Amanda Coulter Demystifies Clinical Trial Agreements

During a recent Arizona Society of Healthcare Attorneys (AzSHA) webinar, Attorney Amanda Coulter shared her clinical trials legal expertise and provided a deep dive into clinical trial agreements (CTAs). This topic is essential to research sponsors, research personnel, and other healthcare stakeholders, helping them navigate complex regulations and legal contracts. Throughout the “Clinical Trials 101: What Health Care Lawyers Need to Know Now” webinar, Amanda spoke on the typical terms and issues encountered in CTAs, additional variations of research-related agreements and strategies for negotiations of research agreements.  Amanda also covered the main laws and regulations governing clinical trials. Amanda Coulter has extensive experience negotiating research agreements and developing research compliance policies and processes, template forms, and template agreements. She assists clients by reviewing and negotiating confidentiality agreements,...

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Kristen Rosati and Amanda Coulter Advise AHLA on COVID-19’s Impact on Clinical Trials

The COVID-19 public health crisis is having a profound impact on all aspects of the health care system. Kristen Rosati and Amanda Coulter teamed up to inform the American Health Law Association (AHLA) about how it will affect clinical trials.AHLA Weekly published their article, “How the COVID-19 Pandemic Immediately Impacts Clinical Trials: Considerations for Sites and Investigators,” which addresses the need for sites and investigators to be simultaneously rigorous and flexible. It also covers determining criteria to determine which trials will continue; vetting, implementing, and documenting changes for continuing trials; and communicating changes with sponsors and participants. Kristen, a nationally recognized and respected leader in health care law, has served in numerous leadership positions within AHLA – including president of the association from 2013-2014. She is considered one of the nation’s leading Big Data...

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