“I want to give myself as much time as possible to enhance clarity and check accuracy. That’s why I use PerfectIt on every submission.”

Kate McKiernan, San Diego

Challenge

Enhance the credibility of regulatory submissions by giving them a unified voice and the distinct look-and-feel of each company’s style guide while working to tight deadlines.

Solution

Use PerfectIt to check the mechanical details of each organization’s style guide in order to focus on accuracy, clarity, and usability.

Kate McKiernan, Medical Editor

Kate combines a graduate-level scientific background with professional writing qualifications. She can simultaneously check a submission for accuracy while making sure information is clearly presented to make the best impression on regulatory agencies including the FDA, Health Canada, and the European Medicines Agency.

Kate works for major pharmaceutical companies as they move from one stage of testing to the next. Each submission is prepared in AMA style. However, each company also has their own style guide, and Kate has to ensure each submission adheres to each company’s style guide.

Kate’s priorities are accuracy, clarity, and usability. She makes sure language is always clean and precise, and information is as easy to access as possible for the regulatory agency.

Offloading Mechanical Edits to Focus on Substance

Each pharmaceutical company and regulatory agency is on a timeline, so speed is critical in every submission. That’s why it’s crucial that Kate is not distracted by small details. She uses PerfectIt to check mechanical details such as:

  • Making sure each abbreviation is defined on first use.
  • Non-breaking spaces on measurements.
  • Italics for Latin phrases such as ‘in vivo’.
  • Capitalization consistency on specific phrases (e.g. “Day 3” versus “a day”).

Kate has added each of the different style guides that she works with to a PerfectIt style sheet. That means she can quickly switch from one client’s submission to another while knowing that their different preferences will be enforced by the software. Kate also plans to share the styles she has created with her colleagues at IMPACT Clinical so that the entire team can quickly check each company’s preferences.

“Each submission has multiple rounds of review, and PerfectIt saves me time on each of them. The result is a clearer, better submission.” – Kate McKiernan, Medical Writer and Editor

Offloading mechanical edits lets Kate focus on presentation, scientific accuracy, as well as the kind of substantive editing that no software can help with.

Professional Writers Give Submissions Credibility

A single embarrassing typo can irrevocably harm a submission. That’s because when agencies see typos, they don’t just question the writing. They question the underlying data. There is no better way to avoid embarrassment and enhance submissions than giving them the credibility that a professional writer and editor offers. Companies turn to Kate because she gives them that credibility.