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Individual research institutions and companies can turn their low-performing teams into high-performing teams by addressing behavioral and personality problems.
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Duke Clinical Research Institute (DCRI) in Durham, NC, has implemented a site start-up team process that quickly shaved 77 days off the amount of time between when the regulatory packet is sent to the trial's activation.
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The clinical research industry's paralyzing delays, millions of dollars wasted on dead ends, and resource inefficiencies are the result of faulty team mechanics, several experts say.
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The U.S. Food and Drug Administration (FDA) wants clinical trial sites to prove their compliance with regulations through better documentation of corrective actions, an expert says.
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Starting new clinical trial (CT) sites requires adequate staffing and equipment, proactive standard operating procedures (SOPs), and budgeting skills.
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Clinical trial (CT) sites should have a basic list of standard operating procedures (SOPs) written and in place before research is initiated, an expert suggests.
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In this study, 2,499 hiv-seronegative men or transgender females who have sex with men (MSM) were randomized to daily TDF/FTC vs. placebo in a multicenter, controlled trial with clinical sites in North America, Latin America, Thailand, and Africa.