LBRIA’s biometric services team provides advanced statistical and analytical expertise to support the design, analysis, and interpretation of clinical studies across all phases of development.
Our Master Level and PhD-level Statisticians bring deep knowledge of scientific, regulatory, and industry requirements, with extensive experience supporting regulatory submissions and health authority interactions.
BIOMETRIC SERVICES
Our regulatory experience includes New Drug Applications (NDAs), Premarket Approval (PMA) submissions, 510(k) clearances, Integrated Summaries of Safety and Efficacy (ISS/ISE), and litigation support. Across a broad range of therapeutic areas, LBRIA biometric experts contribute critical insight that strengthens study design, supports data-driven decision-making, and enhances the overall success of clinical programs.
LBRIA has significant experience with innovative and adaptive trial designs, including continual reassessment methods, biomarker-driven treatment allocation and patient selection, group sequential designs, seamless Phase II/III studies, single-protocol SAD/MAD designs, sample size re-estimation, and futility and superiority stopping rules. This depth of expertise enables more efficient trial execution, reduced development timelines, and an increased probability of clinical study success.
Our statisticians integrate fully with project teams and remain engaged from study planning through final analysis and regulatory review. We apply rigorous attention to detail across scientific content, regulatory guidance, and data standards, including CDISC, SDTM and ADaM, to ensure analyses are accurate, defensible, and submission-ready. LBRIA’s collaborative, end-to-end approach ensures alignment with sponsor objectives, timelines, and quality expectations.
BIOMETRIC SERVICES
LBRIA provides a comprehensive range of biometric services, including:
Regulatory strategy and health authority meeting support,
Statistical Analysis Plans (SAPs) and Interim Analysis Plans,
Phase I–IV primary safety and efficacy analyses,
Innovative and adaptive trial design and analysis,
Biomarker and novel endpoint development and validation,
Diagnostic and Receiver Operating Characteristic (ROC) analyses,
Exploratory and integrated data analyses, including meta-analyses,
Statistical sections of study protocols and clinical study reports,
Data Safety Monitoring Board (DSMB) support,
Product registration, defense, and regulatory response support,
Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE),
Study remediation and reanalysis.
