The problem of high risk, long period and high cost is one of the biggest pain points for pharmaceutical companies, with lots of time spending in clinical trials. As the innovative drug companies develop rapidly in China, the time lag between the launch of imported drugs has narrowed, and new drugs are facing new challenges from pre-launch stage to post-launch stage.
As an integrated platform, Bioknow eClinical can tackle these problems efficiently. This platform is able to reduce data cleaning and research management time by 30% and reduce overall project cost by 40%. The informatization of clinical research brings significant cost-effectiveness to the internal, and it can also help all parties in clinical research deal with external challenges such as stricter regulatory environment better.
From the external environment, the regulatory environment and requirements are becoming stricter. In 2017, China joined ICH, which means China’s drug regulatory authorities, pharmaceutical industry and R & D institutions will gradually transform and implement the highest international technical standards and guidelines, which also challenges the management of domestic clinical trials. For the pharmaceutical industry itself, clinical trials can only be carried out if an information system is used in such an era of precision medicine. Clinical trials are inefficient and cumbersome especially in China. Taking the application of EDC system as an example, the foreign use rate has reached 90%, while the domestic use rate is only 30%-40%.
According to these problems, Bioknow eClinical integrated clinical data solutions, project management solutions, document management solutions and security management solutions. Its value is to integrate different systems, which makes it possible to manage the progress and cost of multiple projects on one platform, to cooperate with different people in different regions. Besides, using only one entry can reduce duplicate data entry and project management in isolation efficiently.