Safety departments at Marketing Authorization Holders & Regulatory Authorities are under pressure from all sides. They must constantly stay on top of compliance while managing ever-increasing pharmacovigilance case processing volumes and at the same time elevate more strategic activities, including risk mitigation and data analysis – all with fewer people and resources.
There is an enormous need to adopt a more integrated, standardized approach to drive compliance with higher quality and at a lower cost.
Pharmacovigilance: Under the Pump
While pharmacovigilance is a critical part of the product lifecycle, unfortunately it continues to be regarded as a cost center and not a long-term investment into patient safety. In this environment, safety must find a way to automate operational activities in order to allow the focus on areas where it brings greatest value: signal detection in drug safety, pharmacovigilance (PV) analytics and benefit-risk assessment. They must enhance the way they manage, store, validate and even understand data.
That’s not to say that Individual Case Safety Reports (ICSRs) aren’t a central regulatory requirement, however the focus has already shifted greatly from the individual to population insights and that requires pharmacovigilance to take a meaningful data analytics approach.
For many pharmacovigilance departments – too often, battling with poorly integrated pharmacovigilance software, outdated standard operating procedures and several manual processes — the reality is that volume increases, as well as other reporting obligations, create huge strains. As such, achieving clear PV data analytics is very challenging because the bulk of effort is spent on activities that result in meeting regulatory submission timelines.
There is no doubt that cloud-based platforms enable better integration and easier, more expeditious upgrades, but that also depends on the type of cloud and the type of options made available to pharmacovigilance departments.
Doing Less with Less
Rather what is required is a multi-tenant cloud-based software solution that is built on industry best practices and is pre-validated so that life sciences companies can gain efficiencies and achieve lower costs. To meet compliance, manage benefit-risk assessment, and successfully tackle signal detection while enabling analytics, what’s needed is an integrated and streamlined end-to-end process for capturing, processing, reporting and benefit-risk analysis of adverse event cases.
We believe that life sciences industry-changing platform needs to incorporate functionalities around automation and cognitive computing to facilitate better decision making from pharmacovigilance case management software. Having better oversight and analytics capabilities will result in more rigorous patient safety management, decreased overhead and greater information transparency.
As pharmacovigilance continues to struggle with resource challenges combined with a growing shift to risk prevention and value-added capabilities and away from simply case processing, having a solution that can adapt with them becomes all the more important. We believe a solution that enables seamless integration from case receipt to benefit-risk assessment, that supports agile compliance to evolving safety regulations and that increases productivity is the way forward. That’s why we’ve launched LifeSphere® Safety, which adopts a TCO approach to tackle the multiple challenges that patient safety data management & interpretation faces.