SGS has launched a novel consultancy service designed to accelerate clinical trial submissions.
The CDISC Open Rules Consultancy allows companies to adhere to standards set out by the clinical data interchange standards consortium, as well as any necessary regulatory requirements.
As an official CDISC-registered solutions provider and a contributor to the CDISC Open Rules open-source software project, SGS holds significant expertise, and will be aware of any industry advancements that may occur.
The consultancy team will be led by SGS' Head of Data Technology, Roman Radelicki, who will be joined by Process Managers Marisa Wyckmans and Els Janssens.
Notably, Els was the first authorised CDISC training facilitator for CDISC Open Rules.
The team also have SDTM, define.xml and ADaM certifications, allowing companies to ensure that their data management and statistical testing protocols are compliant, efficient and suitable for regulatory submission.
According to SGS, the benefits of implementing CDISC Open Rules include:
- Quality assurance
- Compliance
- Interoperability
- Efficiency
- Flexibility and adaptability
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.”
SGS's CDISC Open Rules Consultancy services guide users through every step of implementation — from initial consultation and strategic planning to full project execution and evaluation.