Beginning at the earliest stages of development, innovative pharmaceuticals, biologics, and medical devices are subject to a web of different regulatory requirements. Our Industry Research and Clinical Trials team regularly engages in the intricate process of helping clients shepherd new products from early-stage development, through clinical development, and on to commercial viability. Our clients represent all sectors of the life sciences research industry, from pharmaceutical, biotech, medical device, and other technology companies to a broad range of contract research organizations and other research services providers.
Where Innovation Meets Industry
Much of our work revolves around relationships between industry sponsors and the many partners on which they rely to operationalize their clinical development programs, where nuanced interpretation of regulatory issues is a business necessity. Our clients trust us to arrange their transactions, negotiate their services agreements and other contracts, and facilitate the efficient implementation of their protocols. We are known for our ability to manage the relationships between and among research-industry players, advising them on critical business issues and resolving areas of potential conflict based on industry knowledge acquired through our decades of work in the clinical research industry.
Focus on Research
Our lawyers think about research support full-time. Most of us have worked on the ground in the clinical research space—as in-house counsel at life sciences companies, for research services providers, and serving on institutional review boards—so we understand the operational implications of our advice. We know best practices because we’ve lived them, and our clients rely on that experience to put in place policies and procedures that keep their research compliance house in order, while allowing them to remain bold in their pursuit of important breakthroughs.
- Supported the vendor and research institution contracting needs of a pharmaceutical manufacturer client that initiated a global Phase III clinical trial of more than 50 sites in 12 countries in coordination with the contract research organization and an international network of local counsel.
- Built research compliance programs and conducted gap assessments of existing compliance programs, providing day-to-day advice and counseling on research compliance matters, and supplying guidance on research billing compliance and financial conflict-of-interest matters.
- Represented numerous pharmaceutical and medical device companies in the drafting and negotiation of clinical trial agreements and investigator-initiated study agreements for trials conducted in the United States and abroad. We also interfaced with research organizations, government entities, clinical research organizations, and third-party suppliers on behalf of those pharmaceutical and medical device companies on a broad range of issues throughout the life cycle of their clinical trials.
- Counseled sponsors on clinical trial issues involving novel technologies involving wearable devices and decentralized clinical trials.
- Served as transactional and regulatory counsel to multiple clinical research site companies in connection with a strategic partnership with, and growth investment by, strategic and private equity firms.
- Created clinical trial research corporate compliance programs for various manufacturers, clinical research organizations, and site management organizations, including compliance with Good Clinical Practices, human subject protection compliance procedures, and procedures regarding investigator-initiated research. The programs also addressed relationships with research sites, researchers, vendors, professional organizations, independent foundations, and other participants in the clinical research process.
- Advised a U.S.-based digital health startup company about regulatory, privacy, data protection, contracting, and fraud and abuse laws in preparation for the launch of its digital health platform. Epstein Becker Green assisted the company in establishing and implementing a research pilot, developing a compliant platform, contracting with providers, implementing a patient engagement strategy, and building trust among other stakeholders.