Research Compliance Consulting can assist you in evaluating and addressing the administrative, regulatory and ethical issues that are specific to clinical research as well as those that apply to human subjects research more broadly

• FDA regulations
• OHRP regulations
• Human subjects protection programs and accreditation
• Institutional Review Board (IRB) review processes
• IRB operations and documentation
• Human subjects research monitoring programs
• Informed consent process and documentation
• Researcher education on human subjects research ethics and regulations
• Conflict of interest in human subjects research
• Institutional conflict of interest policies
• Confidentiality and privacy: HIPAA, laws restricting use of social security numbers and beyond
• Tissue and data repositories
• Stem cell research policies and procedures
• Data Safety Monitoring
• Clinical research associate training and development programs
• Clinical research budgeting processes and policies
• Clinical research billing processes
• Clinical research agreement clauses and provisions, including human subject injury provisions, data access rights and more
• Sponsor monitor access policies and processes
• Institutional program for holding IND
• Registering clinical research on clinical trials.gov
• Investigational device policies and processes
• Investigational drug policies and processes