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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ExL Pharma’s Clinical Research Operations and Worldwide Networking Summit (CROWN) for 2012 took place in Phildelphia, PA in mid-March. The CROWN event is a combination of five conferences, all co-located in one networking hall, with individual session rooms for each. goBalto sponsored one of the five conferences which was focused on clinical site feasibility, selection, and [...]
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By: Sherry Reuter A frank discussion about studies An interesting discussion has taken place over the last month on LinkedIn in the The Association of Clinical Research Professionals group (view discussion here). I thought it would be of interest to many study sites (as well as sponsors and CROs) so have posted some of the 65 [...]
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Status quo and how things are changing Performing 100% Source Document Verification (SDV) has been the gold standard for years in clinical research. CRAs spent much of their careers checking every datapoint on CRFs against Source Data. But change is here. The amount of SDV checked has decreased from 85% in Q2 2007 to just [...]
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By guest blogger: Michelle LaPage, Research Across America What is a Site Community Outreach Plan? Outreach plan is “outside the box” and is a creative, custom-tailored plan to help increase enrollment for studies, increase the general database, and maximize exposure in the community. This is done by attending events and through the use of research [...]
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I believe that game-changing gains in clinical trial efficiency will be realized only through transparency – specifically the ability of any party involved in a trial to objectively understand trial progress (as allowed by trial design), their own performance (and that of their peers), and collaborate to complete their responsibilities. In a recent PLoS article, I [...]
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By: Sherry Reuter A January. 5, 2012 report from CenterWatch cautions that over the last 5 years, the number of study sites has decreased, with the loss of veteran PIs most sharply in decline. Specifically: The proportion of most active PIs (those who conduct at least 2 clinical trials / year) has decreased from 29% [...]
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First off. Happy New Year! Second, I wanted to share some news for all you folks who follow goBalto’s comings and goings. We’ve successfully completed our FDA 21 CFR Part 11 compliance audit for Tracker! Why is this important? Clinical trial sponsors and sites that run clinical trials must adhere to strict FDA rules and [...]
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goBalto takes London Last week, I had the pleasure of speaking at one of Informa’s latest conferences in London, England: Site Feasibility and Study Start Up. For me, the first milestone was when I boarded my first flight to Heathrow. Even with 80+ mph winds at our rear and a 3 hour shorter flight than [...]
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