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The Latest Developments in Osteoarthritis Imaging

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  • 20 Sep
I will be at the 2010 World Congress on Osteoarthritis in Brussels later this week. This conference, organized by the Osteoarthritis Research Society International (OARSI), runs from September 23 to September 29 and is a great opportunity to identify some of the new osteoarthritis imaging work that is going on in the field. Osteoarthritis (OA) is a common degenerative disease of the joints that is characterized by cartilage breakdown. It affects about 10% of adults in Western countries. Interestingly last year a work force put together by the FDA to further characterize OA defined it as a disease of the whole joint and not just focused on the cartilage.
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510(k) Approval Process & the Impact of Changes for Medical Devices

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  • 13 Sep

There has been a lot of discussion in the news lately about the premarket clearance process for medical devices under section 510(k) of the Federal Food and Drug Cosmetic Act. This is the approval route by which the majority of medical devices get to market by showing they are comparable to an existing marketed or approved product.

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Clinical Data Collection in Oncology Studies - Most Common Challenges

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  • 08 Sep
Creating a clinical data collection strategy for oncology studies within tight timelines can be extremely challenging. Clinical data managers often face particular issues with interpreting the complexities of the study and implementing the data flow as represented in the protocol.
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Modeling IVR Studies Ship Times

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  • 18 Aug
We often run into cases where an IVR (interactive voice response) system may not generate shipment orders for study kits every day. For example, commonly it seems they may only ship Monday through Thursday. In many cases this could be due to cold chain supplies having to be received immediately and being unable to guarantee that someone will be there to receive the shipment on a weekend. Others, however, may be for unrelated policy reasons. Standard modeling practice says to add a day to the shipping lead-time for every day that is not available for shipping (3 days in the case of the above example). Related to this concept, there is often some confusion for new users about whether the shipping lead-time for the IVR study refers to calendar days or business days.
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