Clinical Research

Our work includes:

• Clinical research and clinical trials compliance, including conducting compliance evaluations of clinical research programs, providing support in addressing federal and state audits and investigations related to scientific research activities.
• Providing regulatory advice for all aspects of clinical research, including clinical trial strategy support, management systems, diversity in clincial research, guidance on pharmaceutical device and product development, and workforce training.
• Negotiation of research related arrangements, including engaging in the negotiation and preparation of grants and contracts with both governmental and industrysponsors, IRBs, and other entities involved in clinical research such as clincial research organizations and other vendors.
• Developing clinical research policies, such as creating and implementing policies and procedures specifically tailored to clinical research in the life sciences sector within the United States and outside the United States.
• Drafting and negotiating IRB agreements, including preparing and negotiating agreements with IRBs to ensure ethical and regulatory compliance in clinical research.
• FDA regulation of clinical research products, by understanding and adhering to FDA regulations concerning the development, testing, and approval of drugs, medical devices, and biologics.
• Managing conflicts of interest in clinical research, by identifying and managing potential issues that may arise in clinical research to maintain integrity and transparency.
• Providing guidance on research terms, conditions, and cost principles specific to clinical research projects.
• Ownership and access to clinical research data, including addressing issues related to the ownership, access, and sharing requirements of research and health data, such as the creation of a data repository for future research.