It has never been clearer that eSource – the process of capturing clinical source data through an electronic application, rather than on paper – is the future of clinical research. Several years after the FDA released its eSource guidance, the EMA has now begun to signal an openness to eSource in the qualification opinion released late last year, clearing the way for an eSource revolution on both sides of the Atlantic. They’re not alone: numerous success stories from researchers in the Asia Pacific region, including some Medrio customers, show the potential for direct data capture (DDC) through eSource to streamline and enhance clinical trial processes worldwide.
Against this backdrop, Medrio has released a number of key upgrades to Medrio DDC, one of the three applications in our eSource suite. These upgrades all emanate from a common goal: to streamline site workflows with our direct data capture application in ways that benefit the entire clinical trial. Learn more about Medrio DDC and our other products here. In the meantime, let’s take an inside look at the new release, and the latest steps in our journey to accelerate data entry, reduce costs, and improve data quality starting at the site level.
Never miss an open query
Nothing is more important in a clinical trial than data accuracy. It can have major implications for both patient safety and product viability. From the beginning, Medrio’s real-time edit checks have fired queries automatically for missing or out-of-range data. With our new upgrades, Medrio DDC alerts you to any queries that remain open before you even leave the patient’s bedside. Users will notice a red dot next to subject ID for any patients that have open queries associated with their records. Getting alerted to open queries while patients are still on site can accelerate query resolution and improve data accuracy.
Validate before you update
Our human-centric philosophy keeps us consistently focused on the customer experience. We understand that software upgrades can seem to come out of the blue, with users being asked to implement them before they, or their processes, are ready. Our Medrio DDC upgrade brings users a new Validation Environment App that lets you try out new features before updating your tablet’s production environment to the latest version. This enables you to maintain compliance and mitigate risk to your study – by testing out new features in a sandbox environment before you deploy them live.
A crucial backup for continued efficiency
Thanks to the full integration of all of Medrio’s products, Medrio DDC syncs all entered data directly to our EDC at the touch of a button. But even the most airtight systems need a failsafe when something as sensitive as clinical data is on the line. That’s why we’re now providing the option, in the rare event of hitting a snag in the sync process, to export data from Medrio DDC to a CSV and upload to our EDC from there. A typical use case for this would be when a mid-study change is deployed while there’s still data in Medrio DDC that the user hasn’t synced yet. Instead of transcribing this data into the EDC, the export function allows for a quick and easy sync-up of outstanding data.
Field-level audit trail
For our animal health customers, we’ve implemented the field-level audit trail, which allows CVM-regulated animal health studies to track all actions to variables, such as additions, updates, and deletions, before saving the forms according to regulatory guidance. Each time a user updates a variable’s value on a form, a reason for the change is required. For studies outside the animal health space, keeping a field-level audit trail isn’t necessary – a form-level audit trail will suffice. To turn on the field-level audit trail, reach out to your Medrio account manager.
With our new updates to Medrio DDC, our customers will be better equipped than ever to protect patients, strengthen regulatory compliance, and keep their workflows streamlined. The upgrades represent the latest step in our campaign to move the eSource revolution forward.