Medical data platform company JNPMEDI has announced the launch of a new drug safety management solution, 'Maven Safety'.
With the introduction of the mandatory application of E2B(R3), an international standard form for reporting adverse drug reactions, in 2021 and the requirement for the Development Safety Update Report (DSUR) from 2022, regulations are being tightened. However, many sponsor companies find it difficult to introduce existing safety DB management (safety data management) software due to the high initial construction and maintenance costs.
To address this issue, JNPMEDI has introduced Maven Safety, which can maximize work efficiency at a reasonable cost by implementing a subscription-type SaaS solution that selects and uses only the necessary functions according to the size of the project without installing a separate product. Through this, small and medium-sized companies, which had difficulty introducing expensive software, can conveniently and easily manage data in accordance with international standard formats. It is expected that companies that used existing software will be able to significantly reduce costs by using Maven Safety.
Maven Safety has strengthened its service competitiveness by focusing on three major areas: ▲ optimization of reporting to regulatory agencies, ▲ collaboration-based safety data management, and ▲ expansion of clinical research productivity. First, it provides a data input function tailored to the E2B(R3) form for reporting to domestic regulatory agencies, and it is possible to convert XML files for data reporting with one click. The entered data is recorded in the form of a DB to help systematic management.
Another strength is the ease of collaboration-based safety data management. Workspaces and folders can be created within the product, enabling efficient work. Workspace can set access rights according to users, so it is possible to work simultaneously with various collaborations as well as users inside and outside the organization.
Furthermore, in order to secure data integrity and prevent manipulation of clinical data, an audit trail function is provided, and all written histories are stored. Through the approval function, mutual review of the entered data is possible, and through the comment function, it is possible to share opinions on the entered items, increasing the collaboration efficiency of pharmacovigilance work. In addition, it provides a blind function for medicines to optimize the use of clinical data, so that data can be conveniently managed even during clinical trials. In the future, it will support optimal data management and maximize clinical research productivity through linkage with Maven CDMS.