CSR - Report Level Publishing

Freyr's expert team offers end-to-end support for Clinical Study Report (CSR) submissions, specializing in Document Level Publishing (DLP) and Report Level Publishing (RLP) to ensure compliance with regulatory requirements.

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CSR - Report Level Publishing - 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 trial reports compiled in a summarized academic general paper as a Clinical Study Report submission. 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 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 Reports specialises 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.

CSR - 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 short time.
  • Multilevel QC review posts 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.

Accurately Present Your Clinical Trial Data with Report Level Publishing (RLP)

Partnering with Leading Organizations

 

Medicinal Products

Publishing and Submission

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Michael Bellero

Sr. Director, Head of Regulatory Operations

 

Medicinal Products

Publishing and Submission

UK

We would like to appreciate Freyr’s quick TAT to push through an urgent submission required by the FDA. Their efficiency, diligence, excellence, sense of urgency, and priority are deeply flexibility.

Please keep up the great work as we have many milestones to achieve over the next year.

Ed Venkat

Global CMC Technical Lead

 

Medical Devices

Publishing and Submission​

USA

Communication and on the ground knowledge or RA requirements - this has been our experience for India. Quick to response and willing to have calls to explain requirements. Very happy with the RA work conducted in India, would use for other markets. We are satisfied. ​

Director of Regulatory Affairs​

France-based, Leading Global Supplier of Women Healthcare Products Company​