CIMS is pioneering Dynamic Data Monitoring with a vision of reshaping the future of clinical trials. We are empowering pharmaceutical and biotech companies to bring drugs to market sooner, saving millions of dollars on clinical trials and bringing much-needed therapies to patients faster.

In 2010, the FDA released the final rule for investigational new drug (IND) safety reporting requirements for human drug and biological products. A 2021 draft guidance offers more detailed information on the responsibilities of sponsors regarding the monitoring and reporting of safety data, emphasizing proactive safety management and the need for a systematic approach to safety surveillance. The draft guidance underscores the importance of assessing safety information not only on a case-by-case basis but also in the context of aggregate data from all sources.