Clinical Research & Clinical Trials
Sonnenschein attorneys have extensive experience advising academic medical centers, universities, hospitals, health systems, physician groups, pharmaceutical and device manufacturers and other health care organizations in connection with all aspects of clinical research and related compliance issues. Working closely with research institutions, clinical trial sponsors and institutional review boards (IRBs), our attorneys—two of whom are Certified IRB Professionals—are well positioned to provide assistance with the full range of clinical research issues from projects related to budgeting, clinical trial contracting and institutional review board (IRB) processes, to post-trial award accounting and disclosure issues. Specifically:
- Sonnenschein attorneys work with academic medical centers, hospitals and faculty practice plans to review current processes, provide gap analysis and implement billing policies and procedures that comply with Medicare, Medicaid, and other legal and contractual requirements.
- Health Care Group attorneys have extensive experience advising research industry stakeholders concerning the increasingly complex research funded by the public and private sectors, including the application of civil and criminal fraud and abuse laws to myriad research funding arrangements.
- Sonnenschein attorneys undertake an array of research program compliance audits, including audits relating to human subject protection regulations, management of federal grants and contracts and alleged research misconduct.
- Our attorneys assist clients under investigation and audits by the FDA, NIH, OHRP, DOJ, OIG and other federal agencies relating to research-related issues.
- Sonnenschein attorneys have experience regarding the HIPAA Privacy Rule's impact on research operations.
