MacroStat provides services for protocol development, database setup, case report forms design, data management, statistical analysis plans, CDISC and analysis datasets generation, SAS programming, data and safety monitoring board (DSMB) support, integrated summaries of efficacy (ISE) and safety (ISS) for new drug applications (NDA), clinical and statistical reports, and NDA submissions to the regulatory agencies worldwide.
MacroStat is an international Contract Research Organization (CRO) providing data management, statistical analysis, and report writing services to the pharmaceutical, bio-tech, and medical device industries, and National Institutes of Health (NIH). MacroStat was founded in Delaware, US in 2002 and China branch was established in 2005.
It has extensive experience in various therapeutic areas such as pain control, oncology, cardiovascular, respiratory, central nervous system, anti-viral, antibiotic, and gastro-intestinal system, etc.