Automated Breast Ultrasound Trial to Use Electronic Data Capture

selected Medidata Rave as its standard for electronic data capture (EDC) to perform the U-System, Inc.'s (San Jose, CA, USA) Somo-Insight ABUS clinical study. Medidata's implementation team and eLearning capabilities were key to U-Systems' ability to start a six-site, 20,000-patient study using Medidata Rave in just six weeks.

A privately-funded start-up with a 40-person staff, U-Systems looked to replace its paper-based data collection with an affordable EDC system that would increase efficiencies across its clinical trial process, improve data quality and maintain a sound audit trail for submission of study data for post-market approval. "After evaluating several EDC solutions, we found that Medidata was the only vendor that could meet our specific requirements," said Kathy Quiroz, director of Clinical Programs at U-Systems. "With Medidata, we are not only getting a state-of-the-art EDC tool with Medidata Rave and the service and support our team needs, but we are also able to eliminate unnecessary costs and manage the project on a lean budget."

With the help of Medidata's Implementation Services staff, U-Systems was able to launch its first-ever EDC trial in just six weeks. Medidata Rave's built-in eLearning capabilities were critical for U-Systems to quickly train site staff to become proficient in Rave, saving both time and cost in study start-up. Medidata's eLearning tool also enabled U-Systems to easily certify that all study coordinators completed training before entering study data, as access to the study is blocked until successful completion of the training--a key component for audit trail documentation. With the potential for this initial study to grow to nine sites, U-Systems will continue to rely on Medidata Rave's ability to quickly train site personnel in order to ensure timely and accurate data entry.

"Not only did Rave's eLearning capabilities provide an easily managed audit trail, but its flexibility allowed principal investigators and other site staff to complete the training at their own pace, which they readily embraced," said Ms. Quiroz. "We are currently working with sites that range from community hospitals to standalone breast center clinics to tertiary care academic centers. From interns to experienced study coordinators, Rave lends itself well to a broad spectrum of users."

"Our work with U-Systems is another example of our ability to respond to the needs of biopharmaceutical and medical device companies at any stage of their life cycle - from global enterprises to mid-sized players to start-ups, our technology and our team strive to adapt and deliver results for sponsors, trials and budgets of any size," said Tarek Sherif, CEO of Medidata Solutions.

U-Systems is the leader in developing and marketing dedicated breast ultrasound systems. The U-Systems automated breast ultrasound system (ABUS) is currently cleared under 510(k). The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear-array transducer. The device is not intended to be used as a replacement for screening mammography.

Medidata products and services allow customers to achieve clinical results more efficiently and effectively by streamlining the design, planning and management of key aspects of the clinical development process, pharmaceutical companies.

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