New service aims to revolutionise clinical trial data submissions
SGS, the global testing and certification organisation, has unveiled a specialised consultancy service focused on transforming the complex process of clinical trial data submissions. The CDISC Open Rules Consultancy aims to address the increasingly intricate requirements of regulatory compliance in clinical research.
Technical expertise meets regulatory demands
The service emerges at a crucial time when pharmaceutical organisations worldwide wrestle with the complexities of Clinical Data Interchange Standards Consortium (CDISC) compliance. As an official CDISC Registered Solutions Provider (RSP), SGS brings substantial expertise to the implementation of CDISC Open Rules, a critical component in standardising industry-wide validation of clinical data packages.
The initiative is spearheaded by Roman Radelicki, Head of Data Technology, working alongside Data Management System and Process Managers Marisa Wyckmans and Els Janssens. Notably, Janssens has achieved recognition as the first authorised CDISC training facilitator for CDISC Open Rules, underscoring the team’s technical prowess.
Commenting on the development, Radelicki 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.”
Technical implementation and integration
The consultancy’s approach encompasses comprehensive support for pharmaceutical organisations, from initial strategic planning through to full implementation. Key technical features include:
• Integration with the CDISC Library’s application programming interfaces (APIs)
• Implementation of the CDISC Open Rules Engine (CORE) with command line interface capabilities
• Automated conformance checking using executable rules
• Customisation options for company-specific requirements
Clinical data management implications
For clinical research organisations, the implementation of CDISC Open Rules presents several advantages in data management:
1. Enhanced quality assurance protocols, reducing submission failures
2. Streamlined compliance with regulatory requirements
3. Improved interoperability between clinical data systems
4. Resource optimisation through automated conformance checks
5. Flexibility in implementing organisation-specific rules
The service aligns with requirements from major regulatory bodies, including the FDA, EMA, MHRA and PMDA, ensuring that clinical trial data meets the necessary standards for submission. This comprehensive approach to data management reflects the increasing complexity of clinical trial submissions and the need for standardised, efficient processes in modern pharmaceutical research.
The biometrics team at SGS maintains strict adherence to ICH-GCP guidelines while implementing these new protocols, ensuring that data packages are fully aligned with current regulatory standards. This systematic approach to clinical data management represents a significant step forward in streamlining the submission process for clinical trials, potentially reducing time-to-market for new therapeutic interventions.
