Establish a Lean, Efficient and Consistent SAE Management process
Clinical Research Organizations (CROs) and Pharmaceutical companies have a regulatory responsibility of distributing SUSAR and other safety documents originated from sites to Ethics Committees, IRBs, others within the mandated timelines. The SUSAR information may be distributed using standard formats such as CIOMS, MedWatch or using custom defined formats based on the specific study needs. The process of handling and distribution of safety documents is currently managed using manual or semi-manual methods leading to reduced process efficiency, lack of clear oversight, increased costs etc.
How Do We Deliver
PVSentinel SUSAR Distribution is a component of our PVSentinel platform. It can be deployed on its own or in combination with other modules of the platform.