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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Amanda Coulter Cautions Against Site Indemnification of Sponsors in WGC CenterWatch

With clinical trials for non-COVID-19 drugs and devices picking up, WGC CenterWatch turned to Amanda Coulter for insight into terms community hospitals and physician groups should avoid when negotiating agreements to be sites for clinical trials. Indemnification is a particularly contentious issue, and Amanda counsels her clients to reject sponsors’ requirements for counter-indemnification. Although some sites agreed to such unfavorable obligations in clinical trials agreements during the height of the pandemic, Amanda advises sites to be vigilant against continued use of these unfavorable terms, warning against “spring fever plus COVID fatigue.” In addition to developing research compliance policies and processes, template forms, and template agreements, Amanda reviews and negotiates clinical trial agreements, confidentiality agreements, data use agreements, business associate agreements, and federal grants and subcontracts. Read the full...

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