The Clinical Data Interchange Standards Consortium (CDISC) is an open, international, non-profit organization that develops global standards and innovations for working with clinical trials data throughout all stages of the study from protocol (Protocol Representation Model) to the final analysis (Analysis Data Model). The CDISC mission is to implement in everyday the practice of the standards of the industry professionals, which will provide effective clinical trial conducting, and its high quality.
Despite the fact that Data MATRIX became a CDISC member only in 2017, our team strictly followed its standards regarding data management, statistical analysis and medical documentation since the very beginning. CDISC approach provides Data MATRIX projects with high data quality, which ensures successful data acceptance by all foreign regulatory authorities (FDA, EMA). Implementing these standards optimizes the work of the company’s business units and decreases resources needed by 70-90% at the start-up stage and by 60% in terms of the whole project.
Data MATRIX team considers a traceability of the data and the results based on it as one of the most important feature of the projects conducted in accordance with CDISC. It eliminates the possibility of fraud, minimizes the risk of mistakes, which makes everything transparent, particularly for the regulatory authorities. The transparency of Open data for all of the industry participants became the main trend for clinical trials in the last few years. It gained traction from the FDA and the EMA.
Another big value for CDISC is the educational possibilities and sharing experience among partners. The Consortium regularly hosts conferences, meetings and webinars, dedicated to the topical issues of data management in clinical trials.
Data MATRIX is proud to be an active CDISC member!
