,Clinical Study Report (CSR) Submission - Overview
A Clinical Study Report (CSR) Submission is a comprehensive document that communicates the design, methodology, results, and conclusions of a clinical trial. It supports regulatory agencies in assessing the efficacy and safety of a medicinal product. A well-prepared Clinical Study Report (CSR) Submission includes detailed appendices such as protocols, sample case report forms, clinical reports, investigator details, and information about investigational products, including comparators and statistical outputs.
As per 21 CFR 314.50, CSR in clinical trials should be submitted in one of the following formats:
- Full study report (Complete E3 report)
- Abbreviated reports
- Synopses
Freyr offers end-to-end CSR Submission Services, including:
- Scanning and converting documents to PDF
- Creating bookmarks and hyperlinked tables of contents
- Linking clinical study reports to appendices
- Quality control for navigation and pagination
- Custom headers and footers to ensure formatting compliance
Our publishing experts specialize in both Document Level Publishing (DLP) and Report-Level Publishing (RLP), offering tailored support for every CSR clinical study need. Whether it’s a standalone CSR pharma submission or part of a broader regulatory application, our services ensure your submission is accurate and ready for agency review.
Clinical Study Report Submission - Report-Level Publishing
- Conducting RLP for Clinical Study Report (CSR) submissions per Health Authority (HA) specifications
- Fast turnaround for high-priority submissions
- Multilevel QC reviews to ensure data integrity
- 100% confidentiality of client data in every clinical study report
- Fast-track support and dedicated SPOCs
- Regular training on evolving global regulatory changes
- Agile delivery to handle last-minute updates in (CSR) clinical study reports
With Freyr’s reliable CSR Submission Services, organizations gain a strategic edge in global compliance and submission efficiency.
