STRATEGIC ENABLEMENT SERVICES

HRPP/IRB Advisory Services

Advarra’s Human Research Protection Program (HRPP)/Institutional Review Board (IRB) Advisory services include accreditation support, policy and procedure development, technology transformation support, single IRB (sIRB) readiness and reliance support, and comprehensive staffing solutions.

Delivered by industry experts, these services ensure alignment with regulations to meet the highest standards for quality, ethics, and compliance.

Why Choose Advarra’s HRPP/IRB Advisory?

Deep Regulatory and Accreditation Knowledge

Expertise in policies of the Office for Human Research Protection (OHRP) and accreditation requirements of the Association for the Accreditation of Human Research Programs, Inc (AAHRPP), helping sites and institutions remain compliant with standards and achieve certifications faster

Institutions have achieved AAHRPP accreditation in

just 9 months

Leader in IRB Services

Experience and knowledge to help meet regulatory and quality standards and provide IRB support

central IRB

Trusted by more than 3500 sites and institutions

HRPP/IRB Advisory Services

HRPP development and revitalization

HRPP development and revitalization provides expert support to build, strengthen, or refresh the site’s Human Research Protection Program (HRPP) to drive enhanced compliance, efficiency, and ethical oversight across the research enterprise.

Single IRB (sIRB) readiness

Single IRB (sIRB) readiness and reliance support establishes sIRB workflows, executes reliance agreements that clearly define roles and responsibilities, and implements systems to streamline multi‑site review, enhance efficiency, and simplify oversight while ensuring regulatory compliance.

IRB inspection readiness

IRB inspection readiness provides strategic consulting to ensure research sites are ready for inspection by regulatory authorities – identify gaps, refine processes, and ensure seamless regulatory compliance.

AAHRPP accreditation support

AAHRPP accreditation support prepares the site’s HRPP to meet the highest ethical and compliance standards to achieve or maintain accreditation. Our team of experts assist with application preparation and site visits.

Protocol and ICF development

Protocol and ICF Development delivers well-structured, operationally feasible protocols and patient-centric consent forms aligned with regulatory expectations to enable efficient review and enrollment.

Technology transformation support

Technology transformation support independently evaluates and guides the implementation of eIRB systems, including integration with other electronic research systems, to streamline workflows, improve visibility, and deliver sustainable long-term value.

Comprehensive staffing solutions

Comprehensive staffing solutions quickly deploys experienced IRB directors, coordinators, QA specialists, and other regulatory staff members to fill gaps, manage workload, and boost organizational capacity.

Customized training for staff and investigators

Customized training for staff and investigators provides role‑based, scenario‑driven training mapped to your SOPs, industry best practices, and regulations—delivered live or on‑demand—to strengthen compliance and performance.

Policy & procedure gap analysis and development

Policy and procedure gap analysis and development identifies deficiencies and builds practical, compliant policies and SOPs aligned with federal regulations, ICH GCP E6(R3), industry best practices, and institutional standards.

Current state program assessments

Current state assessments and recommendations provide independent evaluations of processes, technology, structure, and staffing with prioritized recommendations, quick wins, and an actionable roadmap to elevate performance and compliance.

Comprehensive research compliance expertise

Comprehensive research compliance experts provides guidance across areas such as HRPP, HIPAA, COI, and Research Misconduct, to help sites stay algined with regulations, minimize risk, and strengthen oversight across the research enterprise.

How our services have helped sites

Ready to streamline your accreditation and IRB readiness process?

Learn more about Advarra’s HRPP/IRB Advisory Solution for Research Sites.

MCA timelines impact trial activation efficiency, with staffing shortages a key barrier. Many sites find sponsors receptive to covering MCA-related costs.