Leibowitz Law Information

We are a boutique regulatory & transactional law firm dedicated to the life sciences sector, concentrating on clinical trials and digital health, including AI-driven technologies PRACTICE AREAS: Clinical research, regulatory compliance, technology & data, corporate & commercial CLIENTS: Sponsors/manufacturers of FDA-regulated devices, drugs & biologics; digital health companies; technology vendors; CROs; research institutions. Lead outside counsel for clinical trial operations, working with smart, research-driven clients committed to saving lives and enhancing quality of life NICHE: Contracts & counseling for clinical trials & digital health including CTAs, budgets, informed consent, HIPAA, CRO MSAs, core labs, rSDV, EDC, consulting, financial disclosure, DSMB, licensing, SaaS, wearables, website contracts, clickwraps & AI RISK MITIGATION: Highly skilled in indemnification, liability limits, insurance, subject injury, cyber risk & data rights NEGOTIATING EXCELLENCE: In-depth experience negotiating CTAs & related documents with universities, academic medical centers, medical practices and vendors. Skilled negotiators highly attuned to interpersonal dynamics & the unique motivations of each party STUDIES: IDE, IND, pre-market, post-market, on-label, off-label, registry, investigator-initiated, pediatric, HCT/P, HDE, preclinical & more WHY CHOOSE US? • Sophisticated legal, regulatory & business guidance in a small firm setting • Professional, knowledgeable, responsive • Personable, curious, resourceful • Well-informed on evolving legal, regulatory & business landscapes to help clients launch & manage clinical studies, regulated products & vendor services, and navigate the AI “Wild West” • Start-up experience offering strategic insight tailored to emerging businesses • We know the industry dynamics and stakeholder positions • Our tailored approach meets your business needs & risk tolerance with practical strategies for swift contract resolution