CLINICAL PROGRAMMING
LBRIA delivers comprehensive clinical programming services to support the accurate collection, standardization, analysis, and presentation of clinical trial data across all phases of development. Our clinical programmers work in close collaboration with data management, biostatistics, and regulatory teams to ensure data are submission-ready and aligned with FDA, ICH, and global regulatory requirements.
Expertise & Quality in all our Processes
LBRIA programmers have master degrees in Statistics or more than 15 years of experience working with CDISC standards. LBRIA brings significant expertise in the development of SDTM and ADaM datasets and the preparation of complete regulatory data packages. Source data are prospectively mapped using controlled terminology to ensure consistency, traceability, and regulatory compliance from clinical databases through final analyses and outputs.
Quality is embedded throughout our programming processes. LBRIA applies rigorous, risk-based quality control methods— including manual review, dual programming, and industry-standard compliance tools — to verify the accuracy and integrity of datasets, tables, listings, figures, and metadata. All deliverables are fully documented and maintained in an inspection-ready state.
CLINICAL PROGRAMMING SERVICES
LBRIA offers comprehensive clinical programming services, including:
Database and eCRF design,
CDISC-compliant SDTM and ADaM dataset development,
Tables, listings, and figures (TLF) generation,
Define-file preparation and submission metadata,
External and legacy data integration,
Integrated clinical programming support for ISS and ISE,
Dual-programmed quality control of deliverables.
