Clinical Study Report Submission - Report-Level Publishing - Overview
The Clinical Study Report (CSR) is an integrated document of an individual study aimed at the efficacy and safety of medicinal products. It includes results of the clinical trial reports compiled in a summarized academic general paper as a Clinical Study Report submission. The CSR is a detailed report incorporating tables and figures into the main text or at the end of the text and with appendices containing the protocol, sample case report forms, investigator-related information, and information related to the test drugs/investigational products, including active control/comparators, technical statistic documentation, and details such as derivations, computations, analyses, and computer output, etc.
Under 21 CFR 314.50, the information on clinical investigation reports required should be submitted in one of the following three (03) formats:
- Full study report (Complete E3 report)
- Abbreviated reports
- Synopses
Freyr’s dedicated publishing and submission team for CSR submission specializes both in Document Level Publishing (DLP) and Report-level Publishing (RLP) and assists organizations with end-to-end CSR Report-level Publishing and Clinical Study Report (CSR) submissions.
Clinical Study Report Submission - Report-Level Publishing
- Publishing CSR by conducting RLP activities according to the Health Authority (HA) specifications and recommendations within the specified timelines
- Proactive RLP within a brief time
- Multilevel QC review post the RLP activity for Clinical Study Report (CSR) submissions
- 100% confidentiality of client information in a Clinical Study Report
- Fast-track support for requests
- Designated SPOC for updating training documents and special training on new Regulatory changes
- Identifying and defining delivery plans to handle last-minute updates on Clinical Study Reports.
