Optimize Your Research Compliance and Site Operations
Research compliance is an ongoing commitment. It is the cornerstone of ethical research practices. Our team of experts works with you to navigate the various regulations and guidelines from governing bodies in an evolving and complex regulatory landscape.
Research Compliance and Site Operations
Our team will help you develop, implement, and uphold research compliance and administrative practices in alignment with the federal regulations, state and local laws and industry best practices.
Our team of experts includes deep expertise from R1 institutions and works with you to address:
- Complex regulatory landscapes: We help with navigating various regulations and guidelines from different institutions and governing bodies.
- Resource constraints: We work with research administrations to provide interim, experienced personnel to allow you to scale operations as needed to maintain critical compliance requirements.
- Monitoring: Our team provides post-approval monitoring and auditing services to ensure compliance with regulatory requirements and data safety monitoring plans.
Tailored Offerings
Engage with our team of experts to mitigate risks, protect research integrity, and maintain compliance.
- HRPP assessment and revitalization
- Research compliance assessments and revitalization
- Monitoring/Auditing
- sIRB program evaluation and processes
- SOP development
Engage top-level professionals to fill short- and long-term core team roles both on-site and remotely, bringing necessary skills and experiences to your projects.
- HRPP director
- IRB director/manager
- IRB member
- IRB analyst
- Regulatory coordinators
- Clinical research coordinators (CRC)
- Research nurses
Our Research Compliance Expertise
Cheryl Byers, MHA, CIP, CHRC
SVP Consulting
Cheryl has over 20 years of experience in research compliance. She has provided compliance oversight to programs at academic medical centers, NIH funded sites and institutions including pre-clinical, IRB, conflict of interest, HIPAA Privacy, research misconduct, institutional biosafety, radiation safety, export control, and facility security. Prior to joining Advarra, Cheryl has served in senior leadership roles for Protocol Review, Monitoring Systems & Regulatory Affairs at a NCI-designated cancer center as well as in research compliance at a major research university.
Joshua Fedewa, MS, CIP
Director, Research Compliance
Faith Bertrand, CIP
Senior Consultant
Lisa Rooney, JD
Managing Expert
John Baumann, PhD, MA, BA
Managing Expert
Cynthia Hahn
Managing Expert
Grant Application Support
When developing a grant budget, how do you ensure you’ve included everything your project will need?
Maximize your funding request and avoid resources surprises down the road with Advarra’s support. Download our grant application checklist for an outline of common (and sometimes forgotten) elements you may need to include in your budget.
HRPP Support
Each research program is different and comes with unique needs. We take time to carefully understand your processes and apply our expertise to bring out the best in your program. We look beyond the IRB to evaluate your entire HRPP. Revitalize your HRPP with customized consulting support.
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 on 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
Top-Tier University Stays Compliant with Advarra’s HRPP Assessment
A top -tier university worked with Advarra’s Institutional Research Center of Excellence to assess HRPP compliance with federal regulations
Beginner’s Guide to Clinical Trial Billing Compliance
Ensuring proper compliance within clinical trials is confusing, so here are best practices to ensure charges and claims are correctly routed
Developing an Emergency Preparedness Plan for your HRPP
Emergency preparedness plans help institutions plan, prepare for, and respond to emergencies as they arise.
