Below are archived editions of the monthly newsletter which ended circulation in January 2013. Please click on the edition you wish to view. The page will open as a PDF which you are free to download and save. January 2013 … Continue reading →
I’m trying to understand the diminishing communication that is going on these days. I don’t mean the quantity of communication opportunities, but the reduction in ‘real’ communication. I see e-mails go unanswered and those promised phone calls never occur, all without an explanation. Even the common courtesy of acknowledging a response to an ‘urgent’ request … Continue reading →
As we move into the newly defined world of Risk-Based Quality Management in Clinical Trials (FDA Guidance) a Monitor might think their skills are being tempered and possibly replaced with data reports geared to trigger a site visit because of increased safety events, missed subject visits, low enrollment, etc. Not so – as the number … Continue reading →
Following close on the heels of our newest tool for ePRO, BSI is excited to introduce the new ‘Share Station’ functionality to our rED Cap System. While BSI already has ‘Secure-Link’ that allows transfer of confidential information like protocols, data sets, etc.; this allows rED Cap users access to an internal secure data/document sharing area … Continue reading →
As Steve Jobs famously said at Stanford University in a 2005 commencement address, “You can’t connect the dots looking forward, you can only connect them looking backwards”, there is great value in reflection and dedicated evaluation of the road traveled to the present situation. There is learning to be accomplished by taking the problem, challenge, … Continue reading →
So, you’re the new Monitor, new kid on the block, etc. – doesn’t matter if you’re a newbie to the CRA arena (think gladiator) or you got assigned to a new clinical site; you have incredible power! You can wield the sword of ALCOA and bring sites to their knees; at the very least they … Continue reading →
I recently read an article in the Tampa Bay Business Journal where the CEO of Florida Hospital, Tampa was discussing the importance of customer satisfaction, and how doctors are becoming more ‘emotionally intelligent’. Wikipedia defines Emotional Intelligence (EI) as: “The ability to identify, assess, and control emotions of oneself, of others, and of groups”. I … Continue reading →
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