Smith Moore Leatherwood's highly experienced health care attorneys provide a wide range of services to health care clients engaging in the medical research and discovery process. Our particular focus is on academic medical centers and other institutions where federally funded and industry sponsored research is conducted, and on hospitals, physicians, physician groups, and health systems that participate in all types of clinical research. We help our clients maintain regulatory compliance and assure that their interests are protected so their time and energy can be concentrated on the advancement of medical knowledge. We provide counsel on the full range of issues arising from research activities. For example:
We negotiate and draft:
- Sponsored Research Agreements
- Research Consortia Agreements
- Material Transfer Agreements
- Confidential Disclosure Agreements
- Clinical Trial Agreements and Budgets
- Strategic Alliance and Joint Venture Agreements
We advise and counsel clients about:
- Medicare Reimbursement for Clinical Trials
- Fraud and Abuse Issues in Research Programs
- Research Issues and Tax-exempt Status
- Protection of Human and Animal Subjects in Research
- HIPAA Privacy and Research
- FDA Regulation and Compliance
And we assist with obtaining intellectual property protection, including:
- Preparing and Prosecuting Patent and Trademark Applications
- Licensing of Patents, Trademarks and Technology
- Performing Patent, Trademark and Copyright Infringement Analyses
- Conducting Intellectual Property Audits and Due Diligence Reviews
Our experience with the legal aspects of medical research is far reaching, and our commitment to this area of law practice is deep. Our involvement with medical research activities is some of the most rewarding work we do; it allows us to have a small part in the process that leads to real health care benefits.