CSR - Report-Level Publishing

Freyr's CSR-Report-Level Publishing ensures seamless submissions with full compliance to ICH E3 and electronic requirements. We handle Clinical Study Reports, Integrated Summaries of Safety and Efficacy, Investigator's Brochures, complex documents with appendices, and briefing packages. Services include scanning content, converting documents to PDF, creating bookmarks and hyperlinked tables of contents, linking reports to appendices, quality control on navigation, and overall pagination with customized headers and footers.

CSR - Report-Level Publishing - Overview

The Clinical Study Report (CSR) is an integrated document of an individual study 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 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 specializes 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 brief time
  • Multilevel QC review post 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)

Consult Freyr

Celebrating Customers Success

 

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

 

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

 

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​