Best Practices for Operational Alignment in Decentralized Trials

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: As trials become more decentralized and data sources multiply, what best practices can ensure operational alignment and regulatory compliance throughout the trial lifecycle?

Wilson: Yeah, so I think again, unified data management platforms, that's probably number one, establishing clear SOPs and training, again, between sponsor and supply chain companies, making sure that the teams are highly aligned. Another thing that may seem tactical, but it's super important, is creating clear governance and escalation pathways. I think, again, this is something that I really want to double click on, that as an important component of a collaboration between again, sponsor and supply chain partner.