CDISC-based Implementations Receive Sanofi’s Global R&D IS Innovation Awards: Internal Business Value and Value to Patients

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Clinical Data Interchange Standards Consortium (CDISC) standards were at the core of two recent Global R&D IS Innovation Awards at Genzyme/Sanofi. Out of 208 dossiers submitted, GetSMART (which involved implementation of a number of CDISC standards) won in the ‘Internal Business Value’ category. RegistryNXT! (which is based on the collaborative BRIDG model) won in the ‘Value to Patients’ category. Criteria for evaluation of the dossiers included: Competitiveness and Value Creation, Opportunities, Breakthrough and Creativity, Simple and Clever, Innovation Behavior, Collaboration with Different Entities/Breaking Silos and a bonus criterion of Sustainability/Green Value.

Clinical Data Interchange Standards Consortium (CDISC) standards were at the core of two recent Global R&D IS Innovation Awards at Genzyme/Sanofi. Out of 208 dossiers submitted, GetSMART (which involved implementation of a number of CDISC standards) won in the ‘Internal Business Value’ category. RegistryNXT! (which is based on the collaborative BRIDG model) won in the ‘Value to Patients’ category. Criteria for evaluation of the dossiers included: Competitiveness and Value Creation, Opportunities, Breakthrough and Creativity, Simple and Clever, Innovation Behavior, Collaboration with Different Entities/Breaking Silos and a bonus criterion of Sustainability/Green Value.

PK Tandon, Clinical Science Officer, Clinical Development, and an Executive Sponsor of both the GetSMART and RegistryNXT! Programs at Genzyme stated “We are very pleased to have received these awards and even more pleased to see the beginnings of adoption in parts of the broader Sanofi organization. This was truly a team effort with input from various stakeholders. We live in an increasingly complex clinical data environment. CDISC standards have helped to streamline our information handling processes, facilitated exchange with external parties, and improved our ability to create integrated datasets to speed answers to regulatory and scientific questions.”

“We are delighted to congratulate the Genzyme teams for their extraordinary work in earning these awards,” stated Rebecca Kush, President and CEO, CDISC. “Both GetSMART and RegistryNXT! are stellar examples of how to gain the most value from CDISC standards---building them into the process from the start and beginning with the end in mind. It is very gratifying to see how CDISC standards can be applied so effectively to provide real business value within the clinical research industry as well as value for patients.”

GetSMART achieves efficiency by combining global business process and technology with standards by consistently defining information to facilitate data reuse and exchange with internal and external partners, to streamline business processes, and to meet current and likely future regulatory guidelines and mandates. GetSMART was successfully implemented at Genzyme and is viewed as a model for parts of the Sanofi R&D organization. Genzyme was able to simplify business processes and increase return on investment through the use of several CDISC standard solutions:

  •     CDISC CDASH and the CDISC Lab Model for streamlining data collection and database development, enabling data processing efficiencies and improving communication, data exchange and coordination of activities between Genzyme and partners such as CROs, Central Labs, and EDC vendors;
  •     Incorporating CDISC data submission standards (SDTM) into CDASH case report forms (CRFs) minimizes and automates the transformations required to produce submission data sets and allows reuse of CDISC standard analysis dataset model (ADaM) datasets;
  •     Development of a Metadata Repository (MDR), as part of Sanofi’s MAESTRO program, will provide an essential foundation for achieving the vision of a metadata-driven clinical data lifecycle by facilitating the definition, use, maintenance and governance of Genzyme’s clinical information standards.

RegistryNXT! is a state-of-the-art, standards-based, data collection and near real-time reporting platform for a Global Patient Registry. The platform, which has won the award for value to patients, enables observational studies to collect uniform data, and analyze specified outcomes, for patients with a particular disease or condition. RegistryNXT! improves and optimizes the quality of care for patients worldwide through the publication of registry data and evidence-based disease management recommendations; supports the evaluation of long-term treatment effectiveness; supports post marketing commitments regarding long term patient safety, as well as reimbursement, market access and product label expansions. RegistryNXT! is based upon the Biomedical Research Integrated Domain Group (BRIDG) model, which is a collaborative domain analysis model developed and governed by CDISC, HL7, NCI and FDA, with a scope of protocol-driven research and patient safety. The platform has already implemented a registry for Gaucher Disease, and is being adopted on new registries for Fabry and Pompe diseases---all on the same standards base.

Sue Dubman, head of Genzyme’s Standards and Architecture Team at the time and now in Sanofi’s R&D IS organization, stated that “the key secrets to success in both GetSMART and RegistryNXT! were active involvement by the business and treating and understanding that both programs involved significant organizational and business process change. We implemented standards in new ways to get new results”.

ABOUT CDISC
CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

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Diana Harakeh
CDISC
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