Clinical Study Report Medical Writing

What is Clinical Study Report?

Clinical study report (CSR) is a document that elaborates the study design, method, participating subjects, results and other important information for the submission to regulatory authorities. CSR will have tables, figures, listings, and appendices that complements the overall report. CSR submissions is a key part of the overall drug approval process.

Types of Clinical Study Report

Choosing the right CSR type is important to support the overall objective of the sponsor.

1. Full CSR

A full CSR is required to obtain approval by the regulatory agency. Full CSR has the complete clinical and statistical details of the study conduct as well as the full safety, efficacy and PK/PD data.

2. Abbreviated CSR

A shorter and more condensed version of full CSR, the purpose is to focus on safety aspects of the study. It usually contains abbreviated methods and efficacy sections, and a comprehensive safety information.

3. Synoptic CSR

Synoptic clinical study report still focuses on safety, being used mainly in studies which are not relevant to efficacy or clinical pharmacology.

4. Interim CSR

Interim CSR refers to a comprehensive but usually shorter CSR created during the running of the clinical study trial. The purpose can be to provide an overview of the progress to the target audience.

5. Supplemental CSR

Supplemental CSR provides additional or supporting data to support the full CSR.

Obatica’s Medical Writing Services:

Obatica medical writing team is experienced in writing clinical study report (CSR). B ook in for your free consult here to learn more about our medical writing services

Protocol review, writing and development (full protocol development)
Participant information consent sheet/form (ICF)
Investigator’s Brochure creation
Clinical study reports creation
Medical writing for abstract and manuscript
Support and assistance with conference/journal submission

What customer says about Obatica’s Medical Writing Services

Obatica recently performed two medical writing projects for a clinical-stage Biotechnology company. The client has a very ambitious timeline which Obatica is able to handle it nicely. Here is what our client has to say.

“Obatica is one of the best medical writers that we have worked with. We were impressed not only by the high quality of their work but also their ability to deliver the protocols under very ambitious timelines, customer-orientated attitude and overall value. We look forward to working with Obatica again on our future medical writing projects.”