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EVERSANA’s president of compliance services discusses the launch of EVERSANA ORCHESTRATE PV.
Vikram Anand
President
Compliance services
EVERSANA
EVERSANA’s president of compliance services Vikram Anand spoke with Pharmaceutical Executive about the launch of EVERSANA ORCHESTRATE PV, a pharmacovigilance solution for the pharma industry.
Pharmaceutical Executive: What is ORCHESTRATE PV all about?
Vikram Anand: My team helps pharma and life science companies with drug safety and compliance solutions, focused on scientific and medical side of pharma processes (Medical Affairs, Medical Information, Pharmacovigilance, Regulatory & Quality services). Our range of engagements varies from being an end-to-end solution provider to a strategic partner setting up and running the entire department (e.g. Pharmacovigilance) on behalf of our clients. Pharmacovigilance, or PV, is essential to ensure approved therapies can stay in the market to help patients. We support our clients and partners to bring better medicines to patients faster and thus pharmacovigilance is not just a service or side function for us, it is a strategic differentiator and part of our and our client’s success.
But it’s not easy. Teams and leaders are facing growing pressure on how to be as efficient as possible in tracking adverse events, and globally there are more and more regulations that companies must ensure they comply with.
The current process is complex and very cumbersome. Manual workflows lead to long turnaround times. Human errors in doing many of these tasks can put compliance at risk. As teams grow and make the therapy available to other parts of the world, with scale can come increased costs, more time and added risks. Plus, most PV teams work with multiple vendors across different functions, and it can lead to silos and inefficiency.
From these hurdles facing the industry was born the idea of EVERSANA ORCHESTRATE PV, an AI-propelled solution to deliver greater impact for our clients and simplify the drug safety management process.
PE: How was it conceptualized, and why?
Anand: As we were continuing to hear and see pain points in the industry, we knew we needed to innovate to meet the market needs. We looked over the course of several years at how we could optimize several common functions in drug safety through the power of AI.
Our team determined two big areas we could address through technology and partnerships that are major pain points for the industry––literature monitoring and aggregate authoring, and we got to work.
First, we needed a foundation for everything to live on – that was EVERSANA ORCHESTRATE, which serves as an AI powered backbone operating system for all EVERSANA systems. Think of it like iOS on an iPhone.
We then began to assess internal capabilities with our global team of experts, plus look outside at partners. This comprehensive approach helps us develop this solution that the industry desperately needs, and EVERASNA ORCHESTRATE PV was built.
PE: You note a partnership with the tech company Quantiphi, how did that come about?
Anand: As we looked for the right partner to help build a literature monitoring platform and really harness the power of AI in a highly regulated industry that understands both tech and drug safety, we looked at several vendors.
Quantiphi rose to the top given their depth of experience, especially in large language models.
PE: What’s the value of this new system to the drug safety industry?
Anand: It’s about speed, efficiency, accuracy, and scalability, all while meeting critical industry standards and putting patients first.
We knew the tools existed, but if we could just put the pieces together, we’d be in a great place. We challenged our teams, and they met this challenge. Innovation is part of our DNA at EVERSANA, and I'm so proud of this first phase we’ve build.
PE: This first version includes a literature monitoring function and an aggregate report creator for governing bodies like the FDA. Can you talk a bit about why these were the first processes that were identified?
Anand: Absolutely. These two functions––literature monitoring and aggregate reporting – are two of the biggest pain points facing the industry. There are literally thousands of adverse events reported in the published scientific literature in medical journals that becomes super complex for PV experts to find relevant data without having to manually comb through those articles by reading them word to word. Not just that, it extracts data from the full text article and auto-populates that data accurately into 150+ fields of the safety database. This saves a considerable amount of time for a case processor for the task that is considered one of the most complex and time consuming in the entire case processing cycle.
Our platform monitors all leading published scientific literature databases five times faster than anything on the market with 99.8 percent accuracy. This is what Quantiphi really helped us build. It seamlessly integrates into Oracle Argus Cloud, PubMed, Embase, and other known drug safety literature platforms, creating unification across all processes. It’s a gamechanger for this part of drug safety.
EVERSANA ORCHESTRATE PV aggregate authoring and reporting on the other hand helps efficiently generate reports needed for regulatory requirements such as the Periodic Adverse Drug Experience Report (PADER). It automates scheduling by automatically creating a calendar, generates the draft in a ‘ready for review state by PV experts and integrates seamlessly with eCTD platforms for electronic reporting to regulators, thereby saving on an average 90% of the time spent on the previous manual process. Through the power of AI, it almost eliminates the chances of error and ensures overall 99% accuracy, ready for the final review by a human.
This is what the industry needs as resources are stretched, but quality cannot be compromised.
PE: Does your team have additional modules planned for the future of the tool?
Anand: This is just phase one. We have a full roadmap in place for more functionalities in the year ahead to help address other complex time-consuming tasks that AI can help automate. These include the addition of more complex aggregate reports for different regulatory authorities like EMA, MHRA and other agencies. On the case processing front, the roadmap is set to deliver data extraction from structured and unstructured forms which is in fact a less complex scenario than the current use case of literature case processing that this platform already addresses.
It’s an exciting time for our team to be at the forefront of this innovation – really help propel the next generation of pharmacovigilance tools for the industry.
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