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The Secretary’s Advisory Committee on Human Research Protections (SACHRP) is in need of new leadership, as Ernest Prentice is stepping down as chairman.
AstraZeneca is stopping any further work on an investigative drug for the neurological damage caused by strokes, after it failed to show any effect compared with placebo in a Phase III clinical trial.
Sites should look for flexibility when shopping for electronic data capture (EDC) systems and should be aware of the increasing potential for integrating information from electronic medical records (EMRs), according to one prominent vendor.
CDER recommended official action against 6 percent of the 319 clinical investigators it inspected in fiscal 2006, citing them for “serious noncompliance requiring regulatory administrative action by [the] FDA,” according to an agency official.
CDER has recommended official action against 6 percent of the 319 clinical investigators it has inspected in fiscal 2006 as of Sept. 6, citing them for “serious noncompliance requiring regulatory administrative action by [the] FDA,” according to an agency official.
The European Medicines Agency (EMEA) has published a final guidance on the conduct, analysis and interpretation of clinical studies based on small patient pools, such as investigations of treatments for rare diseases and those involving children.
The momentum for electronic data capture (EDC) usage in clinical trials is now beyond the tipping point and should continue to speed up, says Anthony Costello, vice president of Nextrials.
For patients who have recently suffered a heart attack, Pfizer’s Lipitor may reduce the risk of a recurrence by 46 percent compared with Zocor, according to trial results released Sept. 6 by Pfizer.
Seattle-based biotech company Dendreon partnered with Oracle to help it manage the manufacture and distribution of patient-specific cancer treatments in its clinical trials, document regulatory compliance and ensure the security of patient edata, a company executive told PIR last week.
Electronic data capture (EDC) in clinical trials offers a host of benefits for sponsors if done properly, an expert said at a recent FDAnews audioconference.