"Emergency Turnaround" - Pharmacovigilance System Implementation
Overview
A top 20 Pharmaceutical firm had been pursuing the upgraded implementation of a global Pharmacovigilance (PV) system (ArisGlobal), spending approximately $3M over the course of a 3-year period. Unfortunately by the fall of 2016, due to a number of challenges, the program team had not fully aligned on requirements across its disparate user groups and had not yet developed a working prototype of an upgraded environment. In short, the Requirements and Analysis phase was incomplete and the Testing, Training and Release phases had not begun.
In November 2016, facing increasing pressure from its executive team as well as a looming upgrade deadline from the European Medicines Agency (EMA, the EU’s equivalent of the FDA), this client called upon eta one solutions to assume program management responsibilities from an “emergency turn around” perspective.
Given the high risk, vast scope and hard timelines for this client, eta one's executive leadership team became directly engaged in this initiative and was directly involved with the delivery and execution.
Target
Provide for the worldwide rollout of a fully validated, R3 Compliant (Import), upgraded PV system in advance of the EMA’s November 22nd, 2017 deadline.
Solution Delivery
This program centered on a highly complicated, major upgrade of the client’s PV system. In reality, however, delivery of this initiative also involved many additional sub-projects including the upgrade/implementation of:
R3 Compatibility (Import)
Transmission networks (needed for the secure transmission of data between our client, its partners and Health Authorities)
XML Interface (interface engine needed to ensure successful, automated transfer of data from source systems to the PV system)
Case Exchange (engine needed to move cases between the various parts of our client’s PV system)
A Business Intelligence Reporting Platform (needed to enhance and ensure compatibility of system reports with the overall upgraded PV system)
Results
On November 20, 2017 this client in partnership with eta one solutions was able to release a validated, R3 Compliant (Import) PV system to its user community and health partners. By leveraging eta one's leadership and experience, our client overcame several technical and organizational barriers and successfully achieved their goal.
