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Author Archives: Nancy Smith

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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What Does a Regulatory Medical Writer Do All Day?

August 11, 2016 | Nancy Smith, PhD, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services

In my last post, I explored my transition from the bench to regulatory medical writing. I knew little about medical writing when I started, but quickly learned that it’s is an exciting mix of summarizing data, educating your clients/teams on regulatory considerations, and becoming a bit of a social dynamic expert.

In thinking about the best way to tell you what regulatory medical writers do each day, I thought that walking you through the potential career progression of a medical writer may be the best way.

That way you can see that it’s way more than just writing…and if you like what you read, then maybe this is a career option for you!


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Case Study: My Transition from the Lab Bench to Regulatory Medical Writing

July 28, 2016 | Nancy Smith, PhD, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services

The love of science is what gets most of us through the long days of graduate school and post‑graduate research. What happens when you still love the science, but not working at a lab bench?

There are alternative careers that allow you to be a scientist every day, but without the frustrations associated with academic research. This is the story of my transition into regulatory medical writing – a fulfilling, collaborative career that fuels my passion for science outside the academic arena.

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