PRISYM ID Blog Are You Label Ready?

Q1). WHAT'S HAPPENED IN THE LAST COUPLE OF YEARS IN THE CLINICAL TRIAL SECTOR? Simon Jones: It's been a challenging two years with quite a lot of change - mostly driven by the pandemic which put additional demands on the industry. As a result, the clinical trial industry pulled together in response to the need to produce vaccinations and support clinical trials that were already underway, where patient safety remained critical during periods of lockdown. However, it's not just Covid-19 that has caused challenges over the last couple of years. Another catalyst for the change has been the significant uptake in biologics trials, in terms of volume and geographical reach. The accompanying cost to manufacture clinical trial medication and source comparators may require changes to traditional supply models. Another thing that our customers have found challenging is continuing regulatory changes. Of which the most significant has been the introduction of EU clinical trial regulations which has influenced how clinical trial supplies are being handled. Bob Bowdish: Covid showed us what is possible in terms of shorter clinical development timelines. Sponsors are choosing service providers that can help them reduce the number of parties involved in the trial process. CDMOs are responding by adding additional service lines. Q2) HOW HAS THE INDUSTRY RESPONDED TO THESE CHALLENGES? Simon Jones: It's been tough, but the industry has performed very well thanks to a significant level of collaboration between pharma sponsors and their service provider partners, and I think the changes that we see here have also had an impact on how packaging and labeling have been performed. The drive to perform Covid vaccination trials quickly led to a step-change in terms of the need for trials to be faster and more adaptable. The last couple of years have seen a big change in the growth of adaptive clinical trials and industry initiatives like decentralized clinical trials have come into their own. Additionally, it was clear that sponsors both collaborated more and relied upon their service provider partners more than ever before. As a result, we're now seeing a level of transformation amongst those service providers where they are looking to standardize or operationalize some specific supply chain initiatives that they may have put in, in response to the pandemic and which they now want to keep. Bob Bowdish: Covid, lockdowns and patient safety concerns put existing clinical trials at risk. Sponsors began leveraging service providers to utilize direct-to-patient supply for the first time. One large biologic sponsor literally picked up the phone and called shipping companies that could come pick up kits and take them to patient's homes. Another rare disease sponsor had only one patient in a country and had to make arrangements to get kits to them. Also, supply chain issues such as shortages with glass vials or sourcing comparators required sponsors to reach out to service providers that they had not worked with in the past. People were quite resourceful The post Are You Label Ready? first appeared on PRISYM ID.