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Classic Blog

How to Successfully Manage EDC Clinical Trials: Part 1

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  • 06 Oct
Does the following scenario sound familiar? You have been tasked with starting up a Phase III, 300-patient, 70-site oncology EDC clinical trial with ePRO components. New vendors are being used for both ePRO and EDC. The study is international in scope and will require diary translation. There are a few sites where telecommunications are questionable, so alternative data collection needs may be required. The study is 24 months in duration, excluding follow-up (which can last up to 5 years).
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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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institute of medicine (iom)

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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Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials.
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Almost here! #PCTrials Pre-arrange a meeting w @bioclinica Drop by & s/w David Kiger & Mike Lange. Mike will give a…
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Almost here! #PCTrials Pre-arrange a meeting w @bioclinica Drop by & s/w David Kiger & Mike Lange. Mike will giv…
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RT @bioclinica: Keeping to timelines in #clinicaltrials is key but can be hard to achieve. Join Bioclinica's Justin Hunt a webinar Nov. 2…
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RT @Xtalks: Removing Risk from #ClinicalTrial Management System (CTMS) Implementations @bioclinica
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Our Research Dev. Director Marieke Cajal in a poster presentation at #CNS Summit showed, "How to Scale up Recruitme…
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Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices