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While the U.S. heads the global pack in nanotechnology research, not enough money is being spent on studying the environmental, health and safety (EHS) risks nanotechnology presents, according to a report by the National Research Council assessing the National Nanotechnology Initiative (NNI)for Congress.
Biopharmaceutical and ehealth initiative standards must converge to help electronic health records (EHRs) become a regular source for clinical research, said a discussion paper from the eClinical Forum and PhRMA EDC/eSource Task Group.
Integrating physical access systems with related technologies such as RFID and enterprise single sign-on tools can help companies strengthen their edata security programs, said a new white paper from Imprivata.
Merging electronic health records (EHRs) and electronic data capture (EDC) is about more than finding the right technology, said experts gathered last week at a conference in Washington, D.C.
Researchers at Siemens Medical Solutions (SMS) and the Technical University of Munich (TUM) unveiled last week a method of electronically transferring clinical data gathered at the source (or point of care) for use in clinical trials — but the method is not yet compliant with 21 CFR Part 11.
The biggest hurdle in switching from paper case report forms to electronic data capture (EDC) in clinical trials “is making sure you’ve clearly defined and documented your processes,” said Linda Staley, vice president of information technology at Dendreon, a Seattle-based firm that develops treatments that harness the immune system to fight cancer.
Two leading electronic data capture (EDC) providers have settled patent infringement lawsuits with a little-known Maryland firm, in one case for a multimillion-dollar amount.
In an effort to boost the development of personalized medicine, the FDA will implement a pilot project, beginning next year, to detail the factors the agency will use in approving new biomarkers, an FDA official says.
One of the largest drug-eluting stent makers, Boston Scientific, is looking at the way it designs these devices after new clinical trial analyses linked them to an increased risk of blood clots.
The FDA announced in late August it has entered into a three-year agreement with two national institutions to facilitate the development and regulation of nanotechnologies for research and cancer treatments, but one critic asserts the agency also needs to take similar actions for over-the-counter (OTC) products.