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.
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 CDISC Open Rules with confidence
Leverage our pioneering expertise in the CDISC Open Rules 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 CDISC Open Rules implementation.
- Enhance efficiency
Automate and streamline your data validation processes with CDISC data conformance rules, saving time and resources.
Your roadmap to CDISC Open Rules adoption
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:
- Initial consultation: begin your CDISC Open Rules journey with a detailed needs assessment, mapping out your current processes and goals
- Strategic planning: our experts conduct a gap analysis and develop a customized plan to integrate CDISC Open Rules 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 CDISC Open Rules 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 CDISC Open Rules implementation
- SGS-led project: our experts lead the CDISC Open Rules implementation, delivering validated conformance rules
- Hybrid project: collaborate with us as we co-manage the CDISC Open Rules 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 CDISC Open Rules implementation challenges
CDISC Open Rules 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 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.
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