MacroStat Inc. Email Format
Pharmaceutical ManufacturingDelaware, United States51-200 Employees
MacroStat Inc. operates in the pharmaceutical manufacturing space, offering specialized support for clinical trial data activities and regulatory submissions. Its scope includes study design, protocol development, sample size calculations, database setup, case report form design, data management, and statistical analysis planning, with CDISC SDTM/ADaM and analysis dataset generation. The company also provides SAS programming, data and safety monitoring board support, and integrated summaries of efficacy and safety for NDA filings, along with the preparation of clinical and statistical reports for regulatory authorities. Its services are aimed at pharmaceutical sponsors and other stakeholders conducting clinical trials, addressing regulatory requirements and the needs of NDA submissions. Headquartered in Hockessin, Delaware, MacroStat positions itself as a mid-sized provider within the pharmaceutical services sector.