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What Defines Quality in Medical Writing?

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A quick trawl of the internet reveals that the majority of medical writing services are sold, in part, on the basis of quality, but what really is quality and why do medical writers think it is so important?

We believe that the definition of quality is largely dependent on the perspective of the individual. A project manager or budget holder might define a high quality deliverable as one that is fit for purpose, delivered on time and within budget, but to a writer or reviewer it is likely the detailed content of the document and how it is presented that are most important.  Good medical writing services will strike a balance between well written, accurate, purposeful documents, and cost.

Ultimately, quality is only important if it leads to a better document, and so quality and how you achieve quality for a particular document, should be considered before any writing begins.

Often medical writers get caught in the quality trap, checking whether there are 1 or 2 spaces after a full stop, spending hours checking the abbreviations list, capitalization of Visit, or not, and while these elements lead to a document which can be easily read, they do not confer quality alone. And so, it is important to consider that different documents require different checks.  Focused quality checks should be based on the type of document being written and its final use/audience. While all data points should be checked against source, does a 2 page document to be distributed internally need to be checked against the full company quality control (QC) checklist, it will never
be audited. Equally, does a common technical document (CTD), need to have all of its components rechecked, if the source information has already been fully QC checked?  Might time be better spent focusing on accuracy of message, structure, succinctness, and consistency?

Measuring quality can also be challenging. Some measures are relatively straightforward, for example, a good quality protocol should have minimal investigator/site queries and allow for the efficient production of a clinical study report (CSR). Document delivery can be measured with respect to timeliness, client feedback, and rework.

Rework after finalization can occur for a number of reasons, 1) a change to the development strategy requiring substantial changes; 2) the document is rejected or changes are requested by a regulatory authority; 3) misunderstandings or incorrect data interpretations; and 4) typographical errors.  The first two reasons are unlikely to be the fault of the writer and would not necessarily be considered the result of a poor quality document; the last two however point directly to poor writing and are an important metric to collect. Furthermore, a good medical writer can help a Sponsor with their development strategy, by identifying potential gaps/unanswered questions and considering the downstream documents. 

Why do quality rich documents matter? Simply put, a quality document will save money. True quality occurs when a document has achieved its purpose, whether that is presenting results in a succinct and clear fashion according to the original objectives or the description of a process without ambiguity.  If a study protocol is designed and written well then the study results will be robust, few letters of clarification or amendments will be required, and the CSR will be easily produced.  All of these aspects will save the Sponsor both time and money.

So perhaps, when discussing quality with a potential vendor, don’t concentrate on their quality control checklists or process; ask how they would define high quality for your document, and how they would achieve this.

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Quanticate offers a wide range of Medical Writing services including clinical and regulatory writing in support of any or all stages of the pharmaceutical development life-cycle. Our Medical Writers deliver accurate, timely and cost effective documents to the highest of ethical and scientific standards. Please submit a request for information (RFI) if you would like to speak to a member of our team who can support your trial.


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