You rely on clinical data to gain regulatory approval. You may need to adhere to CDISC standards for your clinical data to be accepted by regulatory agencies, such as the FDA. CDISC streamlines the regulatory process by reducing the risk of regulatory issues and allowing you move through the regulatory process more efficiently.

Besides regulatory requirements, there are several advantages to using CDISC. Usage of SDTM, the CDISC Study Data Tabulation Model, ensures data consistency and portability. ADaM, Analysis Data Model, datasets are designed to be analysis-ready, formatted and organized in a way that is optimized for statistical analysis. This streamlines the statistical analysis process, reducing the time and effort required to generate results and ensuring quality of results.

But generating CDISC-compliant datasets is a complex, demanding, and time-consuming process that requires significant expertise and attention to detail. It requires a deep understanding of CDISC standards and guidelines and the use of specialized software tools to ensure that datasets are accurate, consistent, and fully compliant.

Our expert team at Agilis specializes in providing high-quality, accurate CDISC datasets for clinical trials. We have experience gained through creating datasets for several successful regulatory submissions of demanding clinical studies.

We use the latest tools and technologies to ensure that our datasets are fully compliant with standards and regulatory requirements and we deliver by applying strict QA procedures for testing and data verification.

And we have developed our own generic CDISC software tools. Our proprietary CDISC Generator (which is also integrated in our EDC solution) allows us to transform your clinical data into SDTM format with no or minimal programming. Our CDISC experts can focus on the semantic mappings between your clinical data and CDISC structures and controlled terminologies, and leave the actual transformation of the data to be done automatically by a tested and validated software.

This allows quick iterations if changes are required and allows us to create CDISC datasets in less time and with less cost than with typical programming. Most importantly, it minimises the risk of human error.

And of course we can do the analysis based on the ADAM datasets and provide you the TFLs and the Statistical Study Report following ICH E3 guidelines. Our tools, coupled with our know-how, allow us to work quickly and efficiently to deliver your high quality CDISC datasets and analysis on time and on budget.

Contact us today to learn more.