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Institutional Research Center of Excellence

Optimize Your Research Administration, Compliance, and Operations

Strong research administration infrastructure is critical for success in today’s ever-growing research industry.

About Our Institutional Research Center of Excellence

Advarra Consulting takes pride in being a long-standing beacon of ethical guidance for the research community. We will help you develop, implement, and uphold research compliance and administrative practices in alignment with the federal regulations, state and local law, and industry best practices.

The Institutional Research COE empowers the research community to achieve excellence through:

  • Facilitating shared responsibility for research and research compliance ethical conduct
  • Supporting institutions, investigators, and research teams through process improvement, innovative technologies, and education
  • Propagating best operational practices to maximize research activity efficiencies

Tailored Offerings

Ensure regulatory compliance within clinical research programs

  • Human research protection program (HRPP)
  • Institutional review board (IRB)
  • Institutional care and use committee (IACUC)
  • Institutional biosafety committee (IBC)
  • Conflict of interest (COI)
  • 21 CFR Part 11 and computer system validation
  • Export control/research security
  • Research misconduct investigations
  • HIPAA privacy and security rules
  • EU general data protection regulation (GDPR)

Streamline and fortify the research architecture of your health system

  • Data privacy practices management
  • Data sharing and material transfer management
  • Protocol and informed consent development
  • Research administration revitalization
  • Research technologies evaluation and implementation
  • Policy/standard operating procedure gap analysis and development

Site level assistance with clinical trial operations

  • Feasibility review
  • Scientific review
  • Regulatory assessment/assistance with IND/IDE applications
  • Standard operating procedure development
  • Monitoring/auditing
  • Study startup
  • Study close out

Significant expertise when implementing compliant human research protection programs

  • Research staffing solutions
  • HRPP health check
  • Accreditation application support
  • Policy/standard operating procedures gap analysis and development
  • Training for investigators and other research staff
  • Audit prep and communications with federal authorities
  • Completely managed local IRB service

A Snapshot of Our Institutional Expertise

Cheryl Byers, MHA, CIP, CHRC ​
VP & Principal, Institutional Research CoE

Former IRB Director, Wake Forest University School of Medicine; Assistant VP Research Compliance, University of South Florida; and Director, Protocol Review & Monitoring Systems and Regulatory Affairs, Moffitt Cancer Center

Lisa Rooney, JD
Managing Director, Advarra Regulatory

David Babaian, JD, LLM, CIP, RAC
Associate Director, Advarra Regulatory

Jennifer Richards, MS, MBA, CCRP
Senior Consultant,  Advarra Regulatory

Faith Bertrand
Consultant, Advarra Regulatory

James Riddle, MCSE, CIP, CPIA, CRQM
Vice President, Advarra Research Services and Strategic Consulting

Bette Bayne
Vice President, Advarra Business Development, Institutional Services

Wendy Tate, PhD
Director of Research Operations, Advarra

Cynthia Hahn
Independent Consultant

Let Our Experience be Your Advantage

At Advarra Consulting, we are more than industry experts. We are former executives and practitioners. We are professionals with deep experience and a relentless focus for continuous improvement.

We understand your challenges and partner to deliver customized solutions to fit your unique needs. We know what it takes to build the infrastructure to establish, administer, and evolve compliant research programs. We stand ready to help you deliver.

Related Resources

 
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sIRB Review for Multicenter Research: A Guide for Institutions

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Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...

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