Ami Desai's Contact Details

Ami Desai's Company Details

STAR IT TECHNOLOGY

Mumbai, Maharashtra, India • 3 Employees
Pharmaceuticals

The story of our company trails back from 2010, when we started dealing with specialization in Data Analytics, CDISC data preparation , PK and statistical data analysis in Human data science, Clinical trials (All phases), Life science, Bio statistics, Medical writing, finance and Retails industries.The current initiative with the rise of Star IT Technology, at present terms, mainly focuses on providing consulting services to pharmaceutical and life science industry in the entire clinical development cycle – protocol development, study design, and Clinical Data Management, SAS Programming, statistical analysis, Data Migration, CDISC Data Conversion, and regulatory submission. We are proud of being able to provide quality submissions to FDA, which accelerates time for companies to market for the product, bringing the benefit of new treatments to patients sooner, and maximize research investments, and conserve patent life.Star IT Technology presently devoted to providing the following services:Clinical Data ManagementBio statisticsCDISC MigrationOur services include:Statistical Input to Protocol/Study Design Development • Sample size calculation, Statistical Inputs in Protocol & SAP development● Randomization Schedule● Review of CRF and Data Management Plan● Statistical Analysis Plan (SAP) and Mock-up Shells● Analysis of Safety, Efficacy Data for CSR and Regulatory submissions● SAS Programming – SDTM/Adam Datasets and Tables, Listings, Figures● Design and Deployment of System-level SAS Macros● PK/PD Analysis● Integrated Safety and Efficacy Analysis (ISS/ISE)● Analysis of BA/BE Studies, Meta-Analysis● Statistical Report Writing● CDISC Migration for BE: For complete project submission