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Medrio User Conference: New Products Support Risk Based Monitoring
By Penny Manasco - April 12, 2016
We recently returned from the Medrio User Conference where we presented our experience with using Medrio to collect data required for RBM and remote trial management that was independent of traditional subject clinical data. I am really excited about Medrio’s product roadmap for 2016!
Medrio’s products that excite me are:
mSource—This eSource application works seamlessly with m1 and mCore (EDC) so we have all the features of the EDC (e.g., excellent exports, good query functionality including cross visit edits, randomization, reports). This application can be downloaded and works on both Android and Apple tablets. Pricing is less expensive than with other eSource systems I have seen and you can build the studies yourself—which gives you more control over timelines and costs.
mConsent—Hooray for an eConsent system that integrates directly with the EDC or eSource to transfer informed consent dates. This tool allows for the addition of educational videos or other training materials and can also be used with other EDC systems. The signed informed consent can be emailed or printed for research subjects. The importance of the informed consent process cannot be overstated. It is routinely a top 5 site audit finding by the FDA. Can’t wait to try it in our next trial.
mPRO—to collect data directly from subjects in the clinic. This tool nicely complements the functionality of Medrio’s eDiary.
As you may know, I am a strong proponent of eSource and direct data entry. There are a number of challenges in implementing these tools including managing all the tablets (purchase, set up, and distribution) and tablet performance (tablets freezing, unable to open, etc). We are evaluating this issue carefully to identify the best tablets to use.
The other challenge involves controlling costs when you use multiple technology tools to collect data directly. With applications for eSource, eDiary/ePRO, eConsent, and eTMF/eISF, it is important to have a flexible, cost effective solution to make implementing RBM achievable.
Medrio invited MANA RBM to give a presentation on using the Site Level Forms (including CTMS and RBM functionality) we developed in the Medrio system. MANA RBM developed tools for completing risk assessments, issue management, IP receipt, team training, and eMonitoring reports. These Site Level Forms make reporting easier and allow us to have all the data needed to do remote trial management and RBM—all within one system.
Another exciting part of the meeting involved the unanimous enthusiasm all the users expressed for Medrio’s support team. We have benefited and enjoyed Medrio’s commitment, from the very top, to help all Medrio’s customers become and stay successful.
Stay tuned, we’ll be reviewing more products and services in the coming months.