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Outsourcing


efficiency.” Once the benefits were realised and the world became more globalised after the end of the Cold War, more and more central labs were set up across Europe and North America, and shortly after in the Asia-Pacific region – where many companies look to for partners due to lower costs.


“The speed at which samples are tested and collected are big factors. Lots of companies and hospitals have big problems with couriers not turning up, the wrong paperwork being filed, and, of course, Brexit has [had] an impact on this and the increased cost of petrol has pushed up costs a lot too.”


Christina Hamilton A critical partnership


Of course, picking which central lab to partner with isn’t as simple as it sounds. “Choosing the right partner requires several criteria, including working with a group that understands your objectives, can meet your timelines with the correct cost and quality, and will think critically about what you are asking them to do, and push back if it doesn’t make sense,” Lehner explains. One marker of competence among central labs is accreditation. In the UK, for instance, the United Kingdom Accreditation Service (UKAS) assesses the testing, calibration, sampling and measurement services performed by labs to ensure


they operate at the highest possible standards. Outside of accreditation, Lehner emphasises looking for a solid reputation and track record of working with industry partners. “This is important, especially over the past three years when so many labs struggled to maintain supply and personnel,” she says. “We are looking for partners and collaborators for our work, so reputation and references matter.”


Global problems


Reputation and services offered by a lab aren’t the only things that clinical trials operators need to take into consideration when choosing which central lab to partner with – especially as economic circumstances have placed a heavier emphasis on cost. “Costs and timelines are crucial when picking which lab to partner with,” says Christina Hamilton, senior CRA at Caritas Science Solutions. “Bigger companies can afford to use central labs more, but at the same time, smaller companies need to outsource to central labs as they do not have their own labs. The speed at which samples are tested and collected are big factors. Lots of companies and hospitals have big problems with couriers not turning up, the wrong paperwork being filed, and, of course, Brexit has [had] an impact on this and the increased cost of petrol has pushed up costs a lot too.” As well as trial specific capabilities, data handling and reporting can also play a key role in choosing a lab with which to partner. “Some sponsors need real-time results transferred daily into their online tools,” says Lehner. “Others are fine with set transfer timelines and may not see data for a long period of


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Clinical Trials Insight / www.worldpharmaceuticals.net


XXX/Shutterstock.com


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