Advarra’s experts can work directly with your team to provide consulting and evaluation services related to Good Practices (GxPs), quality assurance (QA), regulatory compliance and human research protection (HRP) for research.

GxP/GCP Auditing and Compliance Consulting

For any aspect of study conduct, you can trust Advarra® to provide practical compliance assessment and advice.

HRP/IRB Consulting

Advarra will help you develop, implement and uphold human protections practices in alignment with your desired workflows.

Global Capabilities

From laboratories to sites to technology vendors, Advarra can review and provide recommendations for every touchpoint in your programs.

Advarra Consulting’s proactive, collaborative approach helps pharmaceutical, medical device and biopharmaceutical firms, as well as CROs and academic institutions, strengthen and grow research enterprises. Advarra’s experts can provide:

  • Good Clinical Practice (GCP) site and vendor audits
  • GLP/GMP/GVP audits
  • Onsite GCP support
  • SOP review and authoring
  • Submission document quality assurance (QA) and quality control (QC)
  • Mock regulatory inspections
  • Clinical quality assurance (CQA) consulting

Through these services, we will help your organization:

  • Develop and establish a robust quality management system
  • Implement an effective quality plan and audit program
  • Maintain compliance and minimize regulatory risk
  • Strengthen clinical quality assurance practices that lead to data integrity
  • Protect the safety and welfare of clinical trial subjects

Beyond experiencing seamless interaction with an expert team, Advarra’s clients also enjoy access to the Advarra cloud, a secure document sharing solution for fast and easy handling of sensitive information.

Providing Consultation Without Confusion

Case Studies

Advarra’s multidisciplinary team and service history offer a distinct advantage no other partner can match. Advarra Consulting has the experience and expertise to help you address your research challenges. When you need answers, ask Advarra.

view case studies

The Advarra Consulting Team

With an extensive legacy of working in partnership with clients to review and reinforce research quality and compliance, Advarra will bring hard-earned insight and knowledge to your research practice and programs. Advarra will work directly with your team to evaluate your current quality management system (QMS) and standards to help implement enhanced practices aligned with current regulations and industry trends. No matter the size, scope or complexity of your research program, Advarra will position you with a strong quality program for compliance — and success.

Advarra’s highly knowledgeable team of QA and HRP professionals have served as physicians, research nurses, study coordinators, project managers, IRB members, IRB administrators, clinical monitors, data reviewers and auditors. These team members have 10 to 35 years of relevant experience.

The Advarra Consulting Advantage

  • Global reach
  • Highly customized services
  • Robust archive of QA and HRP resources
  • Primary focus on quality needs and regulatory requirements
  • Collaborative partnership with clients
  • Solutions for research programs of all sizes and types

US Company/Global Services

  • Exceptional expertise in clinical trial auditing support and assistance in developing CQA programs and infrastructure
  • Considerable breadth of service in supporting clinical vendors, clinical laboratories, investigator sites, Trial Master File (TMF) management, data and documents, pharmacovigilance, Risk Evaluation and Mitigation Strategy (REMS) programs and computer system audits
  • Expertise in non-clinical laboratory, bioanalytical and good manufacturing auditing and advisory services
  • Services that complement typical auditing practices, including:
    • Regulatory inspection readiness and preparedness: mock inspections, training and support for sponsors and sites
    • Clinical vendor oversight management training and consulting
    • Virtual QA services: Infrastructure support and planning, quality program plans, training, ad-hoc support
    • Quality systems and standards development: Advisory consultation and development of optimal processes, workflow and standards.
      • Biosafety process development and support: Institutional Biosafety Committee (IBC) startup and registration; IBC education and training
    • Federal agency response advisory services
    • Specialized and strategic ad-hoc consulting

Human Research Protection (HRP) Consulting

Advarra takes pride in being a long-standing beacon of ethical guidance for the research community. The experts at Advarra can provide consultation to your ethics program, including IRB and DSMB setup and support; IRB education and training; CGP training and assistance with accreditation services. Advarra also provides ad-hoc regulatory compliance input and support to ensure your research program is adherent with the most recent requirements and best practices.

Regulatory Authority Knowledge

  • US Food and Drug Administration (FDA)
  • US Office for Human Research Protection (OHRP)
  • European Medicines Authority (EMA)
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Health Canada regulations
  • Local country regulations
Click to enlarge

Ready for Solutions That Are Altogether Better?

Tell us what you’d like Advarra to do for your research program.