Items Tagged with 'Study management'


Tackle Ambiguities Upfront in Emergency Research

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.

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Sites Can and Should Negotiate Better Payment Terms

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.

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Computer Modeling of Drug Trials Holds Promise Within Limits

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.

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Sponsor Best Practices

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