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.
Receive support across all types of the CSRs as per your study requirements
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.
Along with the CSR body, we develop the synopsis of the CSR, allowing you to convey your study's objectives, methodology, and results effectively.
When speed is of the essence, we specialize in producing concise, yet highly informative synoptic CSRs to meet your timelines.
We craft abbreviated CSRs without compromising on content quality, delivering streamlined documents suitable for fast-track submissions.
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.
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.