We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.
QSS helps companies translate clinical trial data into clear, accurate regulatory documents and develop health claims that are properly substantiated and compliant with agency requirements. If you need a clinical study report, a peer-reviewed manuscript, or support building a defensible claims strategy, we can help.
Clinical trial data only generates value when it is communicated clearly, accurately, and in a format regulators and journal editors can act on. A clinical study report that does not meet agency standards, or a health claim that is not supported by adequate evidence, creates problems that extend well beyond the document itself.
At the same time, health claims are one of the highest-scrutiny areas in product compliance. The FDA, Health Canada, and other agencies have specific requirements for what claims can be made, what evidence is required to support them, and how they must be disclosed on labelling and in marketing materials. A claim that cannot be substantiated is a liability, and one that is overstated can trigger enforcement action.
QSS supports both sides of this work, from the scientific documents that report what your trial found to the claims strategy that determines how those findings can be communicated to consumers and regulators.
We prepare the clinical study report summarizing your trial’s design, conduct, and results in line with ICH E3 guidelines and the submission requirements of your target regulatory agencies.
We assess the evidentiary basis for your proposed health claims, review the scientific literature and your clinical data, and prepare substantiation dossiers that demonstrate your claims are supported by competent and reliable evidence.
We review proposed claims for compliance with FDA, Health Canada, and applicable international requirements, identifying claims that are permissible, those that require modification, and those that carry regulatory risk.
We develop original manuscripts for submission to peer-reviewed journals, translating your clinical data into clear, scientifically rigorous papers that meet journal requirements and Good Publication Practice standards.
We prepare clinical sections of regulatory submissions, including Common Technical Document (CTD) clinical summaries and equivalent documents for Health Canada, FDA, and international agencies.
We develop abstracts, poster presentations, and slide decks for scientific conferences, ensuring findings are communicated accurately and compellingly to a scientific audience.
We review and edit pre-written clinical documents and claims materials for scientific accuracy, regulatory compliance, clarity, and consistency before submission to agencies or journals.
Explore articles, blogs, and videos on health claims substantiation, clinical study reporting, and regulatory writing.
Permissible claim types vary by jurisdiction and product category. In the U.S., the FDA distinguishes between structure/function claims, health claims, and qualified health claims, each with different substantiation and disclosure requirements. Health Canada has its own framework for permitted claims on foods and natural health products. We assess your proposed claims against the applicable framework and advise on what is permissible, what requires modification, and what evidence is needed to support each claim.
Substantiation requires demonstrating that your claim is supported by competent and reliable scientific evidence. This typically means reviewing the relevant clinical literature, assessing the quality and consistency of available studies, and preparing a dossier that presents the evidence in a structured, defensible format. We conduct the review and prepare the substantiation package on your behalf.
A Clinical Study Report is a comprehensive document summarizing the design, conduct, and results of a clinical trial. It is required as part of regulatory submissions to agencies such as the FDA and Health Canada and must be prepared in accordance with ICH E3 guidelines. It is the primary document linking your trial data to your regulatory application.
Yes. A Clinical Study Report is a regulatory document intended for agency review. A peer-reviewed manuscript is a separate scientific communication intended for the research community and must meet journal-specific requirements that differ from regulatory format standards. We support both and can develop them in parallel.
Good Publication Practice (GPP) is the set of ethical and methodological standards governing how clinical research is reported in scientific publications. GPP requires that publications accurately represent the data, that authorship is assigned appropriately, and that financial or other interests are disclosed. Regulatory agencies and journals both expect GPP-compliant publications.
Yes. We have direct experience with the claims frameworks of both Health Canada and the FDA and can assess your claims across both jurisdictions, identifying where requirements align and where they differ so your labelling and marketing materials are compliant in each market.
We assess your evidence honestly and advise on what the data can and cannot support. In some cases, a modified claim may be defensible where the original is not. In others, we can identify gaps in the evidence and advise on what additional data would be needed to substantiate a stronger claim. We do not prepare substantiation for claims the evidence does not support.
Talk to a specialist about your IVD device registration pathway, whether you are determining classification for the first time or preparing a 510(k) for the U.S. market.