A new drug or medical device must go through clinical trials before it can be publicly marketing. Federal guidelines and regulations are intended to protect human research subjects who participate in these clinical trials. Our legal team provides counsel to manufacturers and entrepreneurs in the start-up phase of a new drug or medical device to ensure compliance with informed consent and other clinical research legal rules.
Our legal advice can include:
- Advising on Data Privacy and Security Issues
- Coordinating Development of Clinical Trial Protocols
- Drafting and Negotiating: Agreements with Clinical Research Organizations (CROs)
- Clinical Trial Agreements
- Confidentiality Agreements
- Joint Venture Agreements
- Material Transfer Agreement
- Research Consortia Agreements
- Sponsored Research Agreements
- Strategic Alliance Agreements
- Preparing Research Informed Consent Documents
- Providing Regulatory FDA Compliance Advice
- Reviewing Fraud and Abuse Issues in Research Programs
For more information about our Clinical Trials legal practice, contact our Legal Team.