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How Technology Can Pave the Fastest Path to Compliance for Regulatory Submissions

By Litera Microsystems on November 1, 2018
Litera Microsystems

Patients waiting for life-saving drugs aren’t patient—and they shouldn’t have to be. While writers in other fields may have all day to produce content, every hour a medical writer delays a submission can extend a patient’s pain and suffering. Whether you’re working on life-saving stroke or heart disease treatments or life-enhancing therapies for rheumatoid arthritis or diabetes, you simply can’t afford to work slowly, nor can you throw caution to the wind and crank out sloppy documents. You need both a rapid turnaround and high-quality results—ideally, without burning yourself out in the process.

The good news is that technology can help you work as quickly as possible without sacrificing quality and while reducing the boring, frustrating parts of medical writing. That gives you time to focus on your real job: writing clearly and cogently so your reviewers can immediately understand your submissions. Let’s look at how.

Get to Submission Faster

Most of the grind for creating and submitting electronic common technical documents (eCTDs) isn’t in creating the text: it’s in reviewing the content and formatting. By automating the quality-checking process, you can rapidly create consistent paragraph styles and document formatting. You can identify key phrases and abbreviations and ensure that they are defined and correctly explained. You don’t have to check or cross-reference every table and figure manually. Instead of spending hours or days laboriously re-reading documents, you can let technology do it for you in mere minutes and make your eCTDs submission-ready that much faster.

We’ve had clients say that they now spend minutes on review instead of hours or that they’ve cut the time required for verifying submission compliance by 60 percent. Saving that kind of time enables medical writers to submit documents for review earlier—potentially speeding the process to deliver life-saving drugs to patients.

Don’t Sacrifice Quality

Obviously, you would never sacrifice quality or accuracy for faster review times. The good news is that you don’t have to: technology can simultaneously improve both the process and the results. Humans are imperfect reviewers. We get bored or distracted or, often, our minds fill in the blanks, causing us to read what we think is on the page instead of what is actually there. Technology does not get tired, wonder what’s for dinner, or assume that a sentence makes sense. It is the perfect workhorse, plowing through documents rapidly and unerringly.

In short, incorporating document technology allows pharmaceutical companies and others to improve their speed, consistency, and accuracy and complete a huge volume of medical writing faster than ever while actually improving formatting consistency and eliminating errors.

Avoid Burnout

But best of all is the third benefit of automation: when medical writers let technology take over the repetitive, boring, eye-crossing grunt work, they stave off frustration and burnout. Leveraging automation allows you to eliminate endless re-reading, which not only takes forever but has disappointingly imperfect results. Plus, taming the aggressive deadlines for medical writing by speeding up the QA process reduces stress and enhances job satisfaction. Instead of wasting time on repetitive, frustrating line edits and cross-checking, you can invest that time doing what you’re trained to do: streamlining and clarifying your content so reviewers can green-light your applications promptly.

Much of the process of regulatory approval is out of your hands, but by incorporating document technology, you can at least do your part as quickly and perfectly as possible and set your submissions up for success. If you want to hear more about how DocXtools for Life Sciences can help, get in touch today.

Topics: DocXtools, Life Sciences

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