Impact of Digital Transformation on Pharmacovigilance Efficiency and Accuracy

Gurpreet engaged in a conversation with Thiruamuthan, Corresponsent, India Pharma Outlook magazine in order to shed light on the ways in which pharmacovigilance outsourcing is undergoing pivotal transformation. He is based in UK and has a total of 18 years' experience in Pharma Industry of which 16+ years have been in Global Drug Development. During these years he has had the opportunity to work with some top Global companies like Cognizant, Tata Consultancy, Novartis and Parexel. Through these extensive years of experience, he has become a strategic thinker with expertise in Project Management, Six Sigma, and Digital Transformation.

How is digital transformation impacting the efficiency and accuracy of pharmacovigilance outsourcing?   

If you look at the pharmacovigilance industry globally, and specifically in India, it has been growing significantly over the last 15 years. Earlier, we used to receive paper cases that came in through fax and were entered into a safety database, which was finally submitted for the approval of authorities. In the last 15 years, there has been a tremendous change in the processes as to how pharmacovigilance is done. Not only has the sector come up with safety databases where processes can be operated in a paperless environment, but it has also been able to process information much faster and with better quality and efficiency. Specifically, in the last five years, there has been a lot of focus on technologies like Robotic Process Automation (RPA), Machine Learning (ML), Artificial Intelligence (AI), and now we are also discussing concepts like how solutions on integrated safety can be developed. In this, a pharmaceutical company will not have to work with multiple service providers to manage technology and services, but only one provider which can handle all the technology aspects related to safety and also take care of the services. This transformation has taken place in the last five years, and it will continue to happen. 

Please elaborate on the role of artificial intelligence and machine learning in modernizing pharmacovigilance processes within outsourced services.

Gone are those days when pharmaceutical companies used to look at service providers solely for case processing or report aggregation. Now, when a pharmaceutical company wants to outsource work, they look at the capabilities that the service provider has in terms of technological innovations like AI, ML, and others. One aspect that many technology companies are focusing on is how they can develop a safety database with built-in automation solutions. For example, e2b cases are being processed without human intervention, with the workforce only required to ensure the quality of the cases. This is referred to as augmented AI, where systems carry out processes with human supervision. There is also the aspect of text-less QC, wherein any project requiring QC is evaluated to determine how much can be automated without human intervention. Augmented AI plays a vital role in pharmacovigilance outsourcing, as AI systems are trained to analyze years of collected data and detect adverse event occurrences. The industry aims to delegate mundane and repetitive tasks to these systems while utilizing human intelligence for supervision and decision-making.   

What are the key regulatory challenges faced in pharmacovigilance outsourcing today, and how are providers adapting to these changes?

In terms of regulatory changes, they have become more focused on patient safety in the past 15 years. Regulators are interested in ensuring that every company has a strong pharmacovigilance system that ensures patient safety is never compromised. This ensures that all pharmaceutical companies are implementing the right pharmacovigilance systems, and whenever there is an update in regulations that is in the interest of patient safety, the companies are required to update their PV systems accordingly in a timely fashion. From a process perspective, the regulatory guidelines in the pharmacovigilance industry have also evolved. There are now standard processes to check the quality and compliance in pharmacovigilance systems that were not there earlier. Companies are looking to make their pharmacovigilance processes more efficient in order to stay compliant with regulatory requirements.

How is the globalization of clinical trials influencing the strategies of pharmacovigilance outsourcing companies?

The pharmacovigilance industry is around 7.3 Bn as of 2023 and is expected to grow at a CAGR of around 7 percent in the coming decade. By the end of the decade, we expect the pharmacovigilance industry to be about 12 billion dollars. Many pharmaceutical companies are investing in new products, and there are numerous innovative drugs coming out in the market. This creates a need for effective pharmacovigilance of these drugs. At the same time, there has been a lot of activity in the mergers and acquisitions space.