we are working to secure funding and are completing the regulated, cGLP-compliant non-clinical studies necessary to support that IND.
My work for them started as a technical writer and editor, where I assembled much of the Pre-IND BD, using my professional training to coherently assemble their published and unpublished data into a format that would make the most compelling story possible for the FDA. Since then, my work for the company has expanded a great deal, to include experimental design, grant writing (SBIR proposals, BARDA, NIH BAA responses, a Texas CPRIT proposal, etc.), assembling slide decks for venture capitol pitch proposals and marketing meetings, and now even project management.
FDA cGLP compliance regulations require a Study Director for all regulated studies, and this company has found that their principal scientists really do not have the time to function in this capacity, so it is saving them time and money to hire me as the Study Director of record for some of the investigations being performed at contract research organizations (CROs). With my background as a physician-scientist, I can offer a much higher level of skill and training than the typical technical writer can. Also, because they pay Clarity in Science Editing and Writing by the hour for my services, it is much cheaper for them than it would be hiring a full-time writer or a full-time scientist.
Given the success of this first consulting job, I thought I would post about it here, to offer this service to other biotech and pharma companies that may be in need of such a service. At this point, my intention is to handle all consulting services myself, within the broad areas of oncology, immunology, small molecules and cell signaling, and medicine. However, if you have a different need that is covered by the expertise of one of our subeditors, we could discuss hiring them through our company for consulting as well.
Reach out today at either of our email addresses: info@clarityinscience.com or clarityinscience@gmail.com, or call me at (713) 489-3572 to discuss your company’s needs, and let’s see if I can be of assistance. You’ll be glad you did.
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