Biostats Statistical Consulting Ltd

BioStats Statistical Consulting Ltd. is a boutique biostatistics and clinical data consulting firm specializing in regulatory-compliant statistical analysis and data management solutions for pharmaceutical, biotech, and medical device companies. We provide expert statistical consulting, study design, data management, and EDC solutions, ensuring compliance with FDA, EMA, and ICH-GCP standards: Study Design & Sample Size Calculation (adaptive, crossover, phase I/II) Statistical Hypothesis & Endpoint Development Randomization & Statistical Analysis Plans (SAPs) Interim & Final Statistical Analyses Regulatory Submission Support & Agency Representation Manuscript Preparation & Scientific Consulting & : Case Report Form (CRF) Design & Review EDC System Setup & Trial Management (Dacima, Castor, etc.) Database Build, Data Cleaning, & Quality Control Medical Coding & Regulatory Data Standardization Discrepancy Management & Data Integration With cutting-edge statistical expertise and seamless data solutions, BioStats ensures your clinical research is scientifically rigorous, regulatory-compliant, and publication-ready. Get in touch to optimize your clinical research today!