Statistical Analysis and Data Management

Nanjing Acumen Medical Information & Technology Co., Ltd. (AMIT) is a wholly owned subsidiary of R&G and provides high-quality professional services in statistical design, analysis, programming and data management for customers worldwide. AMIT is led by former Johnson & Johnson US and FDA statistical experts Dr. Gang Chen and Dr. Kun He, and several core members of its management team have served in Pfizer, Johnson & Johnson, Eli Lilly and other multinational pharmaceutical enterprises. It has more than 200 professionals in statistics, computer programming and data management, has established data and statistics science centers in Nanjing and Hefei, and has offices in Shanghai, Beijing, Wuhan, Chengdu, Maryland and New Jersey, USA.

Since its establishment in 2012, AMIT has established a complete project management process, SOP quality management and information security system (ISO9001/ISO27001), and has served more than 400 phase 1, 2, 3 and post-marketing clinical trial projects from more than 200 pharmaceutical enterprises. AMIT is a member of the International Clinical Data Interchange Standards Consortium (CDISC) and has assisted sponsors in completing more than 30 NDA/BLA applications that meet CDISC standards.

In line with the purpose of shortening the R&D cycle, improving the success rate of R&D and reducing R&D costs, AMIT strictly follows the requirements of regulatory guidelines and relevant regulations on drug R&D and provides customers with scientific and reasonable design and strategies and project implementation that meets GCP global quality standards. AMIT has played a very important role in helping local and overseas pharmaceutical enterprises develop and marketing new drugs over the past few years.

Key success cases include:

Enriched design strategies were used to help a pharmaceutical company successfully obtain marketing approval for an innovative drug from the NMPA;

Innovative design concepts (such as adaptive design) were used to help a small pharmaceutical company’s product be successfully acquired by another large pharmaceutical company;

Help pharmaceutical enterprises scientifically and rationally organize and interpret trial results and participate in effective communication with FDA, so that the drug can successfully be approved by FDA for marketing;

Successfully help pharmaceutical enterprises to successfully obtain the marketing approval from NMPA using the early trial results (interim analysis); participate in supporting the research and development and successful marketing of the first domestic PD-1/PD-L1 monoclonal antibody product.

AMIT provides comprehensive services related to data in drug R&D - services include:

Drug development strategy development, top-level design, clinical trial protocol development, statistical method consultation;

Phase 1-4 clinical trial CRF design, EDC database establishment, data management, statistical programming and analysis, and statistical analysis report writing;

Statistical analysis related to the Clinical Trial Independent Data Monitoring Committee (IDMC);

NDA/BLA application, including NMPA, FDA, EMA, PMDA.