CDISC Open Rules Consultancy Services Launches

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 Chief 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 leading role as a key contributor and early adopter of this critical initiative.”

Roman Radelicki, Head of Data Technology, said: “CDISC Open Rules are a major change for the industry, defining the future of data conformance. With SGS by your side, you can be certain your journey towards their implementation will be smooth and stress-free.”

Our CDISC Open Rules consultancy services guide companies through every step of implementation from initial consultation and strategic planning to full project execution and ongoing evaluation.

The benefits of implementing CDISC Open Rules within your organization include:

• Quality assurance: ensuring consistently high-quality data is ready for submission, reducing the risk of errors, time-consuming corrections and submission failures
• Compliance: helping with adherence to industry standards, regulatory requirements, and company-specific rules, thereby minimizing the risk of non-compliance
• Interoperability: the CDISC Library offers a comprehensive set of application programming interfaces (APIs) for accessing the CDISC Conformance Rules and the CDISC Open Rules Engine (CORE) offers a command line interface (CLI)/API, facilitating seamless integration with existing clinical data systems; as well as supporting the creation of local rules to enable their exchange between stakeholders
• Efficiency: via automated data conformance checks using CDISC's executable conformance rules and open-source execution engine to save time and resources
• Flexibility and adaptability: in-house implementation of the CDISC Open Rules Engine enables customization for the incorporation of company-defined rules and the ability to add further requirements

About SGS clinical research

Our biometrics team is committed to ensuring all necessary trial data is captured, reviewed, and analyzed to the highest standards. We focus on maintaining high-quality data, meticulously adhering to rules set by ICH-GCP, CDISC and regulatory agencies like the FDA, EMA, MHRA and PMDA, to guarantee all global requirements are met. Our data packages are fully aligned with the latest data standards, ensuring clinical trial data is ready for regulatory submissions. When you need to be sure, choose SGS.

For further information, please contact:

Els Janssens
Data Management System and Process Manager
Health Science, SGS
t: +32 (0)35 45 44 99