Overview

The Clinical Study Report (CSR) is an “integrated” report of an individual study mainly aimed at efficacy and safety. It includes results of the clinical trials compiled in a briefer academic general paper. The CSR conducted upon human beings is a detailed report, incorporating tables and figures into the main text of the report or at the end of the text, and 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 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 reports (Complete E3 report)
  • Abbreviated reports
  • Synopses

Freyr’s team of dedicated publishing team experts, who possess the requisite knowledge and expertise of all these formats, assists organizations with end-to-end publishing and CSR submissions.  Freyr’s CSR capabilities include:

 

Freyr Expertise

  • Publishing of CSR by conducting RLP activities as per Health Authority (HA) specifications and recommendations within specified timelines
  • Being proactively involved in providing RLP within short time
  • Thorough or multilevel QC review after RLP activity
 

Freyr Advantages

  • Confidentiality of client information
  • Supports fast track requests
  • Designated SPOC identified for updating training documents and training provided for new Regulatory changes to team
  • Identifying and defining delivery plans to handle last minute updates.