Katherine Leibowitz is a lawyer who has been supporting the clinical trials enterprise for almost 25 years. She co-founded Leibowitz Law eleven years ago, after 17 years at a top ten global law firm. Her boutique regulatory and technology transactional law firm serves sponsors/manufacturers, research institutions, technology service providers and CROs. The firm is laser-focused on clinical trials and technology commercialization. Katherine handles the clinical trial operations contracting process from start to finish, including the CTA, budget, HIPAA authorization, ICF, EDC vendor agreements, CRO MSAs, DMCs and more. In today’s high-tech world of electronic databases, decentralized operations, heightened attention to data rights, cyber risk, AI, secondary research and biobanking, she enjoys bringing templates and contract negotiations up to date to effectively deal with the evolving landscape and get the deal done. Katherine is a frequent speaker and author, and enjoys combining the multiple regulatory, legal and industry norms to provide integrated guidance for the life sciences community.