MacroStat (Shanghai) Pharmaceutical Development Co., Ltd. (hereinafter referred to as MacroStat) is committed to providing customers with clinical trial services, pharmaceutical research data analysis support and other related services.
MacroStat was founded in 2005. Its clinical trial services are comprehensive, including the design of clinical trial schemes, the design and establishment of databases, the design of case report forms, the management of data, the writing of statistical analysis plans, the establishment of CDISC/SDTM/ADaM and analytical data sets, the use of SAS for statistical analysis, making of statistical charts and data lists, statistical analysis on new drug comprehensive efficacy (ISE) and safety (ISS) reports, the writing of independent statistical reports, registration of clinical trial report for reporting, attending review meeting of a drug administration in the United States or China, answering data statistics questions, and supporting drug registration and reporting.
In addition, MacroStat also provides statistical analysis services for the FDA New Drug Review Committee and the Data Security Committee, and it offers statistical support for clinical researches reporting to regulatory authorities in Europe, the United States, China, Japan, Australia and other countries and regions. It also provides data analysis support for research manuscripts and publications in medical fields (especially tumors). The company has extensive CDISC experience to support global reporting and legacy data conversion.
MacroStat is actively engaged in international business cooperation. It started to cooperate with Eli Lilly and Company in 2006, which is not only the company’s first global client, but also its largest client. Their cooperation areas range from animal healthcare to health results and exploration analysis to comprehensive summary and analysis of FDA Phase III reporting research, safety and effectiveness in important areas. In the past two years, MacroStat's main contribution to Eli Lilly was the statistical analysis of the latter’s two important compounds in the FDA reporting, including several important FDA reporting for key phase III trials and ISS/ISE, which are two of Eli Lilly's most promising products. This time, MacroStat, standing out among the participating 1,000 suppliers across the world, won the Eli Lilly Global Supplier Award.
MacroStat is committed to developing clinical data management software suiting China's national conditions and meeting the requirements of European and American drug administrations. Currently, domestic pharmaceutical companies, medical colleges and research institutions do not have professional clinical data management software, and they generally use free epidemiological data entry software EpiData. This software is simple but does not meet the requirements of the US FDA and European EAMA. However, foreign professional clinical data management platform software is expensive (over one million dollars), which is unaffordable for domestic pharmaceutical companies. Therefore, in order to meet the needs of domestic pharmaceutical companies and improve clinical trial data management level in China, MacroStat is dedicated to developing compliant clinical data management software.
In the future, MacroStat will more actively carry out international cooperation, strive to promote and accelerate the process of drugs entering the market in the industry on a global scale. The company will also provide strong data support for clinical data and data foundation for its pharmaceutical partners.