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Tag Archives: data standards
Download the Slides from the Data Quality and Integrity Webinar
Yesterday’s free webinar, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval,” was a great success! For those who would like them, the slides from the presentation are now available for download here (PDF file). Stayed tuned Ask-Cato.com for … Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged Cato Research, clinical study report, clinical trials, data standards, drug development, marketing application, regulatory affairs, webinar
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Data Quality and Integrity: From Clinical Monitoring to Marketing Approval
At 2:00 PM ET on Thursday 18 November 2010, Cato Research will host a webinar titled, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval.” The webinar will be presented by Nancy Detich, Ph.D., a Senior Clinical Strategy Scientist … Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged Cato Research, clinical study report, clinical trials, data standards, drug development, marketing application, regulatory affairs, webinar
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Improving Assessment Data Consistency in Multi-Center Studies
Ensuring assessments are conducted, analyzed, and reported consistently across sites is a challenge facing managers of multi-center clinical studies. While identification and quantification of between site variation is typically part of the statistical analysis, collecting more consistent data from the … Continue reading
DIA 2010 – Week in Review
The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location. In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas … Continue reading
Posted in Conferences and Meetings, eCTD, FDA
Tagged adverse events, biomarkers, biotech, cell therapy, clinical development, clinical trials, CMC, comparative effectiveness, data standards, DIA, eCTD, FDA, globalization, in vitro diagnostics, personalized medicine, pharmacokinetics, Phase 1, Phase 2, RPS, study tagging files, transparency
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