We are a boutique regulatory & transactional law firm supporting the life sciences community. We dive deep into the clinical trials enterprise and tech commercialization.PRACTICE AREAS: clinical research, regulatory compliance, technology & data, corporate & commercial.CLIENTS: sponsors/manufacturers of FDA-regulated investigational devices, drugs and biologics; technology & services providers; CROs; research institutions & collaboratives. Lead outside counsel for clinical trials operations. Our clients are smart and research-driven. We support their work to save lives and improve quality of life.NICHE: contracts & counseling for clinical trial enterprise: clinical trial agreements, budgets, informed consent, HIPAA, CRO MSAs, core lab, rSDV, EDC, consulting, financial disclosure, DSMB, licensing, web terms of use. RISK MITIGATION: indemnification, limitation of liability, insurance, subject injury, cyber risk.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, IND, pre-market, post-market, on-label, off-label, registry, investigator initiated, pediatric, HCT/P, HDE, preclinical and more.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 studies, products and service provider transactions. • We know the industry and understand the various stakeholder positions. • We get to know your business needs and risk tolerance so that we can deliver practical strategies for quick contract resolution.