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How To Fix Ineffective Subject Screening At Clinical Sites

Even when sites are able to recruit a large pool of potential subjects, sponsors and contract research organizations (CROs) see far too many subjects who fail to pass the screening visit (screen failures) and subjects who pass the screening visit only to leave the study early (early terminations). Because sites get paid for every subject […]

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Eli Lilly Launched 50+ Apps On Salesforce

As one of Salesforce’s strategic partners, I’m glad to share the success Eli Lilly is having with the Salesforce platform. According to a press release that was issued by Salesforce, the pharmaceutical company has launched 50+ internal and external applications over the last two years. TrialGuide is one example. The website, which is naturally mobile-friendly, […]

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Transfer Subjects From Site To Site With Siebel CTMS IP2016

Study managers, rejoice! In Oracle’s innovation pack 2016 (IP2016) for Siebel Clinical, Oracle introduced a new feature that allows subjects who are enrolled at one site to be transferred to another – without losing any history. Here are some highlights of the subject transfer feature: Ability to transfer subjects from one site to another within […]

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Don’t Let Your Investigators Ruin Your Study By Doing This

I enjoy reading FDA Warning Letters. They’re insightful and often entertaining. Sometimes, though, they’re kind of unbelievable. And, sometimes, they’re downright nauseating. Take, for example, this letter issued on February 19, 2016 to a principal investigator (PI) based in New York. FDA inspectors found him to be in violation of 21 CFR Part 312.62(b), related […]

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