Life Sciences Practice
The Law Office of Katie W. Cohen has extensive experience advising drug and medical device companies in connection with pre-clinical and clinical research and development, including
- Review, preparation and negotiation of the following agreements:
- Clinical Trial Agreements – Our office has negotiated numerous clinical trial agreements with U.S. and foreign research institutions and universities and can assist in the development of template clinical trial agreements and in negotiating pre-existing templates.
- Confidentiality/Nondisclosure Agreements – Our office has negotiated numerous confidentiality/nondisclosure agreements with institutions and investigators and can assist in the development of template confidentiality/nondisclosure agreements and in negotiating pre-existing templates.
- Services Agreements – Our office has experience reviewing and negotiating services agreements with contract research organizations, laboratories and other pre-clinical and clinical trial service providers.
- Materials Transfer Agreements – Our office has extensive experience negotiating materials transfer agreements with universities, research institutions and companies and can assist in the development of template materials transfer agreements and in negotiating pre-existing templates.
- Data Safety Monitoring Board Agreements
- Research and Development Agreements
- HIPAA Data Use Agreements
- Collaborative Research and Development Agreements with the U.S. Government (CRADAs)
- Consulting Agreements
- Scientific Advisory Board Member Agreements
- Review of Patient Informed Consent Forms and HIPAA Authorizations
- Review of Research Protocols and Investigator Brochures
- Review of Financial Disclosure Forms