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- Joseph Francis on Europe’s Top Regulator Shows His Teeth
- Joseph Francis on Pfizer’s Virtual Trial Recruitment
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Author Archives: Tim Denman
Subjects Want Results
At the end of January, CBI hosted the Patient Centricity in Clinical Trials conference in Philadelphia, PA. At the conference, Joseph Kim, Director of Clinical Operations at Shire, mediated a patient panel focused on their experiences participating in a clinical trial.
Posted in CRO/Sponsor, Sites Tagged CBI, Joseph Kim, Patient Centricity in Clinical Trials, patient panel, Shire, subjects Leave a comment
Virtual Trial Innovation
One of the biggest news items in the industry these past few months has been Pfizer’s REMOTE trial and the effect virtual trials could have on the industry. It seems like technology increases and improves daily, causing all industries to look for ways to best leverage new technology. In the clinical trials space, increased technological [...]
Posted in IT Tagged IIR, Partnerships in Clinical Trials, Pfizer, REMOTE trial, Tim Denman, virtual trial, virtual trial innovation Leave a comment
Operational Excellence?
In preparation of the opening of the education sessions today, I scanned the titles of the six tracks and began to analyze the one title that stuck in my head: Operational Excellence.
The term operational excellence can be interpreted any number of ways. I began thinking about what the phrase meant in the clinical trial space [...]
Should AERS Reports Do More For Patients?
Since its inception in 2007, the Food and Drug Administration Amendments Act (FDAAA) has required the FDA to “conduct regular, bi-weekly screenings of the Adverse Event Reporting System (AERS) database and post a quarterly report….[on] potential signals of a serious risk identified.” Although the act calls for the report of any AEs, it advises prescribers [...]
Quicker Review for Generics and Biosimilars on the Horizon
The FDA’s review process for new drugs is slow. That is not news. But if a new agreement between the agency and the industry is approved by Congress things might get a little quicker.
Posted in CRO/Sponsor, Regulatory Tagged biosimiliars, FDA, generics, Tim Denman, user fees Leave a comment
UN-Administered Database
Collaboration between competitors is a growing trend in the clinical trial community. There have been numerous reports in the past few years of traditional rivals pooling their resources for the mutual benefit of both organizations.
Last week the AP reported a new twist on the concept, as eight drug makers entered into an agreement to share [...]
Posted in CRO/Sponsor Tagged collaboration, database, Tim Denman, tropical disease, UN Leave a comment
Capital Raising for Clinical Trials
Conducting clinical trials is expensive, anyone in the industry can tell you that. Running an effective trial spanning many months, and possibly years, requires a steady flow of cash.
In order to raise the large amounts of money necessary, life science companies often release shares to the public to raise the necessary funds. Traditionally, the direct [...]
Posted in Uncategorized Tagged At-the-Market, ATM, capital, Fund Raising, MLV, Tim Denman Leave a comment
Florida’s New Laws Fight Prescription Drug Abuse
Prescription drug abuse is a growing problem in the United States. The misuse of prescription painkillers in general, and Oxycodone in particular, is a growing business both on the street and in “legal” dispensaries. Nowhere is the problem more prevalent than Florida, highlighted by a report published in the New York Times late last month.
The Wait is Over
The world is increasingly a now society. As members of the digital age we are accustomed to getting all the information we desire immediately. The appetite for the instant has taken control; why wait till tomorrow for information we can secure today. This tell-me-now attitude has effectively killed the suddenly old fashioned surprise. Nowhere is [...]
Posted in Uncategorized Tagged baby, boy or girl, gender, Journal of the American Medical Association, pregnant, Tim Denman Leave a comment
Prescription Drug Spending Up In 2011