Case Study - Pharmacovigilance

A need came our way for pharmaceutical representatives to have a secure FDA validated pharmacovigilance platform which will be used for the collection of Adverse Drug Reactions (ADR) during their regular customer visits.

Technical Requirements

1. The platform should be fully validated according to the FDA CFR Part 11 guidelines.

2. The platform should have full role-based access to ensure different users from different pharmaceutical companies can’t access each other’s information.

3. Real time reporting with automated notifications are needed for serious events.

4. The ability for the platform to be device agnostic was a big requirement.

Solution

1. We suggested making use of our Safetybase product which is mainly used for In-Trial surveillance related to the capturing and management of Serious Adverse Events.

2. Our platform is fully configurable which allowed us to define the ADR template of the respective pharmaceutical companies within days.

Conclusion

1. Multiple pharmaceutical reps in a number of different countries are using the platform on a regular basis.

2. The automated letter/report generator function has saved the field workers hours and the cloud-based platform allows for the Safety teams of the pharmaceutical companies to communicate directly with the reporter of the event via the platform using push notifications.