The Critical Role of Quality Control (QC) – Medical Writing and Beyond

For many professionals in the clinical trial planning and execution phases of drug development, the quality control (QC) function is often considered to operate only to ensure the quality of documents prepared by Medical Writing. This is especially important, as the size of the medical writing industry is set to double by 2030 to reach $8.4 billion, according to a recent report from Grand View Research.

However, when you consider the various tasks that QC teams perform, it can start to become clearer that QC serves more than medical writing; it is an integral part of many different functions throughout a Sponsor and the pharmaceutical industry at large.

Consistent cross-functional deliverables

The specific tasks and processes involved in document QC can vary widely depending on the nature of the documents. Yet, at the heart of any QC project, the aim is to ensure that the document is accurate, consistent, clear, aligned with regulatory and template/style guidance, and is audience appropriate.

The tasks performed by QC to achieve this can be broken down into various categories, as detailed in Table 1 below.

When these tasks are considered separately, it is clear they can be applied to any document prepared by any function across the drug development landscape. Within the context of the pharmaceutical industry, QC should be included as a standard part of the process for all documents, whether it be for:

• Tables, Listings, and Figures (TLFs) or Statistical Analysis Plans (SAP) for Programming,
• Case Report Forms (CRFs) for Data Management,
• redactions for Transparency,
• Medical Monitoring Plans for Pharmacovigilance,
• Data Monitoring and Adjudication Committee Charters for Project Management, or
• Requests for Comments and Advice for Regulatory Affairs.

Quality control can of course be applied not just to Word documents, but for PowerPoint slides, posters, Excel spreadsheets, and the like. So, the next time you have a document to prepare, take time to stop and think, “what can QC do for me?”

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Authored by: Sharon Oyetunde, Manager, Regulatory and Medical Writing at MMS Holdings