By Swadesh Sharma TMF Today The Trial Master File (TMF) is the heart of every clinical trial. The TMF often paper/binder based is a collection of essential regulatory documents which are required to initiate a trial within an investigative site. Being paper/binder based on the site side, requires constant manual update and management. This may [...]
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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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goBalto + Tufts Center for the Study of Drug Development = Ground breaking benchmarking study on study startup. Background It was 12 months ago when goBalto and Tufts first initiated discussions about a potential benchmarking study (when Tracker was nothing more than a dream). Following a recent evaluation of the present-day Tracker it was determined [...]
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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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I have been working on several blogs this week and while many will resonate quite well with most if not all of us in this industry, I had to pull back and really ponder on one topic that has had me thinking a lot lately. The question of why we are in this industry and [...]
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