About Our Law Firm
We are a boutique law firm that specializes in research compliance matters with a focus on providing practical advice to our clients.
We provide regulatory advice, develop policies and procedures, and advise on compliance issues that arise as part of participating in research studies.
Representative Clients
- Academic Medical Centers
- Hospitals
- Midsize and Large Health Systems
- Physician Practices
- Biotechnology and Pharmaceutical Companies
- Clinical Research Organizations
- Healthcare Data Solutions Organizations
Our Team
Genevieve deLemos
As the former Research Compliance Officer for Atrium Health, Genevieve provided regulatory support on a variety of issues for the research program ranging from the proper conduct of research to conflicts of interest. Genevieve took an immersive approach to the research program, partnering closely with research stakeholders to develop education, training and policies and procedures while serving as a practical resource for the day to day operational and regulatory needs of the system.
Prior to joining Atrium Health, Genevieve worked as a healthcare and compliance lawyer for Genzyme Corporation where she managed internal and government compliance investigations, provided legal advice on a variety of regulatory and industry requirements and supported the free drug programs. Prior to her legal career, she worked as a research associate on a variety of BRCA1 and 2 studies and spent several summers working in a lab.
Genevieve lives in Charlotte, North Carolina with her family where she enjoys running, traveling and reading.
Education
Juris Doctorate | Temple University Beasley School of Law, 2004
Bachelor of Arts | University of Pennsylvania, 1998
Admitted to practice in Massachusetts
Andrea Wever
As former Senior Associate General Counsel at a large health care system, Andrea advised on legal and regulatory matters related to research and sponsored programs, including providing advice to the IRB, IACUC, Office of Sponsored Programs, and the Office of Clinical and Translational Research. Andrea has extensive experience advising on the full scope of matters pertaining to the conduct of research. This includes pre-clinical and all phases of clinical trials, outcomes research, and investigator-initiated research.
Andrea is experienced in providing advice on federal regulatory matters including FDA, OHRP, HIPAA, FCPA, Stark and Anti-Kickback. Andrea has drafted and negotiated numerous contracts related to research and other sponsored programs and is experienced in drafting policies that comply with applicable regulations and that are practical for clients to implement.
Andrea lives in Davidson, NC with her family and enjoys reading, cooking and yoga in her free time.
Education
Masters in Public Health | University of North Carolina at Chapel Hill, 2006
Juris Doctorate | University of North Carolina at Chapel Hill, 2005
Bachelor of Science | University of North Carolina at Chapel Hill, 2001
Admitted to practice in North Carolina
With our in-house experience and background, we accurately assess a client’s needs and resources and provide tailored services to each client.
As a boutique firm, we provide our specialized services in a cost-effective manner to maximize the value that each client receives. We consider ourselves part of our client’s team and have a strong interest in setting each client up for success in its research endeavors.
Let’s Get Started
If you would like to participate in clinical trials and research, or are currently participating in research but need assistance with compliance and practice policies, we can help.
