Precision-Driven Insights for Regulatory-Grade Clinical Outcomes
Expert guidance on statistical methodologies aligned with regulatory expectations. Support for pre-IND meetings, protocol reviews, and regulatory agency interactions.
Selection of optimal design methodologies tailored to the therapeutic area and objectives. Adaptive design strategies and innovative trial designs as required.
Accurate and defensible sample size calculations using advanced statistical models. Justification based on expected treatment effects, power, and significance levels.
Generation of randomization schemes and Interactive Web Response System (IWRS) integration. Stratified or block randomization schedules to minimize bias and ensure balance.
Development of comprehensive SAPs detailing all planned analyses. SAPs fully aligned with protocol objectives and regulatory standards including USFDA, EMEA, ICH-GCP E9/E3.
Programming of datasets, analysis variables, and outputs using CDISC standards (SDTM, ADaM). Validation of all programming deliverables through robust QC processes.
Design and execution of interim analyses with pre-specified stopping rules. Support for DSMB/IDMC meetings and adaptive trial decisions.
High-quality, publication-ready TLFs for inclusion in clinical study reports and submissions. Custom visualizations for clear data interpretation and review.
Full statistical contribution to Clinical Study Reports (CSR). Integrated Summary of Safety (ISS) and Efficacy (ISE) support for regulatory dossiers. Compilation of statistical outputs for eCTD submissions.