Discover the Key to Smart Pharmacovigilance

Today’s PV function has evolved into a corporate asset that boosts brand value and creates new growth opportunities because of various trends in global healthcare. However, maintaining the current safety systems is quite expensive.

Pharmaceutical and biopharmaceutical businesses are under intense pressure to reduce case processing costs while maintaining high regulatory compliance and raising the safety profile of their products through proactive signal identification.

Regulatory requirements force pharmaceutical and biopharma businesses to create a pharmacovigilance/drug safety surveillance program and keep an eye on the safety profiles of their marketed products during the whole product lifetime.

To facilitate proactive identification and prediction of safety signals and benefit-risk evaluation for marketed medicines, businesses are increasingly focusing on reorganizing drug safety and risk management programs. These organizations are also combining data sets across all stakeholders (pharmaceutical companies, regulatory authorities, patients) to foster complete transparency, sharing, and partnership. 

The industry processes and notifies local regulatory authorities of adverse occurrences using a variety of safety databases, such as Oracle Argus, ARIS-G, etc.

Transformation to smart case processing is required

1. The need for pharmaceutical companies to deploy and maintain more complex PV systems and manage safety surveillance activities is growing because of the changing regulatory environment and increased regulatory scrutiny, increasing disease complexity and the number of drugs getting approved, and growing awareness among patients and providers about reporting adverse events, social media connectivity resulting in a huge influx of data, and multiple templates or formats. 
2. Given the shortage of safety talent compared to demand and the pressure on businesses to cut expenses associated with manual case processing because of the rising number of adverse occurrences, it is urgent to review the old manual methods of case processing. 

Switching to adaptive case processing is required

• The need for pharmaceutical companies to deploy and maintain more complex PV systems and manage safety surveillance activities is growing because of the changing regulatory environment and increased regulatory scrutiny, increasing disease complexity and the number of drugs getting approved, and growing awareness among patients and providers about reporting adverse events, social media connectivity resulting in a huge influx of data, and multiple templates or formats. 
• Due to the lack of safety talent compared to demand and the pressure on businesses to reduce expenses associated with manual case processing because of the rising number of adverse occurrences, it is urgent to review the old manual methods of case processing.

Case Processing Automation: Methods and Advantages

• A typical roadmap for implementing an automation strategy would begin with process mapping and assessment to drive process improvements, make end-to-end case processing superior and leaner, and eliminate repetitive steps in existing processes.
• Artificial intelligence technologies can be used to transform the way pharmacovigilance case processing is done, making it smarter at every stage with less need for human intervention. These technologies range from basic automation through robotic process automation to cognitive automation with natural language processing, and finally taking to machine learning. 
• Although there are accessible cloud-based technologies, such as Oracle Argus, ARIS-G, etc., that automate case processing and reporting tasks, the process still necessitates a significant amount of manual labor during case intake and data entry. These operations are great candidates for automation utilizing RPA/AI technologies through the detection of patterns in unstructured data since they are rules-based, repeating, and generalized.
• Automation of the entire process from case receipt to reporting can limit manual intervention to specific activities like handling exceptions, quality assurance, and medical review.
• With the combined expertise of pharmacovigilance domain experts, data scientists, and IT engineers, standardization and automation strategies for PV processes have the potential to increase case process efficiency, leading to a significant cost reduction. They can also decrease manual errors, improve the quality of the deliverables, and guarantee regulatory compliance due to faster turnaround times. 
• Through a clear vision, well-defined strategies, and implementation plans with mileposts to monitor progress at each stage and metrics to monitor effectiveness and benefits, the adoption of these novel technologies can therefore add a new level of speed and intelligence to the pharmacovigilance process.
• Businesses that recognize the value of incorporating these cutting-edge disruptive technologies and utilizing them will fundamentally change the landscape of drug safety, be more effective in managing the increasing case volumes with better quality, and ultimately comply with the regulatory requirements related to the safety surveillance of their products.

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