Leibowitz Law

We are a specialized law firm focused on regulatory matters and transactions within the life sciences sector. Our expertise extends into the realms of clinical trials and technology commercialization, ensuring thorough support for our clients in these areas. Our services encompass a range of practice areas including clinical research, compliance with regulations, technology & data management, as well as corporate affairs. Our clientele consists of manufacturers and sponsors dealing with FDA-regulated investigational drugs, devices, or biologics; technology providers; contract research organizations (CROs); as well as various academic institutions collaborating on research. We often serve as lead external counsel during their clinical trial operations. With a commitment to enhancing lives through diligent legal support for pioneering research initiatives—our niche lies in offering guidance tailored to the complexities of contracts related to the clinical trial process: drafting agreements such as CTAs (Clinical Trial Agreements), managing budgets effectively while adhering to informed consent protocols—including navigating HIPAA regulations—and working extensively on CRO master service agreements alongside financial disclosures relevant for Data Safety Monitoring Boards (DSMB). Risk mitigation strategies form an essential part of our approach too—addressing indemnification needs while limiting liability exposure across various scenarios including participant injury concerns and cyber risks associated with studies that span from IDEs (Investigational Device Exemptions) through INDs (Investigational New Drugs), pre-market evaluations up until post-market assessments involving both pediatric investigations along with registry-based efforts. Why partner with us? You’ll experience sophisticated yet personalized legal insights delivered promptly by professionals who remain personable and resourceful even amidst shifting regulatory landscapes. We take pride in recognizing diverse stakeholder perspectives so we can align our strategies accordingly—to propel your business objectives forward swiftly without compromising quality or safety throughout your endeavors within this complex industry landscape.