TrialKit, a fully-featured eClinical platform, utilizes the latest in mobile technology to provide researchers with the most efficient method for clinical trial data collection. It is a regulatory compliant, ready-to-use native mobile app offering numerous features, including medical coding and ePRO.

Crucial Data Solutions (CDS) is excited to announce a real solution to make clinical trial sites and study participants truly unified. TrialKit, a native mobile app, empowers investigators and clinicians to build, deploy, and manage regulatory compliant (FDA 21 CFR Part 11) research studies entirely on mobile devices. With TrialKit, clinical researchers can utilize Core Motion technologies and Apple’s HealthKit to collect a greater quantity of objective, accurate data in the clinical trial process.

Paul Grady, President of CDS, had this to say, “TrialKit now allows research professionals to accurately measure heart rate, step motion and range of motion. The Apple Watch has completely changed how we think about collecting data from study participants.” Researchers can instantly design a study to collect these and other valuable data points utilizing Core Motion technologies with simple drag-and-drop gestures on a mobile device.

Clinical trials are no longer confined to desktop computers and paper forms. TrialKit leverages the latest in mobile technology with just a few taps on a mobile device. It is capable of everything from integrating activity tests via HealthKit, to using geolocation (GPS) for stamping coordinates on electronic CRFs, collecting image and video files, and utilizing the device’s microphone for dictating data into all fields.

~ One App, No Coding

From a single mobile app, research professionals can build and manage any number of research studies. Other mobile apps are only capable of managing one study within a single instance, making TrialKit an unparalleled system.

TrialKit is a regulatory compliant, out-of-the-box native mobile app, so clinical researchers do not require any programming knowledge or developers to code and configure the app on which they’ll be collecting data. The time and resources saved due to TrialKit’s ready-to-use design result in substantial cost savings, making it appealing to all research teams.

~ Exclusive Certified Native Mobile App for Medical Coding

TrialKit is the only mobile app on the market with medical coding capabilities, providing research professionals with the unprecedented ability to code and approve on-the-go with direct access to MedDRA and WHODrug B3/C3 dictionaries. In addition, csCoder, CDS’ coding solution, is built into TrialKit and designed to ensure data submissions adhere to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) standards.

~ Optimal Participant Engagement

Electronic participant reported outcomes, or ePRO, allows study participants to quickly and easily complete forms and surveys on their smartphone or tablet, even including photo or video files as needed. Researchers can automate the entire notification process to enforce survey completion with email or in-app push notifications. ePRO is integrated into TrialKit, available on the App Store® today; it will be available on Google Play as TrialKit – Patient for participants to download and use in August.

The next generation of clinical trials can now be executed anytime and anywhere with innovative mobile technology. TrialKit replaces paper source documents with electronic CRFs – resulting in cleaner data than ever before. The removal of paper source documents substantially lowers data entry mistakes as well as trial overhead and study duration.

TrialKit is available for use on Apple® devices now, and will be coming to Android™ this September. Currently, TrialKit is available at no cost for 30 days. Beyond the 30 day trial, the app is $499/month with no limit on sites, users, or studies. For individual researchers, TrialKit is just $99/month, and is always available at no cost to students in support of new researchers worldwide.

About CDS

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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