How Integrated Systems Help Biotechs Stay Inspection-Ready

In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for actionable data to meet aggressive timelines and budgets. Remote monitoring is crucial for quick decision-making and patient safety, reducing site burdens and leveraging advanced technology. Integrated systems help study sponsors meet evolving regulatory expectations by removing data silos and streamlining inspection processes. Barriers to real-time trial oversight include data silos and the need for integrated systems. Best practices for decentralized trials include unified data management, clear SOPs, and governance pathways to ensure operational alignment and regulatory compliance.

ACT: What role do integrated systems play in helping sponsors stay inspection-ready and meet evolving regulatory expectations?

Wilson: You mentioned regulatory. I think the market is changing rapidly in front of us. If you think about how data is captured, how data is managed within certain regions and even therapeutic areas, it’s really important that we remove some of those silos to enable data to be captured and logged in an appropriate way that then can be provided to the sponsor. We actually had a recent example with a customer, they were a small biotech, and they were about to have an FDA inspection, and they commented on how some of our teams at Thermo Fisher Scientific captured the data, how we provided it to them. It really helped streamline the process of that FDA inspection, and resulted in a very successful inspection for them, which is critical. You imagine biotechs, they've got to have partners who can enable them to be inspection ready to your question, and it's really important that we support them on that journey with our expertise within Thermo Fisher Scientific.