5 Questions for Your EDC Provider

Does a Mid-Study Change Require System Downtime?

This, unfortunately, is still the expectation for many new clients we speak to. Many EDC platforms require the system to be brought offline any time mid-study changes are pushed out. Most studies face at least a handful of mid-study changes, which are costly in time and resources, and a significant portion of this cost is directly attributable to the EDC provider’s capabilities with change management. Tufts reported a 20% Cycle Time Advantage to go Live Again among users that reported being satisfied with change management in their EDC.

Can Edit Checks, Dependencies, and Questions Reference Cross-Form Data?

Being able to reference cross-form and cross-patient data in the design of your casebooks and edit checks really opens up possibilities for trial design. Being restricted to referencing only data found within a single form places constraints on your casebook design forcing more data to be aggregated in single places. Users need the flexibility to store data where it should be, and to control role-based access to that information in a precise way. Cross-form reference capabilities give users the freedom to design their casebooks and databases in whatever way makes the most practical sense for the trial, rather than being guided by the limitations of their EDC.

Does the Platform Support Local Lab Ranges?

Gradual decentralization of clinical trials has rendered the use of diverse local labs commonplace. It is imperative that the system supports localized edit checks on lab ranges in a straightforward and convenient way. Any commonplace need for trials like this should be automated.

What Elements of Platform Functionality are Configurable? More Importantly, What is Not?

It’s uncommon, risky, and expensive to change your EDC in the middle of a study, but one of the most common causes we see from clients reaching out to us relates to configurability. Specifically, they either misunderstood or were misled about the degree to which elements of their current EDC could be adjusted to suit their specific needs. Every trial is different, a highly configurable system gives you the assurance that your technology can adapt to your needs now, and as they change. Customizable is not configurable. While customizable platforms are a step up from fixed, pre-configured tools, customizations cost time and money as you work with the vendor to implement your solution. An EDC that emphasizes configurability is a strong indicator that the software vendor is aware that there is no one-size-fits-all for trials, and understands that it is their responsibility to prioritize future-proofing that technology they provide for their clients.

Is the Company’s HelpDesk Outsourced?

It’s a simple question but it’s no secret that, increasingly, companies across all industries outsource human resource tasks where they can. Having a responsive, 24-hour HelpDesk staffed by internal employees that understand the software they support is an indispensable safety net. The best protection against unexpected circumstances is reliable and informed support from your partners.