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Category Archives: Medical Writing

Helpful Tips I Learned at the AMWA Carolinas Spring Conference

July 10, 2018 | Caroline Drucker, PhD, Clinical Research Scientist II  │ Medical Writing Services

In May, the Carolinas Chapter of the American Medical Writers Association (AMWA) held its annual spring conference at the Friday Center in Chapel Hill, NC. With this location convenient to Research Triangle Park, I was fortunately able to attend, meet other medical writers in the area, and learn about an array of topics from the 6 speakers and other attendees. The subjects ranged from the technical (efficient use of Microsoft Word) to the writing process (strategies for focused authoring, approaches for efficacy and safety summaries in marketing applications, and editing your own work) to the “softer” skills involved in medical writing (such as interpersonal interactions and working from home).

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The Why, What, When, Who, and How of Quality Control (QC) of Medical Writing Deliverables

May 15, 2018 | Nancy Gasper-Smith, PhD, RAC, Consultant, Medical Writing and Submissions Management and Head of Quality Control │ Medical Writing Services

Quality control (QC) is a term that applies across many industries. Within the field of regulatory medical writing, QC refers to the process of ensuring the quality and accuracy of a final medical writing deliverable.

In this post, I hope to answer many of the questions that our clients often ask us, such as: Why QC? What does QC entail? When should it occur? Who should QC?

Why QC?

The “why” of QC is straightforward – our goal is to deliver a document of the highest quality to our customers and it’s required by the guidance set forth by the International Council for Harmonisation (ICH):

“The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.” ICH E6: Guideline for Good Clinical Practice

The “who, what, and when” of QC are a little harder to define. What is QC? When should QC occur? Who should QC? As a regulatory medical writer who both writes and QCs on a daily basis, as well as leads the Quality Control department at IMPACT, I’m hoping I can shed some light on these questions.

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Tips for Effective Meetings – Getting the Most out of the Time Spent Together

December 20, 2017 | Elaina Howard, PhD, RAC, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services

Have you recently tried to schedule a meeting with your coworkers and found it difficult to find a time when everyone is available? If this is the case, then you know how precious the time together can be and how important it is to have effective and efficient meetings.

To put time spent in meetings into perspective, I often remind myself that while in a meeting, you are really using that time spent multiplied by the number of people in the room. That can be a lot of pressure to make good use of this time!

Not to worry, though; in this blog post, I’m going to suggest general meeting efficiency tips and I will also detail how I aim to get the most out of two common types of meetings for regulatory medical writers.

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Why and How to Conduct a Strategic Review of Regulatory Documents

November 16, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing and Corporate Communications | Medical Writing Services

As regulatory medical writers, we are trained on how to write for regulatory audiences, but how often are a Sponsor’s project teams trained to review the regulatory documents we write? At IMPACT, our answer is – as often as possible.

We encourage our project teams, as well as our internal staff, to use strategic review practices whenever possible, to ensure an effective, efficient review. We have trained internal and external reviewers accordingly, both with excellent results.

In this post, we’ll share the keys for an effective strategic review of regulatory documents. Please consider following these tips during your next review and let us know how it goes!

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CORE Reference for ICH E3 Clinical Study Report Authoring: Evolving with the Times

July 13, 2017 | Ilana Dew, PhD, Senior Clinical Research Scientist | Medical Writing Services

You may be a seasoned regulatory medical writer who has authored dozens of Clinical Study Reports (CSRs) and can recite the contents of the 1995 International Council for Harmonisation (ICH) E3 Guideline on the structure and content of CSRs with your eyes closed.

Or, you may be new to the profession. You’ve seen our blog series on getting started in the field, you have accepted a position in regulatory medical writing, and came here looking for some direction on how to interpret the ICH E3 recommendations and put together your first CSR.

Whether you fall into the former description, the latter, or anywhere in between, there’s something new that you are going to want to see.

It’s the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual, created to guide authors toward best practices for creating CSRs with new clinical trial transparency and disclosure regulations in mind.

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