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- Joseph Francis on Europe’s Top Regulator Shows His Teeth
- Joseph Francis on Pfizer’s Virtual Trial Recruitment
- Nimer Yusef on Can “Clinical Data Integration on the Cloud” be a Reality?
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Author Archives: Kayda Norman
Pfizer’s Virtual Trial Recruitment
Last week, I recently wrote an article about the legal risks involved with virtual clinical trials (see our April issue for details), which made me curious to see how the first virtual trial from Pfizer was coming along.
As most already know, in June Pfizer launched the REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) [...]
Posted in CRO/Sponsor, Sites, Trial Design Tagged Kayda Norman, patient, Pfizer, REMOTE, subject recruitment, virtual trials 3 Comments
Using Crowdsourcing to Improve Decision Making and Innovation
To be honest, when I first entered the session, “Crowdsourcing Clinical Development and Medical Innovation,” with speaker James Surowiecki, columnist for The New Yorker and author of The Wisdom of Crowds, I had no idea what to expect. I had never even heard of crowdsourcing before, but took the fact that the room was slowly [...]
New Anti-Falsification Regulations for EU QPs
Although the falsification of data has been a concern in both the United States and Europe for several years, recently the issue has been brought to light more prevalently. The FDA proposed regulation for reporting the falsification of data in clinical trials in 2010, and the EU released new legislation regarding anti-falsification at the end [...]
Posted in Regulatory Tagged anti-falsification, EU, FDA, GxP Perspectives, Kayda Norman, QPs, qualified person, regulation, Wolfgang Schmitt Leave a comment
Are Black Box Warnings Enough? Should FDA Do More?
According to a recent report from Medco Health Solutions (download here http://medco.mediaroom.com/), one in five insured Americans has taken at least one psychotropic medication in the past year. Overall, Americans have increased their intake of psychiatric medications by 22 percent (from 2001 to 2010), with women 45 and older showing the highest use of these [...]
Posted in Regulatory Tagged antipsychotics, Black Box Warnings, David Muzina, FDA, Kayda Norman, Medco, psychotropic medications, Regulatory Leave a comment
£180 Million Program to Support UK Life Science Businesses
The Prime Minister recently announced some welcome news for the UK’s life science businesses: The Technology Strategy Board, a government body intended to help ensure the United Kingdom is a global leader in innovation, and the Medical Research Council, a government agency that encourages and supports research to improve human health, are managing a three-year [...]
Posted in Uncategorized Tagged Biomedical Catalyst Fund, Medical Research Council, NHS, Technology Strategy Board, UK Leave a comment
Merck Releases First-Ever Approved Diabetes-Cholesterol Pill
It has been proven several times that people are not taking their medications correctly. Whether they are too busy running around after their children, burdened with work at their job, or simply preoccupied, patients often neglect to take their medicine at the right time consistently, or worse, may forget to take it at all (I [...]
Azithromycin Reduces Exacerbations, At A Cost
Imagine that you lived in fear everyday that you would suddenly lose the ability to breathe. It could happen at any moment, and become so severe that you would need to be placed on ventilators. Oh, and your condition also happened to be the third leading cause of death in the United States. No big [...]
Posted in Uncategorized Tagged chronic obstructive pulmonary disease, exacerbations, lung disease, OCPD, twincities Leave a comment
HIV Treatment Highlights
Centers for Disease Control and Prevention estimates that more than one million people are HIV positive in the United Staes. Thankfully, there has recently been several advances in clinical trials and drugs for subjects with HIV.
Posted in Uncategorized Tagged Aeras, Complera, FDA, Gilead Science, HIV, Ocford-Emergent-Tuberculosis Consortium, TB, Tuberculosis Leave a comment
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