Showing posts tagged with “CDISC”

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  • CDISC standards in clinical trials are the cornerstone of any successful submission to regulatory agencies. While they are “standards,” the structure and the nuances of applying them are continually evolving and changing, making it important to keep up to date in order to provide quality submissions. Here at PROMETRIKA, a full-service CRO, our statistical programmers and biostatisticians engage in continuing education activities by attending webinars, conferences, and training sessions specifically related to CDISC standards in clinical trials.

  • I had the opportunity to attend the 2023 PHUSE conference and explore the latest advancements in clinical data analysis through engaging workshops and presentations. Key topics included CDISC Analysis Results Standards, SDTM mapping recommendation engines, incremental automation using machine learning, and Leadership and professional development. The conference provided valuable insights into emerging trends and technologies that are shaping the future of clinical research.

  • In any industry, there are various methods for approaching task deadlines to remain within the timeline. It is vital to choose a method that can accommodate challenges faced during the project and reduce time or at least help mitigate any delays. Effective task management is the key to maintaining the project budget and addressing other challenges.

  • I can actually say that I have been working in the Clinical Trials industry since the last century.  I started as a database programmer, part of data management in a large (now huge) CRO.  In those days we used paper CRFs, entered by hand into a database platform that was built and maintained inhouse.  We had our own naming conventions for variables and could pretty much build whatever we wanted and group the data however it made sense to us.  Prior to deliverables, we printed out the entire database so data managers could review it. All the files were burned to floppy discs and we’d pop them in the mail to the sponsor.  With the amount of data we collect, and the requirement to do more, faster, can you even imagine doing that now?

  • Last October, Susan Boquist, Associate Director, Statistical Programming, traveled to CDISC International Interchange in San Diego, California to present the poster, “Creating Harmonious SDTM Domains”.  The poster was created in collaboration with Principal Statistical Programmers: Elena Prosekova, Natalia Quinn and Sofia Tyryshkina. 

    Mapping raw data into standardized, tabulated data sets can be a daunting task to undertake, especially if one has not done it before.  Even seasoned mappers could use the help of some additional ideas and tips.  The poster shared the authors’ thoughts, suggestions and examples to help turn a cacophony of raw data into a standardized symphony that will flow into analysis.