A Clinical Study Report (CSR) is one of the most important documents produced in the course of a clinical trial. Required for regulatory submissions such as INDs, BLAs, and NDAs in the US—and by global authorities including the EMA and Health Canada—a CSR presents a comprehensive account of the methods, conduct, and results of a clinical trial.
More than a summary, the CSR must interpret data clearly and objectively, demonstrate adherence to protocol, and provide enough detail to allow regulators to assess the trial's integrity and outcomes. Poorly written CSRs can lead to regulatory questions, delays, or even rejection. High-quality CSR writing is essential for getting your product one step closer to market approval.
A CSR is required for any interventional clinical trial intended to support a regulatory submission. In the United States, CSRs support Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologic License Applications (BLAs). In Europe and other regions, they are included in Marketing Authorization Applications (MAAs).
Regulatory agencies expect CSRs to follow the ICH E3 guideline, which outlines both the structure and level of detail expected in these reports. Compliance with ICH E3 is not optional—it ensures your document includes the context, methodology, and data interpretation regulators need to make informed decisions.
The ICH E3 guideline lays out a standardized format for CSRs that includes:
Adhering to this structure is essential for ensuring your submission is complete and review-ready.
CSRs can be hundreds of pages long and require the integration of complex data from multiple sources. Common challenges include:
These challenges make it essential to work with experienced medical writers who understand regulatory expectations and have the skill to communicate your study's story with clarity and precision.
GLOBAL’s regulatory writing team provides expert support for end-to-end CSR development. Whether you're preparing for a US FDA or EU submission, we help you meet ICH E3 requirements and tell a clear, compelling clinical story. Our services include:
A well-written CSR does more than document your trial—it builds trust with regulators. Our team of senior writers brings experience across therapeutic areas, trial phases, and global submissions. We help you reduce review cycles, improve quality, and stay on timeline.
Let us help you turn your trial results into a submission-ready report that speaks with clarity, accuracy, and confidence.
Contact us today to learn how our clinical writing team can accelerate your CSR development.
For sponsors developing new therapies, one of the most critical milestones on the regulatory pathway is preparing and submitting a New Drug Application (NDA). While biologics require a Biologics License Application (BLA), small-molecule drugs follow the NDA process.
The BLA is more than just an administrative step. It is the culmination of years of research, development, manufacturing, and clinical testing, and it represents the sponsor’s formal request that the FDA approve a biologic for commercial distribution in the United States.
Whether you’re submitting to the FDA, EMA, or another authority, the CSR must tell a clear, compliant, and credible story of your trial. GLOBAL's Medical Writing team shares tips and tricks to get it right.
