Statiza Statistical Services

www.statiza.in

Statiza Statistical Services, an endeavor of statistics offers Statistical Services, Regulatory Assistance, Professional Training, Statistical Consultation, Collaboration and Education outreach to support Pharmaceutical Industry, Educational Institutes, Government Agencies and Researchers. Statiza empowers and accelerates your research or study by providing sound statistical assistance, resources and profound training about research methods, experimental design statistical computing and helping independent use common statistical packages for the data analysis. We have experience across a broad range of biostatistics applications in pharmaceutical industry and offer help with all aspects of data-based research for BA/BE studies, Phase I-IV Clinical Trials, DRC-Vasoconstriction Studies, Personal Healthcare studies and Statistical Support to Product Development & Manufacturing. We provide training on professional courses which are specifically designed considering in-depth requirements of professionals and researchers. We provide following services: - Study design - Statistical inputs in synopsis/protocol - Sample size calculation - Statistical analysis plan (SAP) & Mock Tables, Listings and Figures (TLFs). - PK/PD analysis, Steady state simulations, Bootstrapping. - Statistical analysis and Interpretation. - Statistical sections of clinical study report (CSR) or stand alone statistical report. - IVIVC/R for BE studies. - CDISC package- SDTMs, ADaMs, Pinnacle validation, SDRG, ADRG, define file. - Product and process development (Quality by Design initiative) by planning experiments (e.g. Design of Experiments, specification design, optimization), statistical analysis and reporting. - Dissolution similarity using multivariate techniques, Stability extrapolation. - Statistical Quality/Process Control Methods, Out of Trend (OOT) Analysis. - Regulatory assistance - Professional training - Statistics system or unit set up in the company.

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Statiza Statistical Services, an endeavor of statistics offers Statistical Services, Regulatory Assistance, Professional Training, Statistical Consultation, Collaboration and Education outreach to support Pharmaceutical Industry, Educational Institutes, Government Agencies and Researchers. Statiza empowers and accelerates your research or study by providing sound statistical assistance, resources and profound training about research methods, experimental design statistical computing and helping independent use common statistical packages for the data analysis. We have experience across a broad range of biostatistics applications in pharmaceutical industry and offer help with all aspects of data-based research for BA/BE studies, Phase I-IV Clinical Trials, DRC-Vasoconstriction Studies, Personal Healthcare studies and Statistical Support to Product Development & Manufacturing. We provide training on professional courses which are specifically designed considering in-depth requirements of professionals and researchers. We provide following services: - Study design - Statistical inputs in synopsis/protocol - Sample size calculation - Statistical analysis plan (SAP) & Mock Tables, Listings and Figures (TLFs). - PK/PD analysis, Steady state simulations, Bootstrapping. - Statistical analysis and Interpretation. - Statistical sections of clinical study report (CSR) or stand alone statistical report. - IVIVC/R for BE studies. - CDISC package- SDTMs, ADaMs, Pinnacle validation, SDRG, ADRG, define file. - Product and process development (Quality by Design initiative) by planning experiments (e.g. Design of Experiments, specification design, optimization), statistical analysis and reporting. - Dissolution similarity using multivariate techniques, Stability extrapolation. - Statistical Quality/Process Control Methods, Out of Trend (OOT) Analysis. - Regulatory assistance - Professional training - Statistics system or unit set up in the company.

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