A Clinical Study Report (CSR) is an “integrated” report of an individual study mainly aimed at efficacy and safety of a medicinal product. It includes results of the clinical trials compiled in a simple academic general paper. The CSR conducted upon human beings is a detailed report, incorporating tables and figures either in the main text of the report or at the end of the text. Also, it contains appendices containing the protocol, sample case report forms, investigator related information, details 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 investigations required should be submitted in one of the following three formats:
- Full study report (Complete E3 report)
- Abbreviated reports
Freyr’s dedicated publishing and submission team is specialized both in document level publishing (DLP) and report level publishing (RLP), and assists organizations with end-to-end publishing and Clinical Study Report (CSR) submissions.
- CSR Publishing by conducting Report Level Publishing (RLP) activities as per Health Authority (HA) specifications and recommendations within specified timelines
- Proactive Report Level Publishing (RLP) within short time
- Multi-level QC review post RLP activity
- 100% Confidentiality of client information
- 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
For faster, compliant and seamless submissions, Freyr offers an in-house eCTD tool Freyr SUBMIT PRO. Freyr SUBMIT PRO suits all your submission requirements across the globe and supports regional formats. To know more about Freyr SUBMIT PRO, gain a comprehensive overview at: