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KEEP ‘EM COMING: AN OVERVIEW OF IND UPDATES

June 2, 2020 | Kathryn Tworkoski, PhD, RAC  |  Principal Clinical Research Scientist  |  Regulatory Affairs, Medical Writing, Drug Development Consulting

In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of INDs.  In these earlier posts, we mentioned that INDs are “living” documents, which means that they are continuously being updated as a drug development program proceeds.  So today, we thought we’d take a few minutes to discuss the types of IND updates that you may come across.  Let’s start with…

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From Benchtop to Desktop: 8 Transferable Skills Learned in the Lab that Apply to Medical Writing

October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services

So you’ve decided to begin a career in medical writing – congratulations! Now what?

It may be scary leaving the comfort of your lab and pipettes, and medical writing may seem very different from academia, but you are more equipped for this transition than you may realize! (No, I’m not referring to your pipettes…)

Today, graduate students have access to several resources to help them break into the field of medical writing. While I encourage you to check these out, I also want to point out that you’re already learning valuable lessons at the bench that are applicable to any new job or work environment, including medical writing.

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Eight Things About Regulatory Medical Writing That May Surprise an Academic

August 30, 2019 | Nicole Tackmann, PhD, Clinical Research Scientist II | Medical Writing Services

The process of moving from the world of academia into the world of regulatory medical writing was an exciting and scary time for me. Luckily, I found a great place to make the transition, and I started my medical writing career at IMPACT in late 2017. At the time I thought that I had a pretty good idea of what regulatory medical writing was, but of course, I’ve learned a lot along the way!

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Statistics in Harmony: The Role of Estimands in Regulatory Writing

February 25, 2019 | Cheryl Ainslie, PhD, Clinical Research Scientist II | Regulatory Affairs Services

ich.org

In a previous post, I summarized the process by which the International Council for Harmonisation (ICH) creates harmonized guidelines for use by the pharmaceutical industry. Among the guidelines currently undergoing revision through this process is Efficacy (E) 9, Statistical Principles for Clinical Trials, which was initially released in February 1998. According to ICH, “This biostatistical Guideline describes essential considerations on the design and analysis of clinical trials, especially the ‘confirmatory’ (hypothesis-testing) trials that are the basis for demonstrating effectiveness.”

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Class of 2019: Inaugural Year of IMPACT’s Medical Writing Fellowship Program

January 28, 2019 | Laurel Kartchner, PhD, Amritha Kidiyoor, PhD, and Brandi Schuster, PhD, Medical Writing Fellows │ Medical Writing Services

More and more recent graduates want to break away from bench science but don’t know how or lack the industry experience that many pharmaceutical companies are now looking for. To facilitate this transition, some CROs like IMPACT have begun to provide fellowship and internship programs that offer hands-on experience for those moving from academia into a career in regulatory medical writing.

As of Spring 2018, IMPACT offers a unique full-time Medical Writing Fellowship with a goal of enabling aspiring scientists to become regulatory medical writers. The program is designed to focus on 3 main areas: 1) training and professional development, 2) quality control (QC), and 3) regulatory medical writing. This post summarizes our experience as the first group of fellows at IMPACT.

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