Regulation and Compliance
Research is a highly regulated area and may seem daunting, but protecting patients is of the utmost importance.
We help researchers navigate the complex regulatory landscape and provide structure and a framework for a compliant research program, regardless of size.
- Regulatory Advice, including guidance on matters related to FDA, OHRP, USDA, HIPAA, Anti-Kickback Statute, and Stark
- Human subjects protection
- Conflicts of Interest
- IRB Compliance
- IACUC/vivarium compliance
- Foreign research implications, including compliance with the Foreign Corrupt Practices Act (FCPA)
Clinical Trials Consulting
Participating as a site or a Principal Investigator in a clinical trial can be a rewarding experience. We provide resources and advice to assist you through this process.
We are able to scale our services to provide strategic advice and counsel on specific clinical trials to a more comprehensive review of research programs in general.
- Strategic advice on investigational drug trials and medical device trials
- Sponsored Programs
- Investigator Initiated Studies
- Principal Investigator requirements
- Research staff support and requirements
Research Policies & Procedures
Having appropriate policies and procedures in place is critical in developing and maintaining a research program.
We create new policies and procedures or review and update any existing policies and procedures to guide clients’ research programs and strategy. We constantly monitor emerging issues in research and are able to quickly develop and provide education and training on these areas.
- Creating research procedures
- Developing compliant policies
- Staff training & strategic operational support
- Maintaining compliant research studies and programs