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Three Essentials for a Good Clinical Study Report

The Clinical Study Report (CSR) is often a key document in the transition from concept to marketability for medical devices. A CSR brings together the relevant background, methods, results and conclusions of a device’s clinical study. It may be required for your medical device’s approval by a regulatory body, used internally for strategic development, utilized for external marketing or even for investment purposes. But what makes a good CSR, and why is it so important?

Regardless of use, writing a good CSR is critical to its value and impact. No matter how safe and effective your device may be, misplaced data or incoherent storytelling mar a CSR’s ability to capture the study’s industry relevance. At NAMSA, we believe three components are especially important to creating a compelling CSR: accurate details, narrative cohesion, and cross-functional expertise.


Accurate Detail

Accuracy is paramount. Yet, tables are often left unexplained or contradict other portions of the report. Clinical studies collect a large amount of data into one document, which comes from many different groups. A strong working relationship between the statistician and medical writer can facilitate accurate tables and clear communication about the statistical outcomes. Moreover, it is essential to cross-check the CSR data with the original Clinical Investigation Plan (CIP) and the Statistical Analysis Plan (SAP) to ensure all planned analyses have been executed. Deviations from either the CIP or SAP should be adequately explained, along with the reasons for any additional or unplanned analyses. All tables must be cross-checked against each other with inconsistencies explained, such as differences in denominators. If there were unexpected results, then they need appropriate context. A clear acknowledgment of the study’s limitations is also helpful.


Narrative Cohesion

Getting the details right isn’t enough, of course. Without the appropriate context, no amount of precision will amount to clarity. In addition to accuracy, a good CSR requires a cohesive narrative. Don’t let extraneous information—while often useful—become a distraction. Keep the main body of the report focused on the main ‘story’ by putting long tables (>1 page) and additional statistical analyses into the appendices. Supplementary information works well in appendices, where curious readers can find it.


Cross-Functional Expertise

Statisticians, regulatory specialists, physicians and the clinical operations teams are all vital members of the expert team that creates a CSR. In a high-quality CSR, cross-functional expertise is leveraged so the entire study is condensed into a clear, cohesive document without any gaps. Our medical writers routinely work closely across functions to leverage the various experts we have at NAMSA to ensure a quality document that meets regulatory standards.


Perhaps you have data from previous studies that could be wrapped up into a compelling story? Let NAMSA use our varied fields of expertise and years of medical writing experience to help you tell the story of your clinical study. Contact us to discuss your needs.

Britta Rupp, PhD

Britta is an accomplished professional with 20 years of research spanning multiple scientific disciplines. Her journey in the medical device industry began at NAMSA in 2015 as a preclinical study director. She then transitioned to the realm of regulatory medical writing in 2019. Britta has a PhD in neuroscience and a depth of experience in various therapeutic areas, including neuromodulation, cardiovascular/endovascular and endoscopy/gastroenterology. She has spent the last 5 years writing regulatory documents covering all classes of medical devices and has expertise in both EU and US regulations.

Dan A. Whitter

Dan has been in the industry for 25 years, with 16 years focused on medical devices. He has experience in a variety of therapeutic areas, including: wound care, orthopedics and reconstructive surgery. His expertise covers all aspects of clinical research, including study design, set-up and execution of global studies, from small first-in-human studies to large observational registry studies.