Advarra Consulting’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.

Regulatory Consulting

If you need help developing innovative solutions to complex regulatory or compliance challenges, Advarra is the answer. Our consultants are agile, flexible, and top experts in their fields.

Clinical Quality Assurance Consulting

Our expert assessment of quality management and GCP compliance helps ensure you maintain compliance with regulations and GCP.

Research Administration and Human Research Protection (HRP) Consulting

Streamline and fortify the research program at your institution or health system. Advarra offers creative, proven solutions to boost your human subject research protection program.

Data Protection and Technology Compliance Consulting

Advarra brings strong technology expertise with a deep understanding of life sciences to ensure appropriate compliance and move your research forward.

Providing Consultation Without Confusion

Advarra Consulting’s proactive, collaborative approach helps pharmaceutical, medical device, and biopharmaceutical firms, as well as CROs, academic institutions, health systems, and other research sites, strengthen and grow research enterprises. Our consultants provide the support needed to transform your research organization. We specialize in custom solutions to fit your organization’s unique needs in clinical trials, human research protection issues, and more.

Through these services, we will help your organization:

  • Develop and establish a robust quality management system, human subject protection program, and/or research administration strategy
  • Implement an effective quality plan and audit program
  • Maintain compliance and minimize regulatory risk
  • Strengthen clinical quality assurance practices that lead to improved data integrity
  • Protect the safety and welfare of clinical trial participants

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.

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.

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The Advarra Consulting Team

With an extensive legacy of working in partnership with clients to review and reinforce research quality and compliance, Advarra brings hard-earned insight and knowledge to your research practice and programs. Advarra will work directly with your team to evaluate your current program and standards to help implement enhanced practices aligned with current regulations and industry trends. An experienced point of contact provides dedicated management support for each project.

The world’s foremost leaders in life sciences and clinical research consulting, Advarra moves your research forward with the highest quality solutions that enhance and optimize the clinical research process. We deliver collaborative custom solutions to match your process with our expertise. 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 research professionals and regulatory experts 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. We also maintain a worldwide network of consultants, specializing in areas including IBCs and biologic IND applications, mHealth software as a device, other specialized regulatory submissions, international accreditation, and more.

The Advarra Consulting Advantage

  • Global reach
  • Highly customized services
  • Dedicated point of contact to manage each project
  • Robust archive of QA and research administration 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

  • 120+ employee and consultant experts worldwide
  • 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, and ad-hoc support
    • Quality systems and standards development: Advisory consultation and development of optimal processes, workflow, and standards
    • Federal agency response advisory services
  • Human research protection (HRP) consulting
  • Research administration consulting and interim staffing support
    • Regulatory and technology compliance consulting
    • Biosafety process development and support: institutional biosafety committee (IBC) startup and registration; IBC education, training, and auditing
  • Specialized and strategic ad-hoc consulting

Regulatory Authority Knowledge

  • US Food and Drug Administration (FDA)
  • US Office for Human Research Protection (OHRP)
  • International Conference on Harmonisation (ICH)
  • European Medicines Authority (EMA)
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Health Canada regulations
  • Local country regulations
 
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Ready for Solutions That Are Altogether Better?

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