Six-Month eCOA Timelines Signal Need for Earlier Planning

Christy Owings, vice president and general manager of the Americas business unit, Thermo Fisher Scientific, connected with PharmTech to discuss how early collaboration between sponsors and clinical supply partners can prevent late-stage bottlenecks.

Owings points to electronic clinical outcome assessment (eCOA) planning as a common gap in early-stage protocols. Sponsors often finalize a clinical protocol and supply chain concept before fully addressing elements such as eCOA licensing and translation requirements, which can take roughly six months to develop and launch. In competitive trial environments, that timeline matters: sites and patients are often drawn to the usability of an electronic outcomes solution over a paper-based alternative.

"It becomes then a bit of a thought partnership as opposed to trying to accelerate for items that we could have identified earlier in the protocol creation process," Owings says, describing the value of engaging a clinical supply partner earlier in trial design.

Owings also emphasized the importance of sponsors physically visiting the sites within their supply chain, not just primary drug product fill-finish or clinical packaging and labeling facilities, but depot network sites as well.

"There's so much that you can gain from partnerships and relationships across your vendor sites, across your CDMO partner," Owings says.

Her guidance underscores a broader theme in clinical supply chain management: proactive engagement and direct site relationships can help sponsors avoid downstream delays and build confidence in both the supply plan and the people executing it.