pharmacovigilance Archives - Medical Design Sourcing

Investments in AI and ML help PV teams transform safety case processing

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Thanks to automation in pharmacovigilance, the next generation of safety is here — and with it, there is an immense opportunity for firms that can change how they work and maximize the opportunity automation creates.

Leading safety teams are seeing up to 80% efficiency gains on key workflows by investing in touchless case processing, automating pharmacovigilance processes across intake and assessment, review, full data entry, medical review, quality review and submission.

A new opportunity in AI and ML

The life sciences industry is rapidly growing in scale and complexity, with organizations generating increasingly large volumes of safety data. The pharmaceutical industry, healthcare providers and consumers have reported more than 18.6 million adverse events to the U.S. Food and Drug Administration (FDA) in the last 10 years, 216% more than the prior 10 years.

Safety case da…

Pharmacovigilance in personalized medicine: Adapting to a new era of drug development

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One of the ways that the COVID-19 pandemic had a profound impact on the pharma industry was how it highlighted the importance of pharmacovigilance. As personalized medicine gained traction, drug developers had to evolve their strategies to ensure safety and efficacy. In their report, “The Future of Pharmacovigilance,” Dr. Sabine Jeck-Thole and Ben Enejo, partners at Arthur D. Little, discussed the challenges and opportunities in this new landscape.

Embracing the shift in perception of adverse events and side effects

“When we heard about adverse events and side effects, it was not bad news,” Jeck-Thole said in an interview. “It indicated that we understood our drug or vaccine much better than without any safety information.” She emphasized that this shift in perception was essential for the industry as it moved towards pharmacovigilance in personal…

How automation is changing the face of pharmacovigilance

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The ever-growing volume of data from clinical trials, drug use and other sources presents both opportunities and challenges for pharmacovigilance. COVID-19 has presented an array of possibilities for pharmacovigilance service providers. Detecting and evaluating potential safety signals is essential to maintain the safety of drugs and other therapeutic products.

Companies are constantly challenged to keep costs down to optimize their investment, focus on patient safety and undertake benefit/risk analysis of products. The hard truth is that pharmacovigilance is an additional cost that doesn’t draw revenue but is an essential requirement to do business. The pharmaceutical industry has learned that pharmacovigilance is more than a business necessity. Pharmacovigilance can be an asset as it can inform discov…

A new era of pharmacovigilance: Worldwide master key for drug safety monitoring

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Pharmacovigilance is the backbone of pharmaceutical manufacturing. Without it, there would be no way to compare the efficacy of pharmaceuticals to their detrimental consequences. Pharmacovigilance, or PV, is intended to safeguard patients and enable the spread of knowledge among experts to reduce the risk of adverse events.

According to Future Market Insights, the global Pharmacovigilance market is anticipated to grow with a robust CAGR of 14% from 2022 to 2032. Rapid pharmacological advancement in drug discovery in recent years has resulted in the formation of several institutional-level research and development projects, culminating in clinical trials with highly decisive outcomes. Furthermore, increased hospital admissions for various disorders are forcing healthcare facilities to streamline their procedures. As a result, the scope of pharmacovigilance…

The future of pharmacovigilance: Assessing the role of ML, NLP and other technologies

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The field of pharmacovigilance has evolved significantly in recent years. While regulatory authorities have long favored technologies such as artificial intelligence and machine learning for monitoring patient safety, the trend has accelerated during the pandemic. “I’ve never seen as much advancement as I have in the last two years,” said Marie Flanagan, director, offering management, Vigilance Detect at IQVIA.

Flanagan predicted that regulators’ interest in AI and ML for pharmacovigilance will catalyze growing interest across the pharma industry in 2022 and beyond. The pandemic has demonstrated to regulators and life science companies that the technologies can help make sense of exploding volumes of pharmacovigilance data points.

“If we look at just the user vigilance database in the past two years — as of last week, 64% of all infor…

Automating audio records processing to manage surges in patient data

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The volume of audio files that potentially contain valuable data on adverse events (AEs) has exploded, outpacing the pace pharmacovigilance (PV) operations originally anticipated in the COVID era. Healthcare company call centers, which in some instances saw up to 75% of adverse drug reaction (ADR) notifications reported through this channel, are challenged to handle this drastic increase in source data that requires tedious review for potential safety events or risks contained in audio interactions and transcriptions. As the increase in source volumes surpasses normal hiring capabilities, pharmaceutical companies face a growing challenge to ensure compliance with AE reporting regulations.

The need for a technology solution

Anyone contacting a healthcare provider (HCP), healthcare regulator or a medical commercial call center could disclose potential adverse events (PA…