Written by Wassim Aldairy, Head of Pharmacovigilance and Clinical Safety @ Cerevel Therapeutics
When implementing a pharmacovigilance system at Cerevel it was very important to us to document and track all actions related to drug safety. As a clinical stage company, those requirements included tracking signals from non-clinical sources, any safety related clinical datasets such as vital signs, lab values, and safety scales, and of course traditional clinical sources such adverse event data.The tracking of a non-clinical signal throughout the lifecycle of a drug requires a number of steps. The insight created from these actions need to be stored in an accessible and usable format, rather than in troves of emails, note-to-file repositories, or shared drive documents. A single, all-encompassing system for pharmacovigilance activities ensures ease of knowledge retention and transfer.
Take for example a fictional drug that shows an effect on end organ in an animal during early clinical development. Tracking the decisions, rationales, and actions taken based on the observed effect in animal, including any monitoring steps in clinical studies, can make future assessments more efficient. If a clinical safety signal is seen later in trials or when the drug is on market, it will be important to draw on the data and insight (i.e. lifecycle of a signal) from the prior non-clinical activities.
Properly tracking and recording activities now saves time and money in the future. Having a dynamic process for accessing and using these data and decisions allows me to leverage what would otherwise be routine pharmacovigilance activities into an asset that benefits the entire organization.
In researching the market for a data, analytics, and software solution that could meet my goals, I knew fit-for-purpose software was my only choice. I chose Advera Health Analytics’ Evidex platform. The flexibility that Evidex provides, both from back-end cloud-based infrastructure and front-end user interface and experience, made it the clear winner.
Cerevel was able to quickly configure Evidex to handle both clinical and non-clinical signal workflow and create a document repository for all safety related files and meeting-minutes. Cerevel is working to integrate our CRO-hosted safety database into Evidex later this year. This will improve access and reporting on our safety database. The integration will allow us to fulfil FDA regulations for causality assessments in real-time and log signals into the platform as necessary.
The value Evidex provides for the cost of the system is incredible. It allows a clinical stage company like Cerevel to leverage data, processes, and analytics developed in the pharmacovigilance department throughout the lifecycle of a drug.