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The Advarra Advantage: Our Expertise

The Advarra advantage is built on our industry and domain expertise. Our experts are change agents and thought leaders with deep experience in clinical research. Together, we solve mission-critical challenges and bring life-changing therapies to participants faster.

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Cheryl Byers, MHA, CIP, CHRC
Principal, Advarra Consulting Institutional Research CoE

With over 20 years’ research compliance experience, Cheryl Byers is an expert in human subject research. She has provided oversight to programs such as pre-clinical, conflict of interest, HIPAA Privacy, research misconduct, institutional biosafety, radiation safety, export control, and facility security. Byers is a former AAHRPP site visitor and step 1 reviewer; is certified in healthcare research compliance; and is a certified IRB professional.

Judith Carrithers, JD, MPA
Director of Regulatory Affairs

Judith Carrithers has worked in the field of human subject protection for more than 20 years. Prior to joining Advarra, she served as the Assistant Dean for Human Research Protection at Johns Hopkins University School of Medicine. Carrithers co‐leads the Ethics and Regulatory Core for the NIH Health Care Systems Research Collaboratory. She is also a consultant on regulatory issues in the field of human subject protection, has presented at local, national and international meetings.

Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP
Director of Biosafety Services

Prior to joining Advarra, Daniel Eisenman served as Biosafety Officer at UNC Chapel Hill and the Medical University of South Carolina. Eisenman holds a PhD in Molecular Biology and Immunology from Augusta University, as well as various professional certifications in biological safety, including the Registered Biological Safety Professional (RBP) and Certified Biological Safety Professional (CBSP) certifications through the American Biological Safety Association (ABSA) and as a Specialist Microbiologist in Biological Safety (SM(NRCM)) through the American Society for Microbiology (ASM) National Registry of Certified Microbiologists (NRCM). He is also a devoted longtime educator, having taught microbiology at the undergraduate and graduate levels. Eisenman currently serves on the ABSA Owned Course Committee and is a regular speaker at clinical research conferences.

Luke Gelinas, PhD
IRB Chair

Luke Gelinas is an IRB chairperson at Advarra, where he provides analysis and guidance on complex ethical issues arising in the course of clinical research study design and human participant protection. Previously, Gelinas led collaborative, multi-stakeholder projects addressing foundational and practical issues in research ethics including social media use, clinical trial priority-setting, and has explored the ethical and regulatory parameters paying research participants. His written work has appeared in leading medical and bioethics journals, and Gelinas frequently lectures on various issues surrounding research ethics and human participant protection.

Joseph Lamendola, PhD
Principal, Advarra Consulting Regulatory CoE

With over 30 years of leadership experience, Joseph Lamendola advises companies on all key agency interactions, including pre IND, end of Phase II, pre NDA and advisory committee meetings. Lamendola also advises on regulatory structure and process, as well as alignment between regulatory, clinical, and commercial in the drug development process.

Adrian Otte, MB, BCh
Principal, Advarra Consulting Clinical CoE

With over 35 years’ experience leading Global Clinical Operations at companies such as Pfizer, Amgen, Parexel and AstraZeneca, Adrian Otte is widely considered to be an industry leader in clinical development. Adrian is recognized for his ability to develop strong, diverse teams of talented individuals who share his passion for drug development and relentless focus on continuous improvement.

Robert Romanchuk, BSHS, CHRC, CIP, CCRC
IRB Chair

Robert Romanchuk has two decades of experience in clinical research leadership in both realms of research operations and human subjects protections. He has spoken widely on topics ranging from vulnerable populations to the complexities of device studies. Romanchuk currently serves as a Chairperson at Advarra IRB with dual CIP/CCRC certifications.

James Riddle, MCSE, CIP, CPIA, CRQM
VP of Research Services & Strategic Consulting

Prior to joining Advarra, James Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers. In addition, he was an Association for the Accreditation of Human Research Protection Programs (AAHRPP) site visitor and was the vice president of operations and director of technology at another large central IRB. Riddle is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R); a member of the Clinical Trials Transformation Initiative (CTTI) Steering Committee; a board member of the Northwest Association for Biomedical Research (NWABR); and a leader of the Alliance for Clinical Research Excellence and Safety (ACRES) Site Accreditation & Standards Initiative (SASI) technology domain accreditation team.

Michele Russell-Einhorn
Chief Compliance Officer and Institutional Official

Michele Russell-Einhorn has over 30 years of professional experience, including service as the conflicts of interest attorney for the National Institutes of Health (NIH) and Director of Regulatory Affairs for the US Department of Health and Human Services Office for the Protection from Research Risks and its successor office, the Office for Human Research Protections. Russell-Einhorn is also a co-chair of a DHHS subcommittee related to human research protections and a founder and leader of the IRB Directors Group within the National Comprehensive Cancer Network.

Wendy Tate, PhD, GStat
Director, Research Operations

Wendy Tate’s work is focused on the evaluation of clinical research administration, including the development and testing of quantitative methods to measure and assess protocol feasibility and workload. Her passion is to provide helpful and meaningful processes and tools to clinical research professionals that streamline clinical research practices and better the clinical research enterprise as a whole. Prior to Advarra, Tate spent 15 years at the University of Arizona in various roles within human laboratory, human subjects protection, and clinical research roles, including leadership roles with the IRB and Cancer Center clinical trials office.

Joan Versaggi, MBA
Principal, Advarra Consulting Quality CoE

With over 35 years’ global experience in the pharmaceutical industry, Joan Versaggi has a diverse range of quality, compliance, clinical and business process improvement consulting knowledge and expertise. Versaggi has led teams of quality and compliance professionals in developing and implementing strategic plans to support quality management systems and processes to ensure compliance and adherence to applicable quality standards in clinical research.

Barbara Schneider, PhD, MBA
Executive Director, Biostatistical Services

Barbara Schneider is Executive Director of Biostatistical Services at Advarra. She heads Advarra’s independent data monitoring committee and endpoint adjudication services, which provide trusted safety oversight for hundreds of clinical trials around the world. Prior to joining Advarra, Schneider was the founder and CEO of Watermark Research Partners. Watermark was the first company to provide independent data safety monitoring board services and endpoint adjudication to the clinical trial industry. (Watermark joined Advarra in 2021.)