Clinical research activities in academic medical centers, hospitals, and universities continue to generate extraordinary breakthroughs, discoveries, and innovations that advance health care. However, the financial investments made by sponsors of research including governmental agencies, biotechnology companies, and foundations create numerous managerial and administrative challenges. Moreover, there is considerable regulatory oversight clinical research in particular. These oversight activities have enormous implications for providers, payers, and biotech companies who must build effective infrastructures to handle the immense financial, operational and compliance related concerns.

Dentons’ health care professionals have deep work experience with organizations engaged in the design, development, and delivery of research activities including human subjects research. Our lawyers and other health care professionals help our clients identify and assess their operational gaps, determine opportunities for improvement, and then create tools, templates, training, process maps, policies, work plans, and compliance management guidance. These efforts help strengthen organizational compliance and fortify plans for minimizing the considerable risks associated with carrying our clinical research projects.

Our team also brings vast capabilities to helping clients manage research financial compliance. We help them tighten financial controls, sharpen accounting practices, and work within federal regulatory guidelines associated with direct and indirect costs, effort reporting, and other grants management issues.

The breadth of our experience with leading universities, academic medical centers, hospitals, and health systems offers us insights into best practices. Our team’s collective expertise is further bolstered by the prior work experiences and backgrounds of our team which includes former compliance officers, clinical research coordinators, clinical trials office administrators, OIG officials, and research accountants.

Look to our integrated team for innovative business advisory and legal solutions for strengthening compliance in clinical research program management including:

• Operations & infrastructure assessment
• Management outsourcing
• Clinical research performance improvement
• Clinical trial billing performance
• Strategic planning / study design
• Trials & Grants Pre- & Post-award support
• Research accounting (including close outs)
• GCPs assessments
• Investigations & litigation support
• Coverage analysis and training
• Study management techniques

Our clinical research compliance services go beyond aiding provider organizations. We are routinely engaged by biotechnology and pharmaceutical companies in need of our services such as the following:

• R&D, Medical Affairs, Sales & Marketing Policy/SOP review
• PhRMA/AdvaMed Code compliance
• Publication planning (according to ICMJE standards)
• Grants and Investigator-Initiated Trial (IIT) management
• Off-label marketing and promotion compliance
• FDA and internal audit support
• Interactions with health care professionals
• Physician contracting, Stark, and anti-kickback
• Good Clinical Practices (GCP) & Quality Assurance Assessments
• Data privacy and document management
• Compliance and business process training
• Compliance effectiveness assessments & Risk management planning