Date: March 29, 2019
Contributed by: Matt Johnson, Data Analytics Team Lead at DF/Net
One of DF/Net’s great strengths is our ability to adapt. While this is typically in response to a specific study need or a Sponsor request, over the last few years we have been adapting to a larger shift in the industry. This shift has been to meet the FDA study standardization and transparency requirements as developed by CDISC.
While each study has a unique purpose, all studies have overlapping areas with regards to collected data, data purpose and need for traceability. CDISC has been leveraging these similarities to guide creation of models for data collection and database structures. CDASH guides data collection in a similar way across studies, SDTM guides the organization and formatting of a standardized clinical database and ADaM guides the organization and formatting of the analysis datasets.
As an adaptable software, our DFdiscover has been a great tool in making the necessary changes to implement the new and updating standards. Furthermore, our clinical staff of Data Managers, Data Coordinators, Statistical Programmers and Biostatisticians has adapted to these standards through training and experience. It’s a testament to our ability that Data Managers and Data Coordinators are already running studies in many different therapeutic areas following the CDASH model. And our Statistical Programmers are already experienced in creating SDTM domains and Biostatisticians in creating ADaM datasets. As this shift occurs, our clinical staff’s integration with the software team created a cascading effect on efficiencies using the software and developing databases. Among others, this has led to the creation in DFdiscover of a CDASH library of field names and properties, and utilization of export by modules to aid SDTM domain creation. We look forward to the expanding integration of standardization in our company and the benefits this will provide our clients and their studies.