Simplifying Global Compliance
Items Tagged with 'Study management'
Sponsors seeking to conduct emergency research under the FDA regulation that allows a waiver of informed consent, or a parallel waiver to the Common Rule issued by the HHS secretary, should address a host of difficult ethical issues and ambiguities while developing the trial protocol, according to an expert. Read More
Clinical sites can negotiate better payment terms from sponsors and contract research organizations (CROs), improving their ability to conduct clinical trials without worrying about “when the check is coming,” Michael Jay, director of contracts and budgets at RxTrials, said. Read More
Industry involvement in breast cancer trials may affect study design, focus and results, according to an article published in the online version of the journal Cancer. Read More
Listing clinical trials with a public registry can increase public confidence in the pharmaceutical industry and help patient recruitment efforts, according to an expert speaking at a recent industry conference. Read More
Efficient site selection by clinical trial sponsors can help avoid costly delays in patient recruitment, but many drug and device companies are failing to take the necessary steps. Read More
An FDA advisory committee is recommending that the agency fundamentally change standards for testing new contraceptives to focus on comparative drug studies. Read More
Optimata, an Israeli company, has signed an expanded collaboration agreement with Eli Lilly under which Optimata will use computer simulations to help the pharma giant narrow down the possible conditions under which investigational new drugs are to be tested, saving effort at both the preclinical and clinical testing stages. Financial terms were not disclosed. Read More
All "unanticipated problems" affecting participants in clinical trials sponsored or supported by HHS must be reported under a new guidance from OHRP. Read More
Clinical research information should be included in the Nationwide Health Information Network (NHIN) to enable faster discovery and assessment of cures and treatments, according to a recent report from the nonprofit FasterCures. Read More
Electronic interactive voice response (IVR) and interactive web response (IWR) systems are recommended for drug accountability during a clinical trial, according to two experts speaking at a recent FDAnews audioconference. Read More
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