Poorly written Clinical Study Reports (CSRs) delay the overall clinical development of an Investigational Medicinal Product (IMP). Whereas a timely and well written CSR for every completed trial contributes to speeding up the overall clinical development process. This results in improved timelines in receiving successful marketing authorization (NDA/BLA/MAA) for the IMP.

At Quanticate, we understand that the timely development and submission of CSRs are vital steps in bringing your pharmaceutical or biotech product to market. Our dedicated team of seasoned medical writers is committed to delivering high-quality, compliant, and meticulously crafted CSRs tailored to your specific needs.

A CSR presents what was planned (as per the protocol), what changed and why, what was performed, and what was observed within a study. The study results are presented at different levels of detail such as text, in-text tables and figures, end-of-text tables and figures, subject narratives, data listings and additional summaries, selected completed Case Report Forms, and Case Report Tabulations (US Archival Listings) etc. Based on study complexity, the CSR (along with appendices) could vary in length.

CSR Writing Services

Receive support across all types of the CSRs as per your study requirements

Full CSR with Appendices and Publishing

Along with the full CSR writing (CSR body, Synopsis), we also perform the preparation of appendices (per ICH E3), publishing of the full CSR and provide you with the submission ready CSR package.

Full CSR

Along with the CSR body, we develop the synopsis of the CSR, allowing you to convey your study's objectives, methodology, and results effectively.

Synoptic CSR

When speed is of the essence, we specialize in producing concise, yet highly informative synoptic CSRs to meet your timelines.

Abbreviated CSR

We craft abbreviated CSRs without compromising on content quality, delivering streamlined documents suitable for fast-track submissions.

Supplemental (Addendum) CSR

Supplemental CSRs provide additional detail to a full study report. It may be required for a variety of reasons. This may include planned, but not primary, analyzes that were not completed in time to be included in the full CSR, unplanned exploratory analyzes, or cross-study analyzes.

Service Features

ICH E3 Compliant Template

We create CSRs that strictly adhere to the ICH E3 guidelines, ensuring your document meets global regulatory standards. However, we also follow client specific templates for CSRs, as required.

Writing of Shell CSR

If you just require the basic blueprint of your study report in place which you plan to complete at a future date, we can provide Shell CSRs.

Study Results and Drafting of CSR

Our expert medical writers excel at presenting complex clinical trial data coherently and accurately, providing a comprehensive view of results for your study endpoints.

Primary Endpoints

We meticulously detail your primary endpoints and outcome measures, presenting the most critical data accurately and comprehensively.

Secondary Endpoints

Our experts provide a thorough analysis of secondary endpoints focusing on results of key secondary outcome measures, highlighting the broader context of your study.

Exploratory Endpoints

We delve into the exploratory endpoints, offering insights into the potential implications of your study's findings. The results for the exploratory endpoints may not impact labelling yet be helpful for additional research or for developing new hypotheses.

Peer Review and Quality Checks (QC)

Our CSRs undergo rigorous peer review and quality checks to ensure they meet the highest standards of accuracy, clarity, and completeness.

Consistency and Accuracy

We maintain consistency between the synopsis and the CSR body, as well as among different sections of the CSR, to provide a seamless reading experience and to meet regulatory expectations.

Therapeutic Experience

Our team of regulatory medical writers have written CSRs across a wide range of therapeutic areas and indications, allowing us to handle diverse projects with expertise and precision.

Lean Writing

We specialize in lean writing techniques, ensuring that your CSR is concise and impactful, without unnecessary verbosity.

Meeting Style Guide Requirements

Our CSRs are crafted to meet your specific style guide requirements, maintaining your company's unique branding and messaging.

CSR Appendices

Our medical writers prepare, compile, and finalize required appendices per ICH E3 guideline and study specific requirements.

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CSR Publishing

We format and publish CSRs along with appendices and provide a submission-ready CSR package to you.

At Quanticate, we take pride in our ability to transform complex clinical data and statistical analysis outputs (TFLs) into well-structured, compliant, and highly informative CSRs. Our dedication to quality, regulatory compliance, and meeting your unique needs sets us apart as a trusted partner in your drug development journey.

Contact us today to learn more about our CSR writing services and how we can assist you in achieving your regulatory and marketing authorisation goals.

Clinical Study Report (CSR) Writing Services