Overview

The Clinical Study Report (CSR) is an “integrated” document of an individual study mainly aimed at the efficacy and safety of medicinal products. It includes results of the clinical trials compiled in a summarized academic general paper, as a Clinical Study Report. The CSR Report 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 investigations 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 Reports is specialized 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. 

 

Freyr Expertise

  • CSR publishing by conducting RLP activities as per the HA specifications and recommendations within the specified timelines
  • Proactive RLP within a short time
  • Multilevel QC review post the RLP-activity for CSR reports
 

Freyr Advantages

  • 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
 

Freyr SUBMIT PRO

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:

www.ectdtool.com