Crucial Data Solutions, Inc. announced today the latest update to TrialKit, an electronic data capture (EDC) mobile app for clinical trial management. TrialKit empowers research professionals to build, deploy, and manage regulatory compliant (FDA 21 CFR Part 11) research studies entirely on mobile devices. The app’s most recent update added a handful of advanced features to TrialKit’s capabilities: adjudication, risk-based monitoring, handoff mode for ePRO surveys, and device-targeted electronic case report form (eCRF) design.
TrialKit’s newest functionality has streamlined the strategy for adjudicating endpoints, outcomes, and inclusion/exclusion criteria. Research professionals can quickly define the adjudicators’ role and the moderator’s role, as well as questions to present or vote on and when records can be adjudicated.
Also included in TrialKit’s latest update is an enhanced process for risk-based monitoring (RBM). Study managers can quickly define data points that need to be monitored by form, visit, site, and/or subject. If an external modeling tool is being used, it can be connected for immediate updates through the API as the study progresses. A risk-based monitoring approach, coupled with the power of mobile technology, will improve data quality and allow for real-time management, increase the safety of study participants, and dramatically lower the costs traditionally associated with clinical trial monitoring.
Thirdly, with built-in ePRO for study participants to directly fill out surveys, TrialKit now has a handoff function, whereby participants can fill out surveys with a clinician via handoff mode. This alleviates the need to add the participant to the system for them to login on their own. The handoff function is beneficial for older populations or studies where the participants only complete a couple surveys and do not need their own login.
Finally available due to popular demand from app users, TrialKit is capable of device-targeted eCRF design, so forms can be perfectly sized for an array of mobile devices, including iPhones, iPads, and Android phones of varying screen dimensions. This can be accomplished by a few taps within the Form Builder. Research professionals may also pre-define frequently used mobile devices when building a study through a new setting found in Study Configuration.
TrialKit is a native Xcode® app that is available on the App Store® today. TrialKit Patient is a native Android app and is available on Google Play today. The full app is slated to be available on Google Play in late Q2 or early Q3 this year. Users can register for free and immediately begin building their study. Training and support are available at no additional cost to users who would like to utilize any of these new features. For any questions or to learn more about the latest system update, please contact firstname.lastname@example.org.
About Crucial Data Solutions, Inc.
Crucial Data Solutions, Inc. is a forward-thinking company dedicated to developing innovative technologies that reduce the cost of medical research by equipping clinical professionals with the tools they need to advance treatments that enable patients with life-altering conditions to lead better lives. We believe clinical research should be a true partnership between ourselves, research professionals, caregivers, and patients worldwide.
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