Standardized Data (SDTM)
Regulatory submissions and data integration require a standardized approach.
Our experts assist in converting clinical data into CDISC SDTM (Study Data Tabulation Model) format or other customer-specific formats, ensuring compliance and consistency.
Regulatory-Compliant Data Formatting
Converting raw data into submission-ready formats.
CDISC SDTM Expertise
Aligning study data with latest industry standards.
Seamless Integration
Supporting interoperability with data warehouses and regulatory systems.
Regulatory Biostatistics Support
Strategic input for FDA/EMA meetings and submissions