A little help goes a long way. Study sites try hard to enroll and retain study subjects. However sometimes sites are so busy working on everything they have to do on their end that they may not always be attuned to some factors that can make a big difference to people on the other end [...]
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What type of site are you? There are many types of study sites and business models they work under. Do you know what they all are, what their differentiating features are, and under what circumstances each type might (or might not) be advantageous to you when selecting sites? Are you an ISN? One type of [...]
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I was talking to a colleague who manages a study site about situations in which sites and sponsors might seem to be far apart and how that affects the clinical research enterprise. Most importantly, what, if anything, can be done in those cases? The situation presents itself… A common example this site manager cited is [...]
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Introduction I read with interest the beginning of this series titled “Sites – It’s Where the Patients Are!” and “The List”. What a great start to a conversation amongst some of the major players in the clinical trials arena. But I believe one of the crucial players was not mentioned – the IRB. I have [...]
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Introduction I have been a PI for 17 years having conducted pharmaceutical and device studies for both established and startup sponsors and CROs. As a practicing obstetrician/gynecologist, participating in clinical trials has given me the opportunity to offer cutting edge treatments to my patients and has kept me current with trends in my specialty. Most [...]
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Forward by: Dan Manak, Director of Business Development, goBalto, Inc. Sites – It’s Where the Patients Are! Ever since I left my first job out of college (late 80’s), working in an environmental organic chem. lab, I think I have been working directly with physicians and their offices. From that lab, I went to carry [...]
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How long has going paperless been a goal in clinical trials? Ever since the first remote data entry systems were utilized some 20 years ago there has been the promise of being able to one day be in a world, (clinical) that stops or barely uses paper. Maybe now that the interfaces that we utilize [...]
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Pharmaceutical translation and localization is not an option, but an ethical and lawful imperative when new drugs are being tested and existing drugs are being marketed globally. A pharmaceutical company’s successful international presence demands an ethical commitment to the ethnic market. A vast number of the clinical trials are currently held abroad where where accurate [...]
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Dan Manak – Director of Business Development at goBalto – attended DIA solo this year. Here’s his summary of what he saw and experienced there as an attendee and speaker. DIA 2011 – Recap from the Front Lines DIA 2011 was my seventh trip to the annual event and this year came with two personal [...]
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This is an ode to all you folks working in a startup. Up: first sip of coffee (or tea) in the morning Down: 50 emails to respond to Up: only 10 emails really urgent and resolved Down: critical feature didn’t make release Up: based on customer feedback, realize “critical” feature not on critical path Down: [...]
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