Our boutique technology and regulatory transactional law firm serves the life sciences sector: NICHE: contracts & counseling for clinical trial operations: draft and negotiate clinical trial agreements, budgets, rSDV, 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; vendors; institutions & collaboratives. Lead outside counsel for clinical trials operations. Our clients are smart and research-driven. We support the development and testing of innovative products to save lives and improve quality of life. LAW FIELDS: indemnification & risk management; FDA regulatory; fraud and abuse; privacy; financial transparency & conflict of interest; IP; cyber risk; technology law; licensing; data rights; general contract law (draft, negotiate, amend, terminate, interpret). 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. 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.