At Nelson Hardiman, we see clinical research as the place where innovation can thrive, centered on initiatives to move medicine forward. We apply our healthcare industry experience to navigating the legal considerations and regulatory compliance issues required to set up, monitor and complete a clinical research trial.
Our team of healthcare-focused attorneys have advised extensively on the federal anti- kickback statute and IRS requirements, and on the implications for clinical trials. We counsel clinical trials companies on the development of clinical studies that comply with HIPAA and state health information privacy laws, negotiate contracts, and set up monitoring and auditing standards that comply with federal, state and local regulations. Nelson Hardiman can guide your clinical research trial every step of the way from inception to completion.
Related PracticesGovernment InvestigationsLitigationRegulatory ComplianceTransactions
Our Work Includes:
- Program Development Counseled clinical trials companies on HIPAA and state health information privacy laws and development of privacy compliance programs.
- Regulatory Leadership We play a leadership role in regulatory compliance, guiding clients on risk avoidance and the essential challenges implicit in the development of new health technology, medical device, pharmaceutical and digital health-related products and services.
- Telehealth Advised telehealth provider utilizing proprietary technology and clinical protocols to deliver standardized, ultra low-cost care hyper-efficiently, leveraging clinical intelligence embedded in the technology.
- Telemedicine and Healthcare Technology Advise telemedicine and other health care technology clients on clinical trial development, providing expertise on telemedicine, fee splitting, anti-kickback, and other healthcare regulatory issues.