Data Standards Consulting

Octagon’s Data Standards Consulting (DSC) Team offers clients expertise in data-submission standards such as the CDISC Study Data Tabulation Model (SDTM). The Data Standards Consulting team helps sponsors determine the best place to implement the SDTM, whether an EDC system, a clinical data management system, or a data warehouse. The team also recognizes that sometimes the most cost-efficient solution is dataset conversion at the end of a sponsor’s current clinical-data-flow process. The team has also provided review and feedback on sponsor’s and third-party data conversions, along with recommendations for streamlining existing processes.
 
The Data Standards Consulting team has had extensive involvement in the development of CDISC standards, with long-term membership on various CDISC teams. Members have been active on the CDISC Submission Data Standards (SDS) Team since its inception in 1999. The SDS Team has worked closely with FDA representatives, resulting in the team’s Study Data Tabulation Model (SDTM) becoming a Study Data Specification in the eCTD in 2004. Members have been active in numerous FDA pilot projects for the submission of clinical data. DSC members have also been involved with the CDISC SEND (Standard for the Exchange of Nonclinical Data, an implementation of the SDTM for toxicology and pharmacology data) Team since its inception in 2002. This team has also worked closely with the FDA, and is now involved in its second pilot project with the Agency.
 
The DSC team is also involved in the development of emerging HL7 standards, which are increasingly being adopted by the FDA.
 
Octagon has been a certified CDISC trainer for CDISC on the SDTM and its implementation guide for human clinical trials since 2005 and for SEND since 2006. DSC members have trained more than 2000 people in more than 10 countries via more than a hundred private and public training sessions since 2004 on these standards.

For more information download pdf of Octagon's Data Standards Consulting (DSC) datasheet.

For more information download pdf of Octagon's Data Standards Consulting (DSC)
Group Involvement with CDISC Teams datasheet.