About this role
What are you looking for? CDISC Open Rules Consultancy Services Launches Clinical Research News October 21, 2024 We are delighted to announce the launch of our CDISC Open Rules consultancy, a brand-new service to help pharmaceutical organizations around the globe transform and accelerate their clinical trial submissions. Achieving compliance with the latest Clinical Data Interchange Standards Consortium (CDISC) standards and regulatory requirements can be challenging. Our experts are here to help companies navigate the new CDISC Open Rules. As contributors to the project since day one, we are ready to help the industry adopt the new standards. As an official CDISC Registered Solutions Provider (RSP) and trusted advisor, with a leadership role in the CDISC Open Rules open-source software project, we have gained unmatched expertise at the forefront of industry advancements. We recognize how the implementation of CDISC Open Rules has the power to revolutionize clinical research by enabling industry-wide standardized validation of data packages. We are trusted partners of CDISC. Our consultancy team, led by Roman Radelicki, Head of Data Technology, and Data Management System and Process Managers, Marisa Wyckmans and Els Janssens, played a key role in the development of the first CDISC Open Rules. Alongside a growing team of specialists, they provide extensive knowledge and experience, bolstered by CDISC, SDTM, define.xml and ADaM certifications, to ensure that data management and statistical processes are compliant, efficient, and ready for regulatory submission. Els Janssens is also the first CDISC authorized training facilitator for CDISC Open Rules. Peter Van Reusel, CDISC Standards Officer commented, "CDISC is now offering the CDISC Open Rules in a machine-executable format alongside its standards, emphasizing our commitment to supporting interoperability and innovation in the industry. It's exciting to see SGS taking a lead...