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Automated Breast Ultrasound Trial to Use Electronic Data Capture

By MedImaging International staff writers
Posted on 04 May 2009
An electronic data capture (EDC) system has been chosen to perform a clinical study of an automated breast imaging ultrasound system (ABUS) for early detection of breast cancer.

Medidata Solutions (New York, NY, USA), a global provider of hosted clinical development systems, reported that U-Systems, Inc. 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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89 (34.093856811523): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`
90 (79.154968261719): SELECT show_live FROM jos_com_show_setting LIMIT 1
91 (30.040740966797): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (24.795532226562): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (25.98762512207): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (24.795532226562): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (25.033950805664): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (722.88513183594): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
105 (65.088272094727): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
106 (57.93571472168): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294723037 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (41.961669921875): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294723037 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (72.002410888672): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
109 (43.869018554688): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
110 (76.770782470703): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294723037 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (351.90582275391): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294723037 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (554.08477783203): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
113 (364.06517028809): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
114 (73.909759521484): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
115 (43.153762817383): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
116 (55.074691772461): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
117 (36.954879760742): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
118 (61.988830566406): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
119 (36.001205444336): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
120 (47.922134399414): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
121 (38.14697265625): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
122 (236.03439331055): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 18744.945526123): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
124 (505.92422485352): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294723037 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294723037 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (!!!!! 7068.8724517822): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
126 (69.141387939453): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
127 (301.83792114258): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
128 (36.954879760742): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
129 (227.92816162109): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
130 (35.04753112793): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
131 (185.01281738281): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
132 (32.901763916016): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
133 (201.94053649902): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
134 (33.855438232422): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
135 (449.18060302734): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (340.93856811523): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (209.09309387207): SELECT name FROM jos_deeppockets WHERE id=216
138 (48.160552978516): SELECT name FROM jos_deeppockets WHERE id=216
139 (576.97296142578): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))216((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (463.96255493164): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))216((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (97.036361694336): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
142 (53.882598876953): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
143 (!!!!! 7713.794708252): TRUNCATE TABLE jos_trademed_module
144 (122.0703125): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294723037 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (54.121017456055): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294723037 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (939.13078308105): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (53.882598876953): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (68.902969360352): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
149 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
150 (!!!!! 1087.9039764404): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
151 (56.982040405273): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
152 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
153 (38.14697265625): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294723037 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294723037 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (420.09353637695): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=216 or channel_id is null)
155 (37.908554077148): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=216 or channel_id is null)
156 (30.994415283203): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (56.982040405273): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
158 (36.954879760742): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294723037 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294723037 AND published='1' LIMIT 1
159 (66.041946411133): select jos_twitters.link from jos_twitters where cat=10
160 (37.193298339844): select jos_facebook.link from jos_facebook where cat=10
161 (30.040740966797): select jos_google_plus.link from jos_google_plus where cat=10
162 (27.179718017578): select jos_linkedin.link from jos_linkedin where cat=10
163 (216.00723266602): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14202,14203)
164 (935.07766723633): insert into jos_banners_delta values (14202,'2025-06-22 01:11:23','216.73.216.120','view'),(14203,'2025-06-22 01:11:23','216.73.216.120','view')