Leibowitz LLC
Law Practice - , Pennsylvania, United States
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Our boutique life sciences law firm:NICHE: contracts & counseling for device/drug/biologics clinical trials contracting process and beyond. Clinical trial agreements, budgets, informed consent, HIPAA authorization & BAA, GDPR, CRO services, core lab, EDC, consulting, financial disclosure, DSMB, licensing, web portal. CLIENTS: manufacturers of FDA-regulated investigational devices, drugs and biologics; CROs. Lead outside counsel to sponsors for all clinical trials contracting matters. Our clients are smart, research-driven creators of medical technologies. We support their development and testing of innovative products to improve patient health and quality of life.LAW FIELDS: indemnification & risk management; FDA regulatory; fraud and abuse; privacy; financial transparency & conflict of interest; intellectual property; technology law; licensing; data rights; general contract law (drafting, negotiation, amendment, termination, interpretation).NEGOTIATING EXCELLENCE: Extensive, in depth experience negotiating CTAs and related documents with public and private universities, academic medical centers, physician practices and multiple vendors in the field. Highly-skilled negotiators, sensitive to interpersonal dynamics and the motivations of each contracting party. STUDIES: IDE, pre-market, post-market, on-label, off-label, retrospective, investigator initiated, preclinical and animal studies.WHY CHOOSE US? • Sophisticated legal, regulatory and business advice in a small firm, personal setting. • Professional, knowledgeable and timely. • Personable, curious and resourceful. • On top of the ever-changing legal, regulatory and business environments to help you effectively launch and manage your clinical study lifecycle transactional needs. • We know the industry and understand the positions of all stakeholders. • We get to know your business needs and risk tolerance so that we can deliver practical strategies for quick contract resolution.
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