Navigating the complexities of clinical trial data and regulatory submissions can be challenging. Ensuring compliance with Clinical Data Interchange Standards Consortium (CDISC) standards and integrating the latest innovations like the CDISC Open Rules project is crucial for success. We offer tailored consultancy services to help you achieve these goals efficiently and effectively. Our expertise in CDISC standards, combined with our pioneering involvement in CDISC Open Rules, ensures your data is submission-ready, compliant and optimized for regulatory success.
Expedite your clinical trial submissions with our expert CDISC consultancy services, ensuring your datasets meet all necessary standards.
Rely on our expertise to meet the strict data standards required by global regulatory bodies such as the FDA, EMA, MHRA and PMDA.
As an official CDISC Registered Solutions Provider (RSP) our team of experts provides in-depth knowledge and support for implementing Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards.
We support you with a variety of flexible legacy data services, the development of CDISC implementation guides (IG) for SDTM, ADaM, Define.xml and metadata repository creation and maintenance.
Leverage our pioneering expertise in the CDISC Open Rules project to integrate cutting-edge data conformance rules, enhancing your data quality and compliance.
Customize your data conformance processes with our flexible solutions, including bespoke rule packages and in-house CDISC Open Rules implementation.
Automate and streamline your data validation processes with CDISC data conformance rules, saving time and resources.
CDISC Open Rules includes open-source software developed by CDISC that implements executable data conformance rules from the Foundational Standards, enabling industry-wide validation of data packages in line with CDISC and regulatory requirements. At SGS, we believe CDISC Open Rules is revolutionizing clinical research by enhancing quality assurance, compliance, efficiency and interoperability.
Our CDISC Open Rules consultancy services guide you through every step of the implementation process:
Choose the right package for your CDISC Open Rules implementation

We are recognized as the benchmark for quality and integrity in clinical trials. Our experts have successfully supported multiple clinical trial submissions to global authorities. Our unmatched expertise in CDISC standards and our leadership role in the CDISC Open Rules project position us at the forefront of industry advancements. As the global leader in inspection, certification and testing, our team of CDISC Open Rules experts and authorized CDISC Open Rules training facilitator bring unparalleled knowledge and experience to every project. Our commitment to quality, integrity and innovation, bolstered by our CDISC, SDTM, define.xml and ADaM certifications, ensures that your data management processes are compliant, efficient and ready for regulatory submission.
Our services include comprehensive support, from initial consultations and strategic planning to full project execution and ongoing evaluation. With SGS, you can trust that your clinical trial data will meet the highest standards of quality and compliance.