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Against a backdrop of stringent safety requirements and rising cost pressures, global drug safety groups within pharma companies are keenly looking on delivering 'more with less' and refocusing their efforts on what is considered as 'core'.
Traditionally, drug safety groups have operated as drug safety factories, which incurred significant capital expenses in building infrastructure related to technology, processes, people and other operational investments. Technology solution providers also built systems that were licensed to sponsor companies, where internal IT infrastructure groups managed these applications and safety databases. The rapid evolution of the Internet in the late 1990s has changed the business landscape. Although pharma was a little late to adapt to this changing technology, the concept of outsourcing became prevalent. During 2000-2010, global pharma companies spent significant time and effort to outsource several key aspects of drug safety operations. This transition in methodology also forced drug safety database vendors to develop newer models of solution platforms. Software as a Service (SaaS), with superior and secure cloud-based technology spread rapidly to drug safety organisations. Pay-as-you-go models started to evolve. The mind set of 'price per case' was beginning to get discussed in conference rooms more often and marked a paradigm shift for drug safety groups, where refocus happened. Drug safety groups started to emphasise their time and resources on risk management, signal detection, and emerging markets; less was spent on drug safety operational issues, technology investments, and running the factories.
Nostrapharmus predicts that during the next 5-10 years, drug safety operations will become almost completely commoditised. Sponsor companies will demand transactional pricings from their vendors. Vendors will, in turn, benefit from higher case volumes through new media such as social networks, mobile smart phones, emerging nations, and a more aware and educated public who will recognise drug safety issues in a comprehensive manner. The age-old challenge of under-reporting of adverse drug reactions will improve. There will be higher case volumes to be managed. Clearly, technology vendors will further enhance their solutions and offering and become more 'utility' companies than software or technology providers.
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The Drug Safety Utility.pdf
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