Protracted clinical trial agreement (CTA) negotiations often delay the start of a study. Understanding each party’s motivation and expectations facilitates quicker issue resolution, thereby expediting the CTA to signature. This webinar discusses CTAs from the perspective of the study sponsor, providing tips along the way for streamlined negotiations. It addresses access and ownership of study data and specimens, the impact of digital health technologies and decentralized clinical trials, cybersecurity concerns, subject injury and indemnification provisions, and insurance obligations. The webinar also provides sites and investigators with an understanding of sponsor concerns with CTAs. It concludes by offering a set of effective strategies for the sponsor and research site to follow.
Clinical Budget Specialists, Contract Research Organizations (CROs), General Counsel, Investigators, Research Administrators, Sponsors
Meet the Presenter
Katherine Leibowitz, JD – Leibowitz Law
Katherine has provided legal services relating to clinical trials for almost 25 years. Clients of her boutique regulatory and technology transactional law firm include sponsors, institutions, technology providers, and CROs. Leibowitz Law provides clinical research, regulatory compliance, technology and data, and corporate and commercial services to the life sciences community.