PV service providers help in collection, detection, assessment, monitoring, prevention of adverse effects in pharma products; players like Cognizant, Accenture, TAKE Solutions, Oviya MedSafe buzzing with activity

The Covid-19 pandemic has increased the demand for pharmacovigilance (PV) services from technology solution providers to help global pharma companies develop drugs to fight coronavirus.

Companies like Cognizant, Accenture and boutique players like TAKE Solutions and Oviya MedSafe have been quite busy since March providing increased PV-related services to global clients.

PV is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. It is vital for the development of new medicinal products.

The global PV market is expected to nearly triple to $12 billion by 2027 with the rapid growth attributed to a rise in application for spontaneous reporting, electronic health record mining, cohort event monitoring and intensified adverse drug reaction reporting, according to a recent analysis by Emergen Research.

A significant portion of the PV services is outsourced. However, there is no data on the size of the market, said industry sources.

Sairamkumar Jayaraman, Head of Delivery for Healthcare and Life Sciences, Cognizant, said Covid-19 has increased focus on safety operations due to rapidly-growing investments in clinical trials for various Covid-19 treatments (vaccines, antivirals and convalescent plasma).

PV is a highly regulated industry that requires 100 per cent quality and compliance with on-time submission of expedited and aggregate reports to global regulatory agencies. “We monitor guidance and changes to regulations issued by major global regulatory bodies, and advise our clients on the impact of those changes on their business processes,” he said.

Agreeing with Jayaraman, Mahesh Zurale, Senior Managing Director, Lead - Advanced Technology Centres in India, Accenture, said that the Covid-19 pandemic has heightened the need for pharma companies to leverage advanced technology and digital capabilities to expedite their clinical trials.

According to J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe Pvt Ltd, Covid-19 has created lots of demand for PV services in clinical trials. This is because a number of studies have been initiated to evaluate therapeutical options for the pandemic and safety monitoring in non-Covid-19 trials has become more challenging due to the pandemic. The expectation for innovative tech-based initiatives to monitor the safety of clinical trial participants has gone up.

PV in post-approval stages has faced different sets of challenges with numerous reports of Covid-19 infection reported as adverse events in relation to medicinal products taken by patients for non-Covid-19 indications. This has increased the workload, and strong PV expertise is required to assess the ‘noise vs signal’ ratio from such huge numbers of reports received within a short while. Technology has lent an effective helping hand and PV is becoming more relevant than ever in such a scenario when everyone is eager to get a vaccine/cure for the pandemic, he said.

“As newer diseases or disease groups come, we become more and more relevant. We are already doing six Covid-19 trials for five clients,” said HR Srinivasan, Vice Chairman & Managing Director, of Chennai-based TAKE Solutions.

According to Boz Hristov, Professional Services Senior Analyst, Technology Business Research, regulations create initial disruptions, likely requiring upfront investments, but also long-term opportunities.



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