Outsourcing non-critical processes constitutes normal day-to-day business and best practice in industries like Aerospace, Automotive and Telecommunications. Losing the non-value add stuff so that more time and budget is available to spend on the critical? A no-brainer, surely? But this is not yet the case in Pharma, an industry that transforms our lives with modern science, but whose approach to business processes can sometimes be a little lacklustre by comparison.
Outsourcing is not a new concept to pharma per se. Manufacturing capacity and clinical trials are frequently outsourced; and truck loads of documents and paperwork are shipped to Clinical Research Organisations (CROs) on a regular basis. But outsourcing an actual compliance critical process? No way. Take for example Pharmacovigilance; the terror of being sued over incorrect reporting of an adverse event, or putting the business reputation at risk has led the Pharma industry to clutch these processes fearfully to their chest. The processes themselves are needed for compliance reasons and add little in terms of value, but plenty in terms of cost and added stress to the business.
So is it plain foolishness, stubbornness, the fear factor or all three that make Pharmacos ignore the benefits that outsourcing can bring? Well, intense scrutiny and regulatory pressures mean that a culture of extreme caution has developed when it comes to new ways of working.
Many processes in Pharmacovigilance are a burden to Pharma and ripe for outsourcing. In a business making drugs based on, for example, acetylsalicylic acid, a product that has been on the market for well over 100 years, the chances are there is often no new knowledge to be gained from PSURs and single case handling, yet the dogged reporting and analysis still has to take place in order to maintain compliance. The drugs do not contain intellectual property, do not tell the company anything useful and could easily be managed outside of the business. Forward thinking Pharmacos are beginning to wake up to this fact.
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