“My prediction is that clinical trials in 10 years’ time will be very hard for us to recognize,” Leonard Sacks, MD, associate director for clinical methodology in the Office of Medical Policy at the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), told attendees of the agency’s Clinical Investigator Training […]
The quest for greater levels of patient engagement in clinical trials is surfacing as a clearly stated driver behind more and more new research partnerships and services being announced in recent months. Just this week, the contract research/commercial organization Syneos Health revealed a strategic partnership with data analytics company AiCure to “drive faster, smarter trials […]
The Association of Clinical Research Professionals (ACRP) welcomes OhioHealth Research Institute as the latest member of the ‘Workforce Innovation Steering Committee’ (WISC). The WISC is a collaborative partnership of private and public stakeholders working to improve clinical trial quality and respond to changes impacting the workforce by providing oversight for needed standardization activities. The partnership […]
This session will provide an overview on how to appropriately identify, document and address compliance issues noted at sites, from monitoring and Sponsor perspectives. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.
RegisterThis session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions.
RegisterWe invite all CRCs, CRAs, Project Managers, Regulatory Liaisons, and other study personnel to join this webinar for a review of our responsibilities and a discussion of these relationship. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and open forum for discussion provided.
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