WHODrug B3 Updates and Beyond – How Our New Release Helps Our Customers

Finger on computer keyboard for new Medrio release

eClinical product development is an iterative process. There’s always potential to make an EDC platform faster and more flexible – to create new functionality that enables more intricate capabilities for the users. That’s why, at Medrio, we never stop looking for the next enhancement to our customers’ experience. It’s part of our strongest guiding principle: that our customers are out there chasing life-saving medical breakthroughs, and so it’s our duty to prioritize their needs and eClinical experience above all else.

With that in mind, we thought we’d offer an inside look at some of the items in our upcoming feature release, due this Saturday, March 16. All of these features were spurred either by customer requests, regulatory shifts in clinical research, or some combination of both.

WHODrug B3 enhancements

Last year we ran a blog post outlining the upcoming changes to WHODrug formats, explaining that although the new format requirements were still months away, it was a good time to get an early jump on preparations. With the requirements now upon us for new studies, we’ve done our part by updating our software and certifying it for compliance with WHODrug B3. The update will allow for a more comprehensive account of drug combinations and make it easier to identify the generic classification of name-brand drugs. It accounts for a broader increase, over the last 30 years or so, in the level of pharmaceutical consumption among clinical trial patients, as well as the differences in generic and brand naming conventions.

When our new release goes live, the B3 updates will be automatically enabled and available both for existing studies and studies provisioned after the release.

New filters for reports

With reporting functionality often cited as a source of frustration among EDC users across the industry, Medrio saw an opportunity to optimize our customers’ experience and make our already intuitive software even easier to use. Our upcoming release will roll out a new set of filters for our Standard and Build-Your-Own reports. These new filters have a multitude of advanced sorting capabilities, such as distinguishing between numbers and text, selecting ranges of variables, detecting empty fields, and more.

We developed these features in response to a number of feature requests we received from our customers – they asked, and, with this new release, we’re answering.

Field-level audit trail

The Center for Veterinary Medicine (CVM) is considering guidance requiring tracking of all actions to variables – including updates, additions, and deletions – with the time, reason, and author of each action recorded in the audit log. We’ve made the necessary upgrades to our system to proactively comply with this anticipated CVM guidance to keep our animal health customers in full regulatory compliance. Field-level audit trails will only be available for animal health studies – the new guidance can increase the burden for those entering data and that additional burden is not required for human trials.

Medrio, like most eClinical providers, works mostly in the human health space. But while other providers might be reluctant to expend much effort implementing changes that don’t touch the human health sector, we have a number of strong, longstanding partnerships with animal health researchers, and the decision to make the upgrade was an easy one.

When our new release goes live, our customers will have access to new resources that we hope will make their experience with Medrio smoother and more flexible than ever. The Medrio team, meanwhile, will already be turning its attention to the next release.