Global Data Standards and the History of the Smoot

Posted by Chad Birt on Oct 14, 2020 6:00:00 AM

Many industries seek to standardize the data they collect, analyze, and make decisions upon. The pharmaceutical, biotechnology, and medical device industries are no different.

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Topics: Data Management, biometrics, clinical trials, data governance, data operations, Smoot, global library

Don't Settle for Poor Data Management Quality

Posted by Ajay Sadhwani on Oct 8, 2020 6:08:34 AM

Is your current data management provider struggling? Perhaps they are under resourced, have antiquated SOPs, use cumbersome systems, or are simply not a good fit for your team and culture. All these items contribute to poor quality either overtly or more subtly by revealing themselves at, unfortunately, the wrong time.

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Topics: Data Management, Quality Assurance, biometrics, clinical trials, rescue studies

Improving Edit Check Programming: a New Metric

Posted by Ann Conner on Jul 9, 2020 5:27:39 PM

Edit check programming and testing is time consuming and labor intensive. As such, it is efficient to minimize the time spent on programming by getting it right the first time. Historically, data management have measured edit check success as the percentage of edit checks that pass User Acceptance Testing (UAT). However, that may not be the best measure. What if an alternative metric leveraging Lean Six Sigma Methodology was used? The Rolled Throughput Yield (RTY) is a metric often employed in manufacturing operations to detect the probability that a process with more than one step will produce a defect free unit. If we track this metric for the edit check process, we can better gauge the probability of success of the edit check program.

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Topics: clinical trial consulting, Data Management, Database Development, Clinical Research, Biotech

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