At Narrativa, one of our main focuses is the acceleration of the clinical documentation process for drug trials and treatments. To achieve this, new submissions must be sent to regulatory authorities such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe. The submissions are data-intensive and deeply summarize clinical trials, so the quality standards for data must be extremely high. Not only do we work to meet these, but strive to exceed them. This is why today we are happy to announce that we are elevating standards: Narrativa is now a CDISC Member.

What is CDISC?

CDISC, or Clinical Data Interchange Standards Consortium, is an organization that creates standards for organizing and sharing clinical trial data. In simple terms, CDISC helps ensure that data from different clinical studies are structured in a consistent way. This makes it easier for researchers, regulatory agencies, and others to analyze and understand data, ultimately improving the efficiency and quality of clinical trials.

Narrativa offers an AI-automated medical writing document service that quickly and accurately authors smart documentation such as smart CSRs (clinical study reports), smart patient narratives, smart TLFs (tables, listings, and figures), smart redacted/anonymized files and more. From database to delivery, we not only speed up the clinical trial process and reduce errors, but prepare completed documentation for medical writer review and subsequent submission to regulatory bodies—all without the need for your team to piece together parts of documents themselves.

That is why we are proud to be part of CDISC; data quality has been and will continue to be paramount to our success!

Working to amplify data’s impact

CDISC creates clarity in clinical research by bringing together a global community of experts to develop and advance data standards. Together, we all enable the accessibility, interoperability, and reusability of data for more meaningful and efficient research—all of which has a greater impact on global health.