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 Engine (CORE) 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 CORE, ensures your data is submission-ready, compliant and optimized for regulatory success.
Ensure your clinical trial data is compliant and submission-ready
- Achieve CDISC compliance
Expedite your clinical trial submissions with our expert CDISC consultancy services, ensuring your datasets meet all necessary standards.
- Ensure global regulatory compliance
Rely on our expertise to meet the strict data standards required by global regulatory bodies such as the FDA, EMA, MHRA and PMDA.
- Gain expert guidance on SDTM and ADaM standards
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.
- Get legacy data support
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.
- Adopt CORE with confidence
Leverage our pioneering expertise in the CDISC CORE project to integrate cutting-edge data conformance rules, enhancing your data quality and compliance.
- Tailor your clinical data
Customize your data conformance processes with our flexible solutions, including bespoke rule packages and in-house CORE implementation.
- Enhance efficiency
Automate and streamline your data validation processes with CORE’s executable rules, saving time and resources.
Your roadmap to Conformance Rules adoption
CORE is 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 CORE is revolutionizing clinical research by enhancing quality assurance, compliance, efficiency and interoperability.
Our CORE Conformance Rules consultancy services guide you through every step of CORE implementation:
- Initial consultation: begin your CORE journey with a detailed needs assessment, mapping out your current processes and goals
- Strategic planning: our CORE experts conduct a gap analysis and develop a customized plan to integrate CORE seamlessly into your operations
- Project scope: we present a strategic plan, including timelines, scope, and budget, tailored to your specific needs
- Project execution: we implement the CORE project with precision, ensuring your data meets all required standards
- Evaluation: ongoing assessments ensure the project stays on track and adapts to any changes in your needs or industry developments
Choose the right package for your CORE conformance rules implementation
- SGS-led project: our experts lead the CORE implementation, delivering validated conformance rules
- Hybrid project: collaborate with us as we co-manage the CORE implementation, ensuring comprehensive coverage
- Client-led project: take charge of the project with our support as needed, depending on your specific requirements
- Expert consultancy: receive guidance from our experts as you navigate CORE implementation challenges
CORE experts – officially recognized by CDISC
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 CORE project position us at the forefront of industry advancements. As the global leader in inspection, certification and testing, our team of CDISC CORE experts and authorized CDISC CORE instructor 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.