Pharmacovigilance As-A-Service (PVaaS) Provides Key End-To-End Support To Meet Pharmacovigilance Needs For A Specialty Pharmaceutical Company

Background
Pharmacovigilance (PV) broadly describes the collection, analysis, monitoring and prevention of adverse effects in drugs and therapies. As regulations continue to emphasize patient safety, PV will continue to play an important role in drug development. Staying current on regulatory changes and having the ability to diligently monitor safety-related information can be challenging for companies, especially those without in-house PV expertise.

Situation
A specialty pharmaceutical company focusing on the areas of pain management and addiction medicine decided to outsource their PV support due to growing demands on their limited resources and lack of in-house PV database. The company was also concerned about an outsourcing model from a cost perspective.

Solution
Bioclinica was chosen as the PV provider and instituted their end-to-end PV-as-a-Service (PVaaS) model, which provides PV services and management of the underlying applications and infrastructure. Bioclinica collaborated with the software and hosting vendor to deliver the services, including infrastructure and application hosting, system implementation, application and infrastructure support and business process support. The transition to Bioclinica occurred in two phases: pilot and go-live. During the pilot phase, a predefined number of activities/transactions was executed, and client feedback was actively solicited. After the success of the pilot, the go-live phase was approved, and the project team executed per the agreed-upon project plan.