Overview

Clinical Study Report (CSR) is an “integrated” report of an individual product/drug aimed at efficacy and safety. It includes results of the clinical trials compiled in a brief and academic general paper. The CSR is a detailed report incorporating tables and figures into the main text or at the end of the text, with appendices containing the protocol, sample case report forms, investigator related information, information related to the test drugs/investigational products, including active control/comparators, technical statistic documentation, and data such as derivations, computations, analyses, and computer output, etc.

Under 21 CFR 314.50, the applicant should submit the required information on clinical investigations in one (01) of the following three (03) formats:

  • Full Study Report (Complete E3 report)
  • Abbreviated Reports
  • Synopsis

Freyr’s dedicated publishing and submission team is specialized in Document Level Publishing (DLP) and Report Level Publishing (RLP) and assists organizations with end-to-end publishing and CSR submissions.  

 

 

Freyr Expertise

  • CSR Publishing by conducting RLP activities as per Health Authority (HA) specifications and recommendations within specified timelines
  • Proactive RLP within a short time
  • Multilevel QC review post the RLP activity
 

Freyr Advantages

  • 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
 

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