Medical Research Support
Jameson & Powers has represented most of the various parties in clinical research trials, including Phase I and Phase II research sites performing clinical drug trials, small and medium-sized pharmaceutical sponsors in all phases of clinical trials, and independent physician researchers. We have acted as outside general counsel of several research networks, and we have significant understanding and familiarity with the complicated regulatory issues involved.
Our experience includes:
• Drafting and negotiating clinical research agreements; both as a master agreement with work orders and a single research study agreement
• Negotiation of CRO contracts
• Analysis and negotiation of laboratory research agreements, in the context of CAP and CLIA compliance
• Formation of institutional review boards, and assisting in contracts between a central IRB and a research network
• Working with other committees, such as IBC and gene therapy advisory committees
• Review of Informed Consent Documents to verify compliance with applicable law (including HIPAA) and consistency with the clinical trial agreement
• Drafting joint venture agreements between hospitals and medical researchers, and research clinics and pharmaceutical companies.
Jameson & Powers appreciates the importance of research trials, and is committed to being part of a successful team to bring new drugs and devices to market in a timely fashion.