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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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Ready to Submit Your Initial IND?

April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

I hope that you have read our previous blog posts on IND filing and have learned about the types of INDs, when you need to file an IND, and pre-IND activities. Continue reading this post to understand the process of submitting an initial IND and the subsequent IND-related steps to take as you proceed towards your marketing application.

Let us start with …

IND components

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Kathryn Tworkoski, PhD, RAC Promoted to Senior Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 27 Mar 2018 – In March 2018, Kathryn Tworkoski, PhD, RAC was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Kathryn joined the IMPACT family in November of 2014 as a Clinical Research Scientist. During her time at IMPACT, Kathryn has served as a writer in our early phase group, as well as for multiple NDA/BLA submissions, and has earned her Regulatory Affairs Certification (RAC). She has been lead writer on a diverse array of complex documents, including INDs, CSRs, IBs, protocols, narratives, submission summary documents, manuscripts, and IMPACT blog posts, across a wide range of therapeutic areas. Kathryn has consistently received positive feedback for the quality of her work and critical assessment of data both internally from her IMPACT colleagues and externally from Sponsors. She has also become a mentor and reviewer to junior writers and has always been willing to lend a helping hand to her colleagues whenever needed.

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Before you file your IND…

March 14, 2018 | Preeti Chugha, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

You’ve determined that you need to file an IND to conduct human trials in the US. What do you need to do before you submit your IND? While INDs can be opened at any stage of product development, the main focus of this post is on pre-IND activities for those being submitted to support first-in-human studies.

Nonclinical and CMC activities

During a new drug’s early preclinical development, it is necessary to determine that the product will not expose humans to unreasonable risk when used in limited, early-stage clinical studies, and that it exhibits pharmacological activity that justifies commercial development. To that end, nonclinical and chemistry, manufacturing, and control (CMC) data should be collected to include in an IND and support the initiation of a clinical trial. These components of an IND include:

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