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Research institutions need a best practice plan for preventing and handling regulatory issues whether they have 50 or 500 new studies a year.
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Clinical study sites are carrying a greater part of the compliance burden these days as sponsors increasingly are shifting responsibilities their way such as the task of making source documents, an expert says.
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Clinical trial (CT) sites and principal investigators can improve their budget cash flow by spending more upfront time on the budgeting process before signing contracts with sponsors.
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Medical and research institutions have a great deal more to fear these days from aninadvertent release of protected health information (PHI).
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Sponsor-initiated clinical trial agreements are well-worn pathways, so it makes sense that the latest trend of recent years is for research sponsors and research institutions to use master agreements.
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Research institutions often lack policies and programs to deal with research participants' injuries. This neglected area of concern could prove problematic when injuries occur and result in litigation.
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Obesity currently is the nation's greatest public health challenge. Serious chronic disorders are rising rapidly among children, teens, and young adults.