Logistics
affect clinical trials, as we properly forecasted and had buffers in-house for these supplies.”
Ancillary supplies can mean anything from test tubes that store biological material to the lab equipment used to conduct tests on it.
were being shipped out of the country because they wanted to hold them for their populations,” he recalls. In addition, many non-qualified suppliers started popping up. “We ended up with many fake suppliers in the market; everybody was getting into panic mode.”
Even with governments doing their best to regulate prices, costs went through the roof and sponsors were put in situations where they only had hours to decide whether to buy a certain item or not. If you called back a minute too late, Vyas remembers, the material would be gone. “It was a nightmare,” he says.
“The processes to source, receive, release, and clinically label these ancillaries has been more complex and has sometimes required the development of new operating procedures.”
Aaron Steinbrecher 7 Parexel 28
At biopharmaceutical company AbbVie, the expansion into more and more therapeutic areas over the years has meant their processes have had to adjust to accommodate new and unique ancillaries, including materials used in on-body delivery devices such as pumps, tubing and vial adapters. “The processes to source, receive, release, and clinically label these ancillaries has been more complex and has sometimes required the development of new operating procedures,” says clinical supply project manager Aaron Steinbrecher.
Parexel’s clinical distribution depots around the world, stocking more than 3,000 different ancillary line items.
The main negative impact of supply chain issues and higher demand for products was longer lead times on some of the standard ancillaries they use, such as syringes and IV bags. In addition, many clinical site personnel couldn’t physically get to clinical sites. “Lead times were anywhere between a few weeks to a few months,” Steinbrecher says. “But this did not
Lessons learned from the pandemic If there was one benefit to come out of the pandemic for CROs and clinical supply managers, it was the strengthening of sourcing procedures. Parexel already had a robust set of qualified suppliers and a sizeable amount of stock sitting in their depots. But proactive stocking and keeping a minimum level of often-used items became even more important. “We always conduct studies in certain therapy areas, and we know that these are the standard materials that are always required,” says Vyas. “We’ve also started taking a more holistic view, looking at how we can utilise these ancillary supplies across different studies. With IMPs, you can’t do that because it’s always specific for a therapy, but with ancillaries, it’s possible to cross-pollinate.” More importantly, he and his team learned just how crucial it is to have a seat at the table right at the planning stages of any clinical trial. “The sponsors could have done everything right. They could have set up remote monitoring and direct-to-patient procedures, but what if the material didn’t turn up? It would all be useless. [It’s ideal to] be part of a protocol design even to the extent where we have influence when they are selecting the sites, but that doesn’t happen all the time,” he says.
Steinbrecher agrees that, depending on the type of ancillary, the lead time to source, deliver and quality release can vary widely, so understanding these timelines upfront is crucial to be able to start the study on time. As a trial goes on – and evolves – however, he says it’s important to be flexible. “One of the biggest lessons we’ve learned is to set up our clinical trials with as much flexibility as the study design will allow when it comes to sourcing ancillaries,” he explains. AbbVie uses planning and forecasting tools that are integrated with their packaging and inventory systems, so they know exactly what they will need to source – not just now, but for the future and in anticipation of new trials down the line. “These tools are integrated with packaging and inventory and have the capability to forecast for the entire length of a study,” says Steinbrecher. “We use them in the beginning stages of study planning, and they have the ability to be updated as study needs change.” The pandemic is far from over and new travel restrictions continue to be implemented at increasingly short notice. Ancillary sourcing certainly isn’t going to become any less complex in the near future. But the lessons learnt from Covid-19 so far may be able to help sponsors and CROs build a stronger foundation on which to operate. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Roman Zaiets/
Shutterstock.com
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