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Category Archives: Medical Writing

Current Topics in Orphan Drug Development

December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist  │ Regulatory AffairsMedical Writing, Drug Development Consulting

Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases, INDs, preparation for pre-IND meetings, and the submission and maintenance of INDs.  But in October 2018, the FDA released new draft guidance outlining best practices for early drug development and pre-IND meetings for rare diseases.  Given the near-perfect cross-over potential, we thought this was a sign that it was time to review the guidance, as well as rare diseases as a whole.  So in the interest of appeasing the fates, let’s get this show on the road!

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Pro Tips for Protocol Writing

September 28, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist  │ Medical Writing Services

Great news; your team has been given the green light to conduct a new clinical study with your favorite compound!  It’s what you’ve been waiting to hear, and now it’s time to seize the opportunity and run full steam ahead!

But first, you have to write a protocol.  The basic structure and content of a protocol are described in the International Council for Harmonisation Good Clinical Practice E6 guideline.  As you would expect, protocols should ultimately outline and justify the planned clinical study.  The type of information presented in protocols includes background information, trial objectives and assessments, trial design, subject selection and treatment, and a brief overview of the planned statistical analyses.

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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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