Clinical Trials Administrator Archives – March 1, 2011
March 1, 2011
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Key clinical research industry problems stem from dysfunctional, indecisive teams
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. -
Experts' strategies for CR team performance improvement
Individual research institutions and companies can turn their low-performing teams into high-performing teams by addressing behavioral and personality problems. -
Major research organization fine-tunes the site start-up process
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. -
FDA discourages use of memos, looks for more CAPA responses
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. -
CT organizations could learn a lot from practices of brand-new sites
Starting new clinical trial (CT) sites requires adequate staffing and equipment, proactive standard operating procedures (SOPs), and budgeting skills. -
Expert provides list of basic SOPs for CT sites
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.