As a research institution, you operate in an industry of ever-changing innovation, and you need solid business advice that keeps pace with your research. Faegre Baker Daniels provides the counsel U.S. and international research institutions need to successfully test new technologies and innovate the health care and life sciences industries.

Our professionals have experience advising large academic institutions and smaller startups on every aspect of drug, diagnostic, device and tissue clinical research, including industry-sponsored and investigator-initiated trials. We guide you through trial development, regulatory strategy, contracting, publication, privacy and security issues, and reimbursement. To ensure your research is operated efficiently, cost effectively and successfully, we integrate corporate, regulatory and intellectual property services.

Research Agreements

We draft and negotiate research organization agreements, consent forms, and clinical trial and investigator disclosure agreements that position you for success. Often, corporate, academic and government institutions join forces to stimulate new research and business activity through public-private partnerships. We have been lead counsel in the establishment of public-private partnerships to develop proteomics technologies and biomarker discovery services, and we can guide you through this process.

Regulatory Compliance

As you develop unique and innovative technologies, you must deal with an increasingly complex maze of regulations governing your methods. Using our substantial scientific and regulatory experience, we guide research institutions through privacy and security issues, FDA regulations, and other guidelines related to clinical research and post-market activity in the U.S. and abroad. During FDA inspections or enforcement actions, we negotiate and advocate for you before regulatory bodies.

Intellectual Property

Patenting and licensing the drugs, devices and medical technologies you develop is one of the final steps in the research process. We counsel on intellectual property issues related to pharmaceutical, biotechnology or medical device research and draft and negotiate technology licensing agreements.