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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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IMPACT’S Making an IMPACT Initiative Celebrates the First Half of 2019

RESEARCH TRIANGLE PARK, NC: 19 August 2019 – In the first half of 2019, IMPACT’s employees continued their generous efforts via the Making an IMPACT (MAI) community service initiative. Together, we held several donation drives for various charities, as well as our annual March Madness charity bracket contest.

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Cheryl Ainslie, PhD, RAC Promoted to Senior Clinical Research Scientist

In March 2019, Cheryl Ainslie, PhD, RAC was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc (IMPACT).

Cheryl joined IMPACT 1 year ago and has quickly established herself as a consummate professional, and a very reliable and capable member of our team! Cheryl has worked on a variety of documents, including CSRs, protocols, and IBs, as well as some more unique projects. Recently, Cheryl began co-managing an IND safety reporting project as well as senior reviewing and mentoring our newer writers.

In recent months, Cheryl passed her RAC exam and co-founded the IMPACT on Literacy. Outside of her project work, Cheryl is helping to develop a statistics lunch and learn and will be teaming up with Making an IMPACT to host a book drive as part of the IMPACT on Literacy Book Club.
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Ryan Overcash, PhD Promoted to Senior Clinical Research Scientist

In March 2019, Ryan Overcash, PhD was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc (IMPACT).

Ryan joined IMPACT in March of 2016 as a Clinical Research Scientist. Within his first year, Ryan managed a very large safety narrative project, a role during which he developed excellent project management and mentorship skills. More recently, Ryan managed a growing IND safety reporting project. He developed a great rapport with the client, which ended up leading to a new IND project for our early phase group. During his time at IMPACT, Ryan has also been involved in writing numerous protocols, several large IB updates, and CSRs, as well as non-clinical modules of an sNDA.

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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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