CDISC Services

CDISC Conversions

Octagon is pioneering the clinical information workflow from collection to submission and beyond. Our Data Integration and Standardization (DIS) team was formed to help the industry create CDISC-compliant datasets that are “submission ready”. To date, DIS has converted numerous studies to SDTM including the therapeutic areas of Oncology, Endocrinology, CNS and Cardiovascular. Since Octagon employs 2 of the 6 primary authors of the Study Data Tabulation Model, DIS team members are fully trained and have access to these thought leaders on a daily basis.

Services we offer are:

• Convert legacy data to SDTM compliant datasets
• SDTM compliant pooled database for ISS/ISE analysis
• Data Warehouse design and conversion

We have forged a new model for clinical data workflows that transforms chaos into clarity and provides an integrated vision for data collection, management, storage, analysis, review and submission.

CheckPoint Data Validation

Octagon's CheckPoint facilitates the early detection of potential data conversion and compliance issues. Our internal expertise allows us to offer deeper insight by going beyond the standard automated checks and providing optional guidance in interpretation and correction of data compliance issues.

Our three-tiered approach offers flexibility and provides an opportunity for clients to leverage our expertise to improve data integrity. Through this service, clients may look to Octagon for:

• Basic Validation: Octagon conducts basic validation of datasets (105 FDA checks, plus 4 JANUS checks). Client receives a standard report listing any validation issues.
• Enhanced Validation : Octagon conducts enhanced validation, which goes above and beyond the basic validation and includes an additional 200 checks that verify SDTM compliance. Deliverable to client includes a prioritized list of issues identified during enhanced validation.
• Expert Consulting : Octagon conducts enhanced validation in concert with expert consulting. Once datasets are validated, Octagon's expert consultants work with the client to resolve issues and refine processes.

Octagon's enhanced validation offers extended value by raising the bar on compliance checks. Our additional checks:

• Cover both safety and non-safety standard domains defined in the SDTM Implementation guide
• Verify all variables with SDTM controlled terminology
• Fully recognize all forms of ISO 8601 date/time duration
• Validate metadata between SDTM datasets and define.xml

Competitive offerings require high-priced software license fees or rely on error-prone, manual checks. CheckPoint combines Octagon's practical knowledge of CDISC SDTM with automating technology to provide a cost effective alternative.

For more information about Octagon's CheckPoint Data Validation services
>>Download PDF of CheckPoint Datasheet, or Contact Octagon.

For more Information about Octagon’s CDISC Solutions Contact Octagon.