Over the course of the last blog posts, the requirements of the four stages of the GVP Module IX Signal Management (GVP IX) process were discussed in great detail, along with specific ways in which Evidex Signal Management can help an organization to efficiently meet GVP IX requirements in a single, user-friendly, easy to implement platform built on a foundation of safety data and analytics.
The overarching theme throughout all stages of GVP IX, is that the processes used should be adequately documented and the steps taken in the management of a specific signal should be tracked and auditable. In short, the system needs to provide for transparency into the who, what, why, and when of the process.
Evidex Signal Management is fully validated with an off-the-shelf configuration based on GVP IX. This validation allows an organization to meet quality management requirements (see GVP Module I). It also provides much of the required documentation needed regarding the signal management system, decreasing the burden on organizational resources.
Evidex Signal Management also provides for transparency into all activity, as well as custom reporting tools so that organizations can quickly produce justification / evidence for the steps taken and decisions made in the signal management process. Full, audit ready reports can be produced in seconds eliminating last minute scrambles to produce required documentation.
As mentioned in a blog post Signal Management for Pharmacovigilance 2.0, the concept of software to solve the burden of tracking safety issues is not new. Legacy systems have outdated user Interfaces, long and costly implementation periods, and outdated analytic tools.
Evidex Signal Management, with a best-in-class user interface, fast validated implementation, and an advanced data-and-analytics-first approach, provides drug safety departments with a new option. The option to not settle for an intimidating user experience, long costly implementations, or a band-aide approach to data and analytics focused workflows.
You no longer need to settle for the status-quo and legacy software.