High-quality medical writing (MW) underpins the credibility, accuracy, and compliance of clinical and regulatory documents submitted to health authorities. In drug development, even a single error in data, formatting, or interpretation can delay approvals, undermine credibility, or compromise patient safety.
Whether drafting Clinical Study Reports (CSRs), protocols, Investigator’s Brochures (IBs), or lay summaries, every word, number, and citation must withstand rigorous scrutiny. Regulatory documents are developed through an iterative process, with multiple drafts written and refined to produce the most accurate and complete version within the agreed timelines and regulatory purpose.
A robust Quality Control (QC) and review framework ensures that medical writing deliverables are scientifically sound, inspection-ready, and fully compliant, reinforcing both regulatory confidence and the organisation’s reputation.
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.
Quality Control in Medical Writing: Definition and Scope
Quality control in medical writing is the formal, documented verification that a deliverable is complete, accurate, consistent, and aligned with source data and regulatory expectations. Unlike authoring, which involves scientific interpretation and drafting, or editing, which refines clarity, structure, and tone, QC is a structured, independent process focused on factual accuracy, consistency, and compliance.
All data presented in clinical documents must be retrievable and verifiable from original sources. QC confirms this traceability.
Its scope covers a wide range of document types such as:
- Clinical documents such as CSRs, narratives, protocols and protocol amendments, investigator’s brochures (IBs) and IB updates, and lay summaries
- Regulatory modules including Module 2 summaries, overviews, CTD sections, and integrated summaries of safety (ISS) and efficacy (ISE)
- Safety and pharmacovigilance reports including RMPs, PSURs, DSURs
- Scientific publications and manuscripts
For documents such as protocols, where detailed source materials (e.g. TFLs or prior study data) may not be available for verification, the QC focus shifts. In such cases, QC ensures internal consistency across sections, alignment between the Synopsis and the main Protocol body, and consistency and accuracy of the Schedule of Activities (SoA) with corresponding sections such as study design, assessments, and endpoints.
While a document may have only one primary writer, it often involves multiple contributors, each bringing edits, data updates, or annotations. Without proper version control and traceability, this can lead to sourcing errors, untracked edits, or confusion over which draft is the most current. Discovery of such inconsistencies or data errors by regulatory reviewers, even in a few documents, can erode confidence in the reliability of the entire submission.
Therefore, a rigorous QC process is not merely a safeguard but a critical pillar of scientific and regulatory credibility. It helps ensure that every submission reflects the organisation’s commitment to accuracy, transparency, and consistency.
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, capitalisation 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?
QC Process in Medical Writing: Stages and Deliverables
An effective QC process follows a structured, traceable, and documented pathway to ensure quality, consistency, and regulatory readiness.
1. Planning
QC expectations, reviewer assignments, and checklists are defined at project initiation.
2. QC Execution
- Process Adherence
QC is performed in accordance with standardised operating procedures (SOPs) and QC checklists.- Content Verification
Information is cross-checked against source materials such as TFLs (tables, listings, figures), protocols, prior documents, or as per the defined QC scope. QC comments are added directly within the document.
- Cross-Referencing and Consistency Check
The QC reviewer ensures internal consistency within the document and alignment across related documents. For critical documents like protocols or summary reports, consistency is essential to prevent discrepancies that could lead to protocol deviations, safety issues, or regulatory queries.
- Formatting and Style Review
Regulatory agencies and sponsor organisations often have specific formatting and stylistic requirements. QC ensures adherence to templates and style guides, verifying accuracy in hyperlinks, headings, numbering, tables, and figures.
- Resource and Timeline Management
If QC review requires more time than initially estimated, it should be flagged early so that potential solutions, such as redistributing work among multiple QC reviewers, can be explored to maintain timelines and efficiency.
- Content Verification
3. QC of QC by Senior Reviewer
A senior reviewer assesses the QC- checked document to ensure the completeness, accuracy, and quality of both the QC and its comments. This serves as an internal quality assurance step.
4. Consolidation and Proofing
Corrections are implemented and verified. A final proof ensures formatting accuracy and consistency before document release. Each stage produces tangible deliverables—QC logs, review comment trackers, and documented sign-offs—to support audit readiness. The QC reviewer then provides the QCed document and checklist to the sponsor medical writer or designated point of contact (PoC).
5. Verification of QC Comments Addressed
The QC reviewer performs a follow-up check to confirm whether QC comments have been addressed accurately. Any unaddressed or rejected comments must be justified. This verification is performed only if included within the defined QC scope.
6. QC Checklist Sign-off through Electronic Signature
Once the QC checklist is complete, the QC reviewer provides an electronic sign-off using secure tools such as Adobe Acrobat Signature. This eliminates the need for printing and scanning physical copies while ensuring traceable, compliant, and efficient digital management of QC documentation.
QC Reviewer Roles and the “Fresh Eyes” Principle
QC reviewers bring a “fresh eyes” perspective, reviewing the document independently from the author to detect gaps, inconsistencies, and errors that may have gone unnoticed. Reviewer independence is key to maintaining objectivity and ensuring an unbiased assessment of the document’s quality.
Collaboration and Accountabilities
QC reviewers perform line-by-line checks of data, citations, and structure. Authors respond to findings and clarify intent where needed. Project leads allocate QC resources and align reviews with timelines. This clear split of duties avoids conflicts of interest while maintaining speed.
QC Sources, Tools, and Checklists for Medical Writers
QC depends on a well-organised source pack and structured verification tools. Common QC sources include:
- Statistical outputs – tables, figures, and listings (TFLs)
- Study reference documents – protocols, SAPs, prior CSR versions, and data clarification forms
- Style and reference guides – company templates, regulatory style guides (e.g., EMA, FDA), and publication standards
- Cross-functional inputs – review feedback from clinical, biostatistics, and regulatory teams
QC checklists are typically organised into core categories:
- Text and data verification
- Internal and cross-document consistency
- Formatting, abbreviations, and citations
- Style and template compliance
- Document-specific checks
These tools standardise the QC process, enabling traceability and audit readiness.
Digital Quality Control in Medical Writing: Benefits and Caveats
The transition to digital QC tools, including shared document platforms, automated consistency checkers, and version-controlled workflows, has streamlined collaboration and traceability. Benefits include faster reviews, clearer tracking, enhanced auditability through automated version logs and timestamps, and easier collaboration across dispersed teams.
However, digital QC tools do not replace human judgement. Manual verification remains essential for evaluating scientific logic, contextual accuracy, and regulatory alignment, areas where automation may miss nuanced inconsistencies.
Quality Control in Medical Writing: Alignment with Regulatory Expectations
Regulatory agencies such as the EMA, FDA, and ICH expect documentation to demonstrate data integrity, traceability, and consistency across submission components. QC processes ensure alignment with these expectations by verifying that data and conclusions are traceable to source documents and validated outputs, ensuring document structure and style follow agency-recommended formats, and supporting inspection readiness through well-documented review trails.
While QC teams need not quote specific guidance, their practices must reflect current, consensus-based regulatory standards.
Quality Control Metrics: Measuring Effectiveness and KPIs
Effective QC systems rely on measurable performance indicators to assess quality and efficiency. Common QC metrics include:
- Defect rates – number and severity of QC findings per document
- Rework time – time spent resolving QC comments
- Cycle time– duration between draft delivery and QC completion
- QC Turnaround Time (TAT)– time taken by the QC reviewer to complete the assigned QC review, as defined in the project-specific SLA
- Defect escape rate – errors detected post-QC during later reviews or audits
Tracking these metrics allows continuous improvement, resource optimisation, and proactive identification of training needs.
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 finalisation 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.
Programme-Level QC Consistency Across Documents
Beyond individual documents, programme-level QC ensures consistency across related deliverables which is critical for submissions containing multiple, interlinked components. Practical cross-checks include verifying:
- Consistent terminology, data points, and interpretations across modules (e.g. protocols, CSRs, IBs, and overviews)
- Alignment of efficacy and safety narratives between the CSR and Module 2 summaries
- Harmonised abbreviation lists, table numbering, and figure labelling
This integrated QC approach maintains coherence and strengthens regulatory confidence in the submission package.
Data Integrity in QC: Links with Biostatistics and Programming
Data integrity is at the heart of medical writing QC. Every figure and statement should be traceable to verified sources. Close collaboration with biostatistics and programming teams ensures:
- Cross-verification of reported results against TFLs and underlying datasets
- Confirmation of consistency between statistical outputs and narrative interpretation
- Documented cross-functional sign-offs to support traceability and accountability
This interconnected QC model minimises discrepancies and reinforces the reliability of submitted data.
Timelines and Handoffs
Efficient QC depends on early planning and clear handoffs between writers, QC reviewers, and other stakeholders. Establishing timelines upfront allows teams to:
- Schedule reviews in alignment with deliverable milestones
- Define materials readiness criteria before QC initiation
- Maintain feedback loops and track resolutions to closure
A structured timeline reduces last-minute rework and ensures a smoother path to final approval.
Best Practices in Quality Control (QC)
An effective QC process is not only about identifying errors but also about communicating them clearly, constructively, and with supporting evidence. Following best practices ensures that QC findings are meaningful, actionable, and help improve the document efficiently.
Key best practices for QC reviewers include the following:
- Add QC findings as bubble comments with Track Changes enabled
Record all observations using comment bubbles in Microsoft Word while keeping the Track Changes function on to maintain full visibility and traceability of suggested edits. - Prioritise critical findings first:
Highlight critical issues, such as data inconsistencies, incorrect interpretations, or regulatory non-compliance, before flagging minor findings like typographical or formatting errors. - Be specific and precise
Clearly identify the nature of the issue and indicate its location within the source document (e.g. Protocol Section 4.2.3). Specificity helps the writer quickly locate and resolve the issue. - Provide evidence-based comments
Each QC finding should be supported by a verifiable reference such as a table, listing, figure (TLF), template, guideline, or style guide. This strengthens the credibility of the feedback and facilitates accurate corrections. - Use global comments for recurring issues
If the same error appears multiple times, document it once in a global comment and reference that note in subsequent instances. This reduces redundancy while maintaining thoroughness. - Suggest solutions where possible
Offer practical suggestions to resolve identified issues. Providing clarity on how to correct an error helps the medical writer address comments efficiently and consistently. - Provide context and rationale
Briefly explain why something is an issue. For example: “This statement contradicts the data presented in the synopsis or the protocol.” Contextual comments improve understanding and reduce the likelihood of repeated errors.
By adhering to these practices, QC reviewers not only identify issues but also contribute meaningfully to the clarity, accuracy, and efficiency of the medical writing process.
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.
Conclusion
Quality control and scientific review are integral to the credibility, compliance, and success of medical writing deliverables. By following structured QC processes, maintaining independence and collaboration, and aligning with regulatory and scientific standards, writing teams produce documents that are accurate, audit-ready, and reliable.
A disciplined QC process minimises risk, enhances reviewer confidence, and supports faster regulatory approvals. Ultimately, QC transforms medical writing from a documentation exercise into a quality-driven, value-adding function that enables transparent, trustworthy, and timely regulatory submissions.
For pharmaceutical companies, partnering with writers who prioritise rigorous QC practices provides a strategic advantage that delivers lasting impact across every phase of drug development. When discussing quality with a potential vendor, ask how they would define high quality for your document and how they would achieve it, rather than focusing solely on checklists or process.