Clinical supply outsourcing, the past and the future
Traditionally, outsourcing was only relevant to non-core functions within the clinical space. However, in the past decade, outsourcing central operations such as manufacturing and research have began to rise as many pharma businesses are strategically shifting their resources to leverage on external expertise and improve their core competencies. Through outsourcing, pharmaceutical companies are able to capitalise in multiple areas, we have highlighted a couple below:
· Reduced risk
Every day, there are thousands of drugs on trial all over the world, a high proportion will be rejected and a small number will see the shelves. Ultimately, pharmaceutical companies won’t want to risk investing funds into research which could have a potential yield of 0. Instead, by outsourcing, companies are able to ‘spread their eggs’, meaning if the research falls through, the pharmaceutical companies will still benefit as the costs would be significantly less than doing it themselves.
· Specialist knowledge
Through outsourcing, pharma companies can utilise knowledge from their partners, as continuous innovation alters the market, staff within the company may not be as educated as those in the partnering company. Consequently, the pharma business doesn’t have to invest money into the technology and waste time educating their staff, thus reducing costs and enhancing timeliness.
Although there are numerous benefits for pharmaceutical companies to outsource, there are several concerns for regulators, which has led to the amendment of ICH GCP E6; covering 3 main areas (data management, sponsor and investigator opportunity), this update will be the biggest revision in 20 years, which is likely to transform how clinical research is managed.
In conclusion, the new amendment will impact many pharma companies, as they have to be accountable for the vendor’s mistakes. Does this mean we will see a fall in clinical supply outsourcing?
Join us at this year’s Clinical Trial Supply East Coast conference as we delve into this pressing topic and explore the practical challenges of outsourcing, as well as other issues surrounding the clinical space today. We look forward to seeing you in Princeton!
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