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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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IMPACT’S Making an IMPACT Initiative Celebrates the Second Half of 2018

RESEARCH TRIANGLE PARK, NC: 06 February 2019 – In the second half of 2018, 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 Season of Giving.

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Beth Pultorak, PhD Promoted to Senior Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 30 January 2019 – In December 2018, Beth Pultorak PhD was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Beth joined the IMPACT family in June of 2016 as a Clinical Research Scientist. During her time at IMPACT, Beth has authored or contributed to a variety of complex CSRs, submission documents, and projects across multiple therapeutic areas and has earned the respect of her internal reviewers as well as some of our most critical Sponsor reviewers.  Over the past year, she successfully managed a strategic partnership with one of IMPACT’s largest clients. Beth’s eagerness to take on challenging projects, combined with her project management and statistical expertise, make her an excellent addition to any project team.

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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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