The FDA Group's CEO Nick Capman, sits down with Sunil Gupta, a seasoned expert in pharmaceutical data, to shed light on the nuances of SDTM (Study Data Tabulation Model) compliance and its pivotal role in clinical trial processes.
Sunil brings a wealth of experience from his three decades in the pharmaceutical industry, focusing on areas like SAS programming, submissions, and leveraging new technologies for clinical trials.
Discussion points include:
» The transition from manual processes to technology-enhanced procedures in clinical trials — specifically the shift towards automation and standardization.
» An in-depth look at SDTM compliance, its critical importance in FDA submissions, and the need for uniform data standardization.
» The many challenges associated with ensuring compliance in clinical data management, including those related to documentation, security, and proactive monitoring.
» Navigating the common pitfalls in SDTM compliance, such as misinterpretations in compliance reports and the importance of granular data verification.
» Sunil’s recommended resources for mastering compliance, including websites like cdisc.org and phuse.global, and the value of attending relevant webinars and workshops.
» Predictions for the future of clinical data tools and applications, and the growing integration of compliance tools in the SDTM generation process.
» The crucial role of collaboration and resource utilization in achieving effective SDTM compliance. Sunil shares his involvement in mentoring and open-source initiatives.
» The importance of automation, technology, and standardization in enhancing the quality and efficacy of clinical trial data.
Sunil Gupta is an expert in CDISC and SAS programming, offering specialized teaching and mentoring services. He emphasizes real-world examples and utilizes a CDISC reference file to ensure compliance with CDISC and FDA guidelines.
Sunil is also the founder of SASSavvy.com, a pioneering SAS® Blog membership subscription service. This platform simplifies the search and application process for SAS® programming challenges.
Sunil's extensive experience in the pharmaceutical and medical device industries has proven his skills as a hands-on CDISC/SAS programmer and project lead. His unique methods have resulted in substantial time and cost savings, demonstrating his exceptional ability to innovate in the field of CDISC and SAS programming.
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