Welcome to Vinilytics
Biostatistics and Statistical Programming
Turning biostatistics and programming into strategic power for the next era of clinical development.
Study Design & Strategic Planning
Establishing the foundational statistical architecture to ensure trial validity and regulatory alignment.
Protocol DevelopmentStatistical input into design, objectives, and endpoints.
Power & Sample SizeRobust determination of study sensitivity through advanced calculations.
Randomization ServicesManagement of IRT/IWRS and high-fidelity scheme development.
Advanced MethodologiesExpertise in Adaptive Designs and Bayesian frameworks.
Statistical Analysis Planning
Defining interpretation logic—bridging raw data points with regulatory conclusions.
SAP & Mock ShellsComprehensive plans and detailed TFL output shell architecture.
Blinded Data ReviewOversight of BDRMs and quality check programs prior to lock.
Interim AnalysisExecution of efficacy or futility analyses with rapid reporting.
Data Standardization & CDISC
Ensuring absolute submission-readiness through rigorous adherence to global data catalogues.
SDTM & ADaM GenerationSubmission-ready datasets with metadata and Define.xml.
Legacy Data ConversionMapping legacy data into modern, standardized formats.
Automation PipelinesUtilizing specialized macro libraries for consistency and speed.
Programming & TFL Production
Generating high-precision evidence for medical oversight and regulatory review.
Analysis DatasetsADaMs optimized for hypothesis testing and subgroup analysis.
TFL ProductionQuality Tables, Figures, and Listings for CSRs and publications.
Advanced VisualizationGraphics designed for efficacy trends and safety signals.
Safety Monitoring & Committee
Independent statistical support to safeguard patient safety and trial integrity.
DMC/IDMC SupportPreparation of independent report packages for Closed sessions.
SRC MonitoringRoutine safety reviews and standardized IND safety updates.
Regulatory & Integrated Summaries
Strategic bridging of clinical data to successful regulatory approval and dissemination.
ISS/ISE IntegrationPooled analysis for summaries of Safety and Efficacy.
CSR Package DeliverablesAuthoring statistical sections and providing overall representation.
Post-Submission SupportTechnical guidance for queries raised by regulatory authorities.