One of the primary PDS differentiators is that customers usually entrust it with the complete study build, often as a result of limited in-house staff to address the task, says Hume. "These companies tend to have no legacy infrastructures and therefore jump right to EDC. They also have fewer change management issues that come with size and bureaucracy."
Its application service provider-based offering is surrounded by a host of additional services to ensure that clients get all the benefits of PDS technology, even if they don't have in-house EDC expertise and IT support. "We're still at the point where it usually makes sense for PDS to have a large services role in building studies," says Hume. "Many clinical operations groups don't have much experience with capabilities like morphing forms [that change as data is entered], and they may not think to take advantage of things like cross-form edit checks [on data gathered earlier or imported from other sources] when designing their eCRFs [electronic case report forms]. We help them exploit the technology to the utmost." PDS Express also generates some safety reports and alerts for severe adverse events. Up-front planning and design helps to prevent changes that cause timelines to slide. It's vital with adaptive trials where, ideally, all changes are pre-meditated.
In the future, more studies will focus on post-approval safety surveillance, predicts Hume. "I'm not sure how fast we'll implement these capabilities at PDS. We can do safety monitoring now [focused on Phase I - III clinical trials], but do we need to do more? Do we need a separate system to allow customers to have a more formal safety system applicable across all studies? We're watching this trend closely."
Deborah Borfitz is a Vero Beach, Fla.-based freelance writer who previously contributed to the clinical trials publication CenterWatch. She is co-author of Informed Consent, covering the risks and benefits of volunteering for trials.