Baker & Daniels' clinical research professionals use their substantial scientific and regulatory experience to advise and guide clients through an increasingly complex maze of regulatory requirements for clinical research. Our clinical research team includes lawyers and consultants with experience in every aspect of drug, device and diagnostic clinical research, including trial development, regulatory strategy, contracting, publications, privacy and security issues, and reimbursement. By working with Baker & Daniels' FDA, corporate, intellectual property, compliance, reimbursement and other professionals, as needed, we are able to provide clients with an integrated approach to help ensure that their clinical trials are operated efficiently, cost effectively and successfully.
Our clinical research clients range from large academic institutions to smaller, innovative start-ups — and everything in between. We advise clients on domestic and international drug, device, diagnostic and combination product trials. We assist clients with the preparation and negotiation of research organization agreements, consent forms and clinical trial and investigator disclosure agreements. Baker & Daniels' professionals also assist clients with corporate compliance program assessment and design, monitoring and auditing compliance activities, third-party vendor compliance, FDA inspections, enforcement responses and other issues related to medical and clinical research and post-market activities in the United States and abroad.
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