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Professional Organizations for Emerging Medical Writers

February 8, 2017 | Jacquie Powell, PhD | Medical Writing Services

Attending professional networking events can seem intimidating, especially for graduate students and postdocs with limited professional experience outside of academia. This post provides a list of great professional organizations that some of the folks here at IMPACT have found to be particularly helpful, both nationally and in our local Research Triangle Park (RTP) area.

We hope you find this list helpful, and let us know if we missed anything!

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How to Use Social Media to Transition into Medical Writing

January 25, 2016 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Medical Writing Services

In the previous blog post, we shared advice on face-to-face networking for people (like you!) who are looking to transition into a medical writing career. In this post, I break down some of the available social media resources and pass along some advice I learned along the way to my current role at IMPACT.

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5 Professional Networking Tips for Emerging Medical Writers

January 16, 2017 | Jacquie Powell, PhD, and Ashley Godfrey, PhD, RAC, Clinical Research Scientists | Medical Writing Services

We have talked to a number of transitioning scientists who have a hard time understanding why they should engage in professional networking. One postdoctoral fellow summed it up by saying, “I know I should network but it just feels so dirty.” This made us laugh and helped us remember our own disconnect as we were going through the process of leaving academic science to enter the field of medical writing.

In an effort to help others bridge the gap, this blog post provides 5 professional networking tips we have learned along the way.

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IRB Meetings — Beyond The Regulations

December 15, 2016 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Regulatory Affairs

Have you ever wanted to know what goes on at a convened Institutional Review Board (IRB) meeting? What does the board talk about, how is each clinical research study evaluated, and what kinds of questions will the board raise before approving a study?

These were all questions I had when I joined a local IRB at a large institution.

The experience I had serving as a voting board member and discussing clinical research on the other side of the process has provided me with a valuable perspective.

I hope that sharing some of the things I have learned along with providing some general information about IRB regulations will shed some light on the IRB’s process of review.

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Final Rule Confirms, Posting of Study Results on ClinicalTrials.gov Will be Required for Unapproved Products

November 29, 2016 | Hazar Awad Granko, RPh, PhD, Senior Director, Regulatory Affairs | Regulatory Affairs

In a previous post, we told you about the National Institutes of Health’s (NIH) Notice of Proposed Rulemaking (NPRM) on expanded clinical trial registration and results submission on ClinicalTrials.gov. The Final Rule has now been issued and significantly expands the registration and results reporting requirements for clinical trials.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) required Sponsors of certain clinical trials to register on ClinicalTrials.gov, but only required results reporting for trials of drugs, biologics, or devices that were approved, licensed, or cleared by the FDA.

In a push for expanding transparency and advancement of public health, the NIH issued an NPRM in November 2014 proposing to expand these requirements. After receiving over 900 comments from various companies, organizations, and individuals, and nearly 2 years later, the NIH has now issued a Final Rule on clinical trials registration and results reporting.

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