Cognizant has announced a recent report issued by Everest Group ranks its pharmacovigilance services among the best-rated in the industry. The report evaluated 22 pharmacovigilance service providers, and respondents’ collective ratings put Cognizant at the top of the list.
Outsourcing-Pharma recently spoke with Srinivas Shankar, Cognizant’s global head of life sciences, about the firm’s pharmacovigilance services, and the ways the overall field has evolved in recent years.
OSP: Could you please talk about the evolution of pharmacovigilance practices and technology?
SS: The practice of safety and pharmacovigilance started in the 1960s and has grown into a critical and strategic business driver. Not only do organizations collect, analyze and report drug safety data to regulatory bodies, they also leverage real-world evidence to enhance the safety profiles of their products as a key competitive advantage.
In terms of technology, organizations began managing pharmacovigilance data by building custom software, and software vendors followed suit with targeted product offerings. As the amount of data from pharmacovigilance has grown, organizations have turned to companies like Cognizant to help collect, analyze and report case data.
In addition to operations support, we have helped our customers modernize their technology, move to cloud-based or SaaS models, and provision smarter and more modern platforms that can automate intake and case processing and reduce the overall effort and time required. We were one of few in the industry to develop a regulatory-approved bot to assist with global case processing and compliance where we automated case intake, which reduces human error while increasing speed and quality.
In the past few years, we have been leveraging new technologies (artificial intelligence, machine learning, and natural language processing), to transform existing systems. AI solutions work best when paired with human intelligence to aid and augment decision-making rather than replace.
Case processing alone can traditionally take up to 80% of overall efforts, and we’ve worked with partners and other organizations to implement intelligent automation solutions that reduce time by 30-60%. As a result, sponsors have been able to improve the speed, quality, and compliance of these processes at a reduced cost.
We’ve also helped customers bring in data from electronic health records, electronic medical records, social media, and patient advocacy organizations. We’ve helped them modernize their approach to be able to process more volumes of data, from more diverse sources while continuing to comply with requirements.
Looking forward, we are leading the industry towards a future of “touchless case processing,” where bots will be able to read data from structured and unstructured channels and automate manual tasks like opening and scanning PDFs, performing character recognition, extracting information, translating multiple languages, and standardizing data into a format that can be read by humans. In some cases, technology may be able to perform some of the data analyses so they can be directly submitted to regulators.
OSP: Please share how shifting pharma industry conditions and client demands have impacted the pharmacovigilance field and providers in that sphere.
SS: I’d like to share four trends affecting how biopharmaceutical and medical device companies are moving beyond simple compliance in order to drive business value by leveraging their pharmacovigilance operations:
Adverse events continue to rise in volume as well as across geographies. For example, from 2014 to 2019, the number of adverse events reported to the US Food and Drug Administration (FDA) increased by 91%. This illustrates the need to reimagine ineffective processes and technology.
In addition to higher data volumes, organizations are increasingly facing disruptive regulatory challenges, such as reporting across proliferating channels. The results are increased compliance costs. One estimate suggests costs are projected to increase by 7-9% annually through 2023.
To unlock value, organizations are continually seeking methods to integrate variable structured and unstructured data in order to realize higher value-added functions such as safety surveillance with risk minimization, predicting adverse events, and advancing personalized healthcare.
Finally, organizations are rightfully concerned with patient centricity—centering patient voice and need in all relevant processes. Practically this results in organizations exploring methods to more fully integrate patient data from real-world evidence into clinical trials, pharmacovigilance, and product development.
These factors are accelerating the shift to proactive risk management and driving demand for cognitive technologies that can improve adverse event case handling, unlock growth opportunities and scale compliance operations.
OSP: Let’s talk about the COVID-19 pandemic—how has that impacted the work of life-sciences professionals centered on pharmacovigilance?
SS: The COVID-19 pandemic intensified patient safety challenges and heightened the need for a digital ecosystem that supports activities like decentralized clinical trials, engaging patients remotely, and working collaboratively with traditional and nontraditional partners.
There were very few biopharmaceuticals and medical device companies that were prepared to go completely digital at the start of the pandemic. Even though all clinical trials initially came to a grinding halt, the industry quickly pivoted and accelerated the implementation of ongoing trends, such as decentralized clinical trials.
From a safety and pharmacovigilance standpoint, it's become essential to ensure patients can easily and safely report adverse events. Additionally, greater coordination across the safety management ecosystem has become paramount. Finally, sponsors need to continue implementing technologies that reduce human dependencies and interactions as much as possible.
OSP: How has the development of potential COVID-19 treatments and vaccines helped underscore the importance of diligent, informed pharmacovigilance efforts?
SS: The volume of treatments being repurposed, the speed of vaccine development, and the scale of distribution of the vaccines are increasing at unprecedented rates. In order to enable smart product development, manufacturing, and distribution speeds, we’ve been working closely with many life science organizations to assist with their research and development efforts and to potentially prepare for an onslaught of adverse event reports.
With any new treatment, you will see related and unrelated minor and serious adverse events. So, it’s important to quickly capture, process, and report potential safety issues.
Beyond the basics of monitoring drug safety, it’s vital that we use the data and technology at our disposal to predict potential serious adverse reactions and enable comprehensive drug safety profiles, which are important for patients who may be utilizing multiple therapies or managing multiple conditions. That’s where smart pharmacovigilance plays an integral role in enhancing the visibility of potential issues and preparing companies, regulators, NGOs, and affiliate organizations, such as county public health departments, to respond to issues quickly and with scientific reason.
OSP: Congratulations on the recognition from the Everest Group—what does this say about your firm and its work/services in this area?
SS: Cognizant is the industry’s pharmacovigilance services leader, and the Everest Group ranking recognizes the help, support, and advice we’ve provided during unprecedented global and industry shifts. It speaks to our talent, technology, and partnerships who continue to help us improve offerings for our customers. It also speaks to our vision for the future of pharmacovigilance where organizations can leverage technology to process data, predict potential events, prevent serious adverse drug reactions and enable personalization by correlating safety data with human genomics and personal health data.
OSP: Do you have anything to add, about this report, pharmacovigilance, AI and other advanced tech, automation, or other areas of Cognizant’s expertise?
SS: Cognizant and our people have been leading the way to drive digital transformation in healthcare and life sciences. We are investing in transformative initiatives like Decentralized Clinical Trials, Manufacturing 4.0, Internet of Medical Things (IoMT), and AI/ML/NLP-based automation through evolutionary learning platforms. All of these investments are helping us create roadmaps for the future in end-to-end clinical research and thus impacting Safety and Pharmacovigilance as well.
As a society, we seem to be on the cusp of a golden age of biotechnology. That’s why Cognizant continues to design technology with the patient at its core, with the goal to intelligently automate manual tasks, deploy smart analytics to inform and aid human intelligence and develop digital talent who can deliver outcomes through data and insights.
We’re also investing in the needs of our communities and in relationships with best-in-class partners to broaden our impact as we help address today’s challenges, all while looking toward the future when science and technology may be able to prevent disease before it starts and support the personalization of care when and where it's needed.