Data Integration and Standardization
Octagon’s Data Integration and Standardization (DIS) team delivers the solutions and clinical expertise that drive submission development, meet regulatory requirements, and facilitate efficient review at the FDA. Our experts have a wealth of experience as data managers, programmers, and statisticians and possess deep understanding of the principles and technical details of the CDISC Study Data Tabulation Model (SDTM).
Octagon SDTM Data Conversion services include:
- Conversion of legacy data to SDTM compliant datasets
- Development of SDTM compliant pooled database for ISS/ISE analysis
- Sponsor-defined data warehouse design and conversion
Sharp Focus on Initial Processes
We evaluate all inputs to the process to ensure the delivery of the right solution from the start. Our source driven mapping specification process ensures that all available is considered for migration to CDISC domains.
Connecting Clinical and Regulatory – Seamlessly and Efficiently
The DIS team has been converting legacy datasets in multiple therapeutic areas to the CDISC SDTM standard for the last six (6) years. We have processed more than seven hundred (700) trials encompassing over fourteen thousand (14,000) domains for over sixty-three (63) companies leading to more than seventy-eight (78) regulatory data submissions across numerous therapeutic areas.
Proven Leadership in SDTM Data Conversion
Octagon employs two of the six primary SDTM authors giving you access to unparalleled technical and thought leadership. This experience is at the core of the technically-sound solutions that make a measurable impact on the analysis and regulatory review phases of the clinical data lifecycle.
Quality, Submission-Ready Deliverables
By using metadata from the final SDTM domains in the publishing process we ensure consistency between data, definition tables, and annotated CRFs. Clients gain the confidence of knowing that there final deliverables are inherently submission-ready.
"I feel very connected and in-sync with my Octagon counterparts. They're always there to answer questions whenever they're called upon. We’re not a large pharma company but I feel like we’re treated the same."